A Phase 2, Multi-Arm Study of Magrolimab in Patients With Solid Tumors
Phase: PHASE2
Conditions: Solid Tumor
Sponsor: Gilead Sciences

C LI NI C A L S T U D Y P R O T O C O L
St u d y Title:
A P hase 2, M ulti- Ar m St u d y of Ma gr oli ma b i n Patie nts Wit h S oli d 
T u m ors
Pl ai n L a n g u a ge S h ort 
Title:
St u d y of Ma gr oli ma b i n Patie nts Wit h S oli d T u m ors
S p o ns or:
Gilea d Scie nces, I nc.
3 3 3 La kesi de Dri ve
F oster Cit y, C A 9 4 4 0 4
I N D N u m ber:
E u dr a C T N u m ber:
Cli nic al Tri als. g o v 
I de ntifier:
1 1 7 6 8 7
2 0 2 0- 0 0 5 2 6 5- 1 4
N C T 0 4 8 2 7 5 7 6
I n dic ati o n:
S oli d T u m ors
Pr ot oc ol I D:
G S- U S- 5 4 8- 5 9 1 8
C o nt act I nf or m ati o n: 
T he me dical m o nit or na me a n d c o ntact i nf or mati o n will be 
pr o vi de d o n t he Ke y St u d y Tea m C o ntact List.
Pr ot oc ol Versi o n/ D ate 
A me n d me nt 5:
2 4 Oct o ber 2 0 2 3
A me n d me nt Hist or y: 
Ori gi nal:
1 5 Dece m ber 2 0 2 0
A me n d me nt 1:
0 3 Marc h 2 0 2 1
A me n d me nt 2:
1 5 Marc h 2 0 2 1
A me n d me nt 3:
1 4 Dece m ber 2 0 2 1
A me n d me nt 4:
2 7 Ja n uar y 2 0 2 2
Hi g h-le vel s u m mar y of t he hist or y of a me n d me nts is pr o vi de d i n 
A p pe n di x 1 0 .
C o u ntr y-s pecific 
Re q uire me nts:
C o u ntr y-s pecific re q uire me nts, as a p plica ble, are liste d i n 
A p pe n di x 9 .
T his st u d y will be c o n d ucte d u n der U nite d States F o o d a n d Dr u g A d mi nistrati o n i n vesti gati o nal 
ne w dr u g (I N D) re g ulati o ns ( 2 1 C o de of Fe deral Re g ulati o ns Part 3 1 2); h o we ver, sites l ocate d i n 
t he E ur o pea n Ec o n o mic Area, U nite d Ki n g d o m, a n d S witzerla n d are n ot i ncl u de d u n der t he I N D 
a n d are n ot c o nsi dere d t o be I N D sites.
T his st u d y will be c o n d ucte d i n c o m plia nce wit h t his pr ot oc ol a n d i n acc or da nce wit h t he et hical 
pri nci ples t hat ha ve t heir ori gi n i n t he Declarati o n of Helsi n ki, a n d t hat are c o nsiste nt wit h 
I nter nati o nal C o u ncil f or Har m o nisati o n (I C H) G o o d Cli nical Practice ( G C P) a n d a p plica ble 
re g ulat or y re q uire me nts.
GI L E A U 

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 2
2 4 Oct o ber 2 0 2 3
C O N FI D E N TI A LI T Y S T A T E M E N T
T he i nf or mati o n c o ntai ne d i n t his d oc u me nt, partic ularl y u n p u blis he d data, is t he pr o pert y or 
u n der c o ntr ol of Gilea d Scie nces, I nc., a n d is pr o vi de d t o y o u i n c o nfi de nce as a n i n vesti gat or, 
p ote ntial i n vesti gat or, or c o ns ulta nt, f or re vie w b y y o u, y o ur staff, a n d a n a p plica ble 
i nstit uti o nal re vie w b oar d or i n de pe n de nt et hics c o m mittee. T he i nf or mati o n is o nl y t o be use d 
b y y o u i n c o n necti o n wit h a ut h orize d cli nical st u dies of t he i n vesti gati o nal dr u g descri be d i n 
t he pr ot oc ol. Y o u will n ot discl ose a n y of t he i nf or mati o n t o ot hers wit h o ut writte n 
a ut h orizati o n fr o m Gilea d Scie nces, I nc., e xce pt t o t he e xte nt necessar y t o o btai n i nf or me d 
c o nse nt fr o m t h ose pers o ns t o w h o m t he dr u g ma y be a d mi nistere d.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 3
2 4 Oct o ber 2 0 2 3
T A B L E O F C O N T E N T S
T A B L E O F C O N T E N T S................................................................................................................................................ 3
LI S T O F I N- T E X T T A B L E S......................................................................................................................................... 6
LI S T O F I N- T E X T FI G U R E S........................................................................................................................................ 6
P R O T O C O L S Y N O P SI S................................................................................................................................................ 7
G L O S S A R Y O F A B B R E VI A TI O N S A N D D E FI NI TI O N O F T E R M S .................................................................... 1 7
1.  
I N T R O D U C TI O N................................................................................................................................................ 2 0
1. 1.  
Bac k gr o u n d.............................................................................................................................................. 2 0
1. 1. 1.  
Bac k gr o u n d o n Rela pse d/ Refract or y S oli d T u m ors I ncl u di n g Metastatic 
N o n- S mall Cell L u n g Ca ncer, Metastatic Ur ot helial Ca ncer, a n d 
Metastatic S mall Cell L u n g Ca ncer....................................................................................... 2 0
1. 2.   
Ma gr oli ma b ............................................................................................................................................. 2 2
1. 2. 1.   
Ge neral I nf or mati o n .............................................................................................................. 2 2
1. 2. 2.   
N o ncli nical P har mac ol o g y a n d T o xic ol o g y.......................................................................... 2 3
1. 2. 3.  
Cli nical Bac k gr o u n d f or Ma gr oli ma b ................................................................................... 2 5
1. 3.  
I nf or mati o n A b o ut D oceta xel.................................................................................................................. 2 8
1. 3. 1.   
Descri pti o n of D oceta xel....................................................................................................... 2 8
1. 3. 2.  
Cli nical Data f or D oceta xel................................................................................................... 2 8
1. 4.  
I nf or mati o n A b o ut A u xiliar y Me dici nal Pr o d ucts .................................................................................. 2 9
1. 5.  
Rati o nale f or T his St u d y.......................................................................................................................... 2 9
1. 5. 1.  
Safet y R u n-i n C o h ort 1 a n d P hase 2 C o h ort 1 ...................................................................... 3 0
1. 6.  
Rati o nale f or D ose Selecti o n of Ma gr oli ma b.......................................................................................... 3 0
1. 6. 1.  
Safet y R u n-i n C o h ort 1 a n d P hase 2 C o h ort 1 ...................................................................... 3 1
1. 7.  
Ris k/ Be nefit Assess me nt f or t he St u d y................................................................................................... 3 1
1. 8.  
C o m plia nce.............................................................................................................................................. 3 2
2.   
O BJ E C TI V E S A N D E N D P OI N T S...................................................................................................................... 3 3
3.  
S T U D Y D E SI G N................................................................................................................................................. 3 4
3. 1.  
St u d y Desi g n ........................................................................................................................................... 3 4
3. 1. 1.  
Safet y R u n-i n C o h ort 1.......................................................................................................... 3 5
3. 1. 2.  
P hase 2 C o h ort 1.................................................................................................................... 3 7
3. 2.  
St u d y Treat me nts..................................................................................................................................... 3 7
3. 2. 1.  
Safet y R u n-i n C o h ort 1 a n d P hase 2 C o h ort 1 ...................................................................... 3 7
3. 3.   
D urati o n of Treat me nt............................................................................................................................. 3 9
3. 4.   
Disc o nti n uati o n Criteria .......................................................................................................................... 3 9
3. 5.   
Disc o nti n uati o n Fr o m St u d y Criteria/ E n d of St u d y................................................................................ 4 0
3. 6.  
P ostst u d y Care......................................................................................................................................... 4 0
3. 7.  
S o urce Data ............................................................................................................................................. 4 0
3. 8.  
Bi o mar ker Sa m ples t o A d dress t he St u d y O bjecti ves............................................................................. 4 0
3. 8. 1.  
P har mac o ki netics/ Bi o mar ker Sa m ples f or   
 
.................................. 4 2
4.  
P A TI E N T P O P U L A TI O N................................................................................................................................... 4 3
4. 1.   
N u m ber of Patie nts a n d Patie nt Selecti o n............................................................................................... 4 3
4. 1. 1.  
Patie nt Re place me nt.............................................................................................................. 4 3
4. 2.  
I ncl usi o n Criteria..................................................................................................................................... 4 3
4. 3.  
E xcl usi o n Criteria.................................................................................................................................... 4 5
5.  
I N V E S TI G A TI O N A L M E DI CI N A L P R O D U C T S............................................................................................. 4 7
5. 1.  
Ra n d o mizati o n, Bli n di n g, a n d Treat me nt C o des Access........................................................................ 4 7
5. 1. 1.  
Ra n d o mizati o n....................................................................................................................... 4 7
C CI 
C CI-

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 4
2 4 Oct o ber 2 0 2 3
5. 1. 2.  
Bli n di n g................................................................................................................................. 4 7
5. 2.   
Descri pti o n a n d Ha n dli n g of Ma gr oli ma b............................................................................................... 4 7
5. 2. 1.  
F or m ulati o n ........................................................................................................................... 4 7
5. 2. 2.  
Pac ka gi n g a n d La beli n g ........................................................................................................ 4 7
5. 2. 3.  
St ora ge a n d Ha n dli n g............................................................................................................ 4 7
5. 3.   
Descri pti o n a n d Ha n dli n g of D oceta xel.................................................................................................. 4 8
5. 3. 1.  
F or m ulati o n ........................................................................................................................... 4 8
5. 3. 2.  
Pac ka gi n g a n d La beli n g ........................................................................................................ 4 8
5. 3. 3.  
St ora ge a n d Ha n dli n g............................................................................................................ 4 8
5. 4.   
D osa ge a n d A d mi nistrati o n of Ma gr oli ma b............................................................................................ 4 8
5. 5.   
D ose M o dificati o ns a n d Dela ys f or Ma gr oli ma b.................................................................................... 4 9
5. 6.   
Ma gr oli ma b Pre me dicati o n a n d Pr o p h yla xis .......................................................................................... 5 1
5. 7.  
Pri or a n d C o nc o mita nt Me dicati o ns........................................................................................................ 5 1
5. 7. 1.  
Pri or a n d C o nc o mita nt Me dicati o ns Wit h Ma gr oli ma b........................................................ 5 1
5. 7. 2.  
Pri or a n d C o nc o mita nt Me dicati o ns Wit h D oceta xel............................................................ 5 2
5. 8.   
D osa ge a n d A d mi nistrati o n of D oceta xel................................................................................................ 5 2
5. 9.   
D oceta xel Pre me dicati o n a n d Pr o p h yla xis.............................................................................................. 5 2
5. 1 0.   
D ose M o dificati o ns f or D oceta xel........................................................................................................... 5 2
5. 1 0. 1.   
Ne utr o pe nia ........................................................................................................................... 5 2
5. 1 0. 2.   
He patic T o xicit y.................................................................................................................... 5 3
5. 1 0. 3.  
Peri p heral Ne ur o pat h y........................................................................................................... 5 4
5. 1 0. 4.   
Ot her T o xicities..................................................................................................................... 5 4
5. 1 1.   
Acc o u nta bilit y f or I n vesti gati o nal Me dici nal Pr o d uct............................................................................ 5 5
5. 1 1. 1.  
I n vesti gati o nal Me dici nal Pr o d uct Ret ur n or Dis p osal ......................................................... 5 5
6.  
S T U D Y P R O C E D U R E S...................................................................................................................................... 5 6
6. 1.  
Patie nt E nr oll me nt a n d Treat me nt Assi g n me nt....................................................................................... 5 6
6. 2.  
Pretreat me nt Assess me nts....................................................................................................................... 5 6
6. 2. 1.  
Scree ni n g Visit ...................................................................................................................... 5 6
6. 3.  
Ra n d o mizati o n......................................................................................................................................... 5 7
6. 4.  
Treat me nt Assess me nts........................................................................................................................... 5 7
6. 4. 1.  
Pre g na nc y Test ...................................................................................................................... 5 7
6. 4. 2.  
T y pe a n d Scree n a n d Direct A nti gl o b uli n Test..................................................................... 5 7
6. 4. 3.   
Vital Si g ns............................................................................................................................. 5 7
6. 4. 4.  
P h ysical E xa mi nati o n............................................................................................................ 5 8
6. 4. 5.  
Perf or ma nce Stat us................................................................................................................ 5 8
6. 4. 6.  
Electr ocar di o gra ms................................................................................................................ 5 8
6. 4. 7.   
A d verse E ve nts...................................................................................................................... 5 8
6. 4. 8.  
C o nc o mita nt Me dicati o ns...................................................................................................... 5 8
6. 5.  
Safet y Assess me nts ................................................................................................................................. 5 8
6. 6.  
Efficac y Assess me nts.............................................................................................................................. 6 0
6. 7.  
P har mac o ki netic Assess me nts................................................................................................................. 6 1
6. 8.  
I m m u n o ge nicit y ( A nti dr u g A nti b o dies).................................................................................................. 6 1
6. 9.  
Bi o mar ker Assess me nts........................................................................................................................... 6 1
6. 1 0.  
P osttreat me nt Assess me nts...................................................................................................................... 6 2
6. 1 1.   
Assess me nts f or Earl y Disc o nti n uati o n Fr o m St u d y............................................................................... 6 2
6. 1 1. 1.  
Criteria f or Disc o nti n uati o n of St u d y Treat me nt................................................................... 6 3
6. 1 2.  
Criteria f or Disc o nti n uati o n Fr o m St u d y/ E n d of St u d y .......................................................................... 6 3
6. 1 3.  
P ostst u d y Care......................................................................................................................................... 6 3
6. 1 4.  
Sa m ple St ora ge........................................................................................................................................ 6 3
7.   
A D V E R S E E V E N T S A N D T O XI CI T Y M A N A G E M E N T................................................................................ 6 4
7. 1.   
Defi niti o ns of A d verse E ve nts a n d Seri o us A d verse E ve nts................................................................... 6 4
7. 1. 1.   
A d verse E ve nts...................................................................................................................... 6 4
7. 1. 2.  
Seri o us A d verse E ve nts......................................................................................................... 6 4

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 5
2 4 Oct o ber 2 0 2 3
7. 1. 3.  
St u d y Dr u gs a n d Gilea d C o nc o mita nt T hera p y S pecial Sit uati o ns Re p orts ......................... 6 5
7. 2.   
Assess me nt of A d verse E ve nts a n d Seri o us A d verse E ve nts.................................................................. 6 6
7. 2. 1.   
Assess me nt of Ca usalit y f or St u d y Dr u gs, A ut h orize d A x M Ps, a n d 
Pr oce d ures............................................................................................................................. 6 6
7. 2. 2.   
Assess me nt of Se verit y.......................................................................................................... 6 7
7. 3.  
I n vesti gat or Re p orti n g Re q uire me nts a n d I nstr ucti o ns........................................................................... 6 7
7. 3. 1.  
Re q uire me nts f or C ollecti o n Pri or t o St u d y Dr u g I nitiati o n................................................. 6 7
7. 3. 2.   
A d verse E ve nts...................................................................................................................... 6 7
7. 3. 3.  
Seri o us A d verse E ve nts......................................................................................................... 6 7
7. 3. 4.  
St u d y Dr u g S pecial Sit uati o ns Re p orts ................................................................................. 6 8
7. 3. 5.  
C o nc o mita nt T hera p y Re p orts............................................................................................... 6 8
7. 4.  
Re p orti n g Pr ocess f or Seri o us A d verse E ve nts a n d S pecial Sit uati o n Re p orts....................................... 6 8
7. 4. 1.  
Seri o us A d verse E ve nt Re p orti n g Pr ocess............................................................................ 6 8
7. 4. 2.  
S pecial Sit uati o ns Re p orti n g Pr ocess.................................................................................... 6 9
7. 5.   
Gilea d Re p orti n g Re q uire me nts.............................................................................................................. 7 1
7. 6.  
Cli nical La b orat or y A b n or malities a n d Ot her A b n or mal Assess me nts as A d verse E ve nts or 
Seri o us A d verse E ve nts........................................................................................................................... 7 1
7. 7.   
A b n or mal Li ver F u ncti o n Tests............................................................................................................... 7 2
7. 8.  
T o xicit y Ma na ge me nt.............................................................................................................................. 7 2
7. 8. 1.   
Ma gr oli ma b ........................................................................................................................... 7 2
7. 8. 2.   
D oceta xel............................................................................................................................... 7 7
8.  
S T A TI S TI C A L C O N SI D E R A TI O N S................................................................................................................. 7 8
8. 1.   
A nal ysis O bjecti ves a n d E n d p oi nts......................................................................................................... 7 8
8. 2.  
Pla n ne d A nal yses..................................................................................................................................... 7 8
8. 2. 1.   
D ose Deter mi nati o n A nal ysis................................................................................................ 7 8
8. 2. 2.  
Pri mar y A nal ysis................................................................................................................... 7 8
8. 2. 3.  
Fi nal A nal ysis........................................................................................................................ 7 8
8. 3.   
A nal ysis C o n ve nti o ns.............................................................................................................................. 7 8
8. 3. 1.   
A nal ysis Sets ......................................................................................................................... 7 8
8. 3. 2.   
Data Ha n dli n g C o n ve nti o ns .................................................................................................. 7 9
8. 4.   
De m o gra p hic a n d Baseli ne C haracteristics A nal ysis.............................................................................. 8 0
8. 5.  
Efficac y A nal ysis..................................................................................................................................... 8 0
8. 5. 1.  
Pri mar y Efficac y E n d p oi nt A nal ysis..................................................................................... 8 0
8. 5. 2.  
Sec o n dar y Efficac y E n d p oi nt A nal yses ................................................................................ 8 0
8. 6.  
Safet y A nal ysis........................................................................................................................................ 8 0
8. 6. 1.  
Pri mar y Safet y E n d p oi nt A nal ysis ........................................................................................ 8 0
8. 6. 2.   
Ot her Safet y A nal ysis............................................................................................................ 8 0
8. 6. 3.  
E xte nt of E x p os ure................................................................................................................ 8 0
8. 6. 4.   
A d verse E ve nts...................................................................................................................... 8 1
8. 6. 5.  
La b orat or y E val uati o ns ......................................................................................................... 8 1
8. 6. 6.   
Ot her Safet y E val uati o ns....................................................................................................... 8 1
8. 7.  
P har mac o ki netic A nal ysis....................................................................................................................... 8 1
8. 8.  
I m m u n o ge nicit y A nal ysis........................................................................................................................ 8 2
8. 9.  
Bi o mar ker A nal ysis................................................................................................................................. 8 2
8. 1 0.  
Sa m ple Size............................................................................................................................................. 8 2
9.  
R E S P O N SI BI LI TI E S........................................................................................................................................... 8 3
9. 1.  
I n vesti gat or Res p o nsi bilities ................................................................................................................... 8 3
9. 1. 1.   
G o o d Cli nical Practice........................................................................................................... 8 3
9. 1. 2.  
Fi na ncial Discl os ure.............................................................................................................. 8 3
9. 1. 3.  
I nstit uti o nal Re vie w B oar d/I n de pe n de nt Et hics C o m mittee Re vie w a n d 
A p pr o val................................................................................................................................ 8 3
9. 1. 4.  
I nf or me d C o nse nt.................................................................................................................. 8 3
9. 1. 5.  
C o nfi de ntialit y....................................................................................................................... 8 4

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 6
2 4 Oct o ber 2 0 2 3
9. 1. 6.  
St u d y Files a n d Rete nti o n of Rec or ds................................................................................... 8 4
9. 1. 7.  
Case Re p ort F or ms................................................................................................................ 8 5
9. 1. 8.  
I n vesti gat or I ns pecti o ns......................................................................................................... 8 6
9. 1. 9.  
Pr ot oc ol C o m plia nce............................................................................................................. 8 6
9. 2.  
S p o ns or Res p o nsi bilities ......................................................................................................................... 8 6
9. 2. 1.  
Pr ot oc ol M o dificati o ns.......................................................................................................... 8 6
9. 2. 2.  
St u d y Re p ort a n d P u blicati o ns .............................................................................................. 8 6
9. 3.  
J oi nt I n vesti gat or/ S p o ns or Res p o nsi bilities ............................................................................................ 8 7
9. 3. 1.  
Pa y me nt Re p orti n g................................................................................................................ 8 7
9. 3. 2.   
Access t o I nf or mati o n f or M o nit ori n g................................................................................... 8 7
9. 3. 3.   
Access t o I nf or mati o n f or A u diti n g or I ns pecti o ns............................................................... 8 7
9. 3. 4.  
St u d y Disc o nti n uati o n........................................................................................................... 8 7
1 0. 
R E F E R E N C E S..................................................................................................................................................... 8 8
1 1. 
A P P E N DI C E S...................................................................................................................................................... 9 2
A p pe n di x 1.  
I n vesti gat or Si g nat ure Pa ge..................................................................................................... 9 3
A p pe n di x 2.   
Mar keti n g A ut h orizati o n Stat us of St u d y I nter ve nti o ns.......................................................... 9 4
A p pe n di x 3.  
Sc he d ules of Assess me nt......................................................................................................... 9 5
A p pe n di x 4.  
Pa n de mic Ris k Assess me nt a n d Miti gati o n Pla n .................................................................. 1 0 2
A p pe n di x 5.  
T o xicit y Gra di n g Scale f or Se verit y of A d verse E ve nts a n d La b orat or y 
A b n or malities ........................................................................................................................ 1 0 6
A p pe n di x 6.  
Pre g na nc y Preca uti o ns, Defi niti o n f or Fe male of C hil d beari n g P ote ntial, a n d 
C o ntrace pti ve Re q uire me nts.................................................................................................. 1 0 7
A p pe n di x 7.  
Easter n C o o perati ve O nc ol o g y Gr o u p ( E C O G) Perf or ma nce Stat us.................................... 1 1 0
A p pe n di x 8.  
Res p o nse E val uati o n Criteria i n S oli d T u m ors ( R E CI S T, Versi o n 1. 1)............................... 1 1 1
A p pe n di x 9.  
C o u ntr y- S pecific Re q uire me nts ............................................................................................ 1 1 2
A p pe n di x 1 0.   
A me n d me nt Hist or y .............................................................................................................. 1 1 3
LI S T O F I N- T E X T T A B L E S
Ta ble 1.   
G S- U S- 5 4 8- 5 9 1 8: St u d y O bjecti ves a n d E n d p oi nts ............................................................... 3 3
Ta ble 2.  
Safet y R u n-i n C o h ort 1: D ose Le vel, Sc he d ule, a n d De-escalati o n........................................ 3 8
Ta ble 3.  
P hase 2 C o h ort 1: D ose Le vel a n d Sc he d ule........................................................................... 3 8
Ta ble 4.  
Re pri mi n g G ui deli nes f or Ma gr oli ma b ................................................................................... 5 0
Ta ble 5.   
Ma gr oli ma b D osi n g G ui da nce f or Pla n ne d S ur gical Pr oce d ures o n St u d y............................. 5 1
Ta ble 6.   
D oceta xel D ose M o dificati o ns f or Ne utr o pe nia...................................................................... 5 3
Ta ble 7.   
D oceta xel D ose Re d ucti o ns f or He patic T o xicit y................................................................... 5 4
Ta ble 8.   
D oceta xel D ose M o dificati o ns f or Ot her Gra de 3/ 4 T o xicities............................................... 5 5
Ta ble 9.  
Scree ni n g La b orat or y A nal ytes............................................................................................... 5 9
Ta ble 1 0.  
St u d y La b orat or y A nal ytes...................................................................................................... 6 0
Ta ble 1 1.   
Ma na ge me nt of I nf usi o n-relate d Reacti o ns............................................................................. 7 4
Ta ble 1 2.  
P ne u m o nitis Ma na ge me nt Al g orit h m...................................................................................... 7 6
Ta ble 1 3.  
Sa m ple Size Calc ulati o ns ........................................................................................................ 8 2
LI S T O F I N- T E X T FI G U R E S
Fi g ure 1.  
Effect of Ma gr oli ma b o n A ne mia a n d Miti gati o n wit h a Pri mi n g/ Mai nte na nce 
D osi n g Re gi me n...................................................................................................................... 2 7
Fi g ure 2.  
St u d y Sc he ma.......................................................................................................................... 3 4

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 7
2 4 Oct o ber 2 0 2 3
P R O T O C O L S Y N O P SI S
Gile a d Scie nces, I nc.
3 3 3 L a kesi de Dri ve
F oster Cit y, C A 9 4 4 0 4
St u d y Title:  
A P hase 2, M ulti- Ar m St u d y of Ma gr oli ma b i n Patie nts wit h S oli d T u m ors
Pl ai n L a n g u a ge 
S h ort Title:
St u d y of Ma gr oli ma b i n Patie nts Wit h S oli d T u m ors
I N D N u m ber:
E u dr a C T 
N u m ber:
Cli nic al 
Tri als. g o v 
I de ntifier:
1 1 7 6 8 7
2 0 2 0- 0 0 5 2 6 5- 1 4
N C T 0 4 8 2 7 5 7 6
St u d y Ce nters 
Pl a n ne d:
A p pr o xi matel y 5 0 ce nters gl o ball y
O bjecti ves a n d 
E n d p oi nts:
Pri m ar y O bjecti ves
Pri m ar y E n d p oi nts
• 
T o e val uate t he safet y, t olera bilit y, 
a n d rec o m me n de d P hase 2 d ose of 
ma gr oli ma b + d oceta xel 
c o m bi nati o n t hera p y i n s oli d 
t u m ors ( Safet y R u n-i n C o h ort 1, 
P hase 2 C o h orts 1a, 1 b, a n d 1c)
• 
T o e val uate t he efficac y of 
ma gr oli ma b + d oceta xel 
c o m bi nati o n t hera p y i n s oli d 
t u m ors as deter mi ne d b y 
i n vesti gat or-assesse d o bjecti ve 
res p o nse rate ( O R R) ( P hase 2 
C o h orts 1a, 1 b, a n d 1c)
• 
I nci de nce of a d verse e ve nts ( A Es) a n d 
la b orat or y a b n or malities acc or di n g t o t he 
Nati o nal Ca ncer I nstit ute ( N CI) C o m m o n 
Ter mi n ol o g y Criteria f or A d verse E ve nts 
( C T C A E), Versi o n 5. 0 (A p pe n di x 5 ; 
Safet y R u n-i n C o h ort 1, P hase 2 
C o h orts 1a, 1 b, a n d 1c)
• 
O R R, defi ne d as t he pr o p orti o n of patie nts 
w h o ac hie ve a c o m plete res p o nse or 
partial res p o nse, as meas ure d b y Res p o nse 
E val uati o n Criteria i n S oli d T u m ors 
( R E CI S T), Versi o n 1. 1, as deter mi ne d b y 
i n vesti gat or assess me nt ( P hase 2 
C o h orts 1a, 1 b, a n d 1c)
Sec o n d ar y O bjecti ve s
Sec o n d ar y E n d p oi nts
• 
T o e val uate pr o gressi o n-free 
s ur vi val ( P F S) b y i n vesti gat or 
assess me nt ( P hase 2 C o h orts 1a, 
1 b, a n d 1c)
• 
T o e val uate a d diti o nal meas ures of 
efficac y of ma gr oli ma b + 
d oceta xel c o m bi nati o n t hera p y, 
i ncl u di n g d urati o n of res p o nse 
( D O R) a n d o verall s ur vi val ( O S) 
( P hase 2 C o h orts 1a, 1 b, a n d 1c)
• 
P F S fr o m date of d ose i nitiati o n as 
deter m i ne d b y i n vesti gat or assess me nt 
per R E CI S T, Versi o n 1. 1 ( P hase 2 
C o h orts 1a, 1 b, a n d 1c)
• 
D O R, defi ne d as ti me fr o m first 
d oc u me ntati o n of c o m plete res p o nse or 
partial res p o nse t o t he earliest date of 
d oc u me nte d disease pr o gressi o n, per 
R E CI S T, Versi o n 1. 1, or deat h fr o m a n y 
ca use, w hic he ver occ urs first, as 

M a gr oli m a b 
Gil e a d  S ci e n c e s , I n c. 
St u d y D e si g n: 
C O N FI D E N TI A L 
• 
T o  e v al u at e  th e  p h a 1 m a c o ki n eti cs 
( P K) a n d  illllll u n o g e ni cit y of 
m a gr oli m a b  w h e n  gi v e n  wit h 
d o c et a x el  as  a  c o m bi n ati o n  t h er a p y 
( S af et y R u n -i n C o h ort  1,  P h a s e  2 
C o h orts l a, l b, a n d l e) 
• 
• 
Pr o to c ol  G S -U S - 5 4 8- 5 9 1 8 
A m e n d m e nt s 
d et e 1 mi n e d  b y  i n v esti g ator  ass ess m e nt 
( P h as e 2 C o h o 1is l a, l b, a n d l e) 
O S , d efi n e d  a s d a t e of d o s e  i niti ati o n 
( P h as e 2  C o h o 1is l a, l b, a n d l e) t o d e a t h 
fr o m a n y  c a us e . 
M a gr oli m a b  c o n c e ntr ati o n v ers us  ti m e 
a n d a nti dt u g  a nti b o di es  t o m a gr oli m a b 
(S af et y  R u n -i n C o h o 1t  1;  P h a s e  2 
C o h o 1ts l a, l b, a n d l e) 
T hi s  P h a s e  2,  o p e n -l a b el, m ulti c e nt er , m ulti- a n n  st u d y i s e v al u ati n g 
m a gr oli m a b  +  d o c et a x el  c o m bi n ati o n  t h er a p y f or p ati e nts  wit h  s o li d t u m ors. 
T hi s  stu d y  will  c o nsi st of t h e f oll o wi n g S af et y  R u n-i n  C o h o 1t: 
•  S af et y  R u n-i n  C o h o rt 1: m a gr oli m a b  +  d o c et a x el  c o m b i nati o n  i n 
p ati e nts  wit h  s oli d t u m or s ( m et ast ati c n o n- sm all  c e ll l u n g c a n c e r 
[ m N S C L C] , m et ast ati c  ur ot h eli al  c a n c e r  [ m U C] , a n d m et ast ati c  sm all 
c e ll l u n g c a n c e r  [ m S C L C]) 
Aft e r c o m pl eti o n of S af et y  R u n-i n  C o h o rt 1,  P h as e  2  C o h o 1i  1  w ill o c c ur  as 
f oll o ws: 
•  P h a s e  2  C o h o rt 1: a  c o h o 1i of p ati e nts  wit h  s o li d t u m ors  (m N S C L C 
[P h as e  2  C o h o 1i  l a] , m U C  [ P h as e 2  C o h o 1i  l b], a n d m S C L C  [ P h as e 2 
C o h o 1i  l e]) 
T h e  st u d y s c h e m ati c i s pr o v i de d b el o w. 
S af et y R u n- i n C o h ort 1 
m N S C L C, m u c ,    mS C L C 
M a gr o lim a b + 
D o c et a x e l 
N  =  1 8 
S af et y E v al u ati o n a n d R P 2 D 
P h a s e 2 C o h ort  1 
( M a gr olim a b + D o c et a x e l ) 
P h a s e  2 C o h ort l a 
( m N S C LC) 
N  = 3 0 
P h a s e  2  C o h ort l b 
( m U C) 
N  =  2 6 
P h a s e  2 C o h ort l e 
( m S C L C) 
N  = 4 0 
m N S C L C = m et ast ati c  n o n- s m all  c ell  l u n g c a n c er ; m S C L C = m et ast ati c  s m a ll c ell  l u n g c a n c er ; 
m U C = m et a s t ati c ur ot h eli al  c a n c er ; R P 2 D = r e c o m m e n d e d P h a s e  2  d o s e 
P a g e 8 
2 4  O c to b er  2 0 2 3 

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 9
2 4 Oct o ber 2 0 2 3
S afet y R u n-i n C o h ort 1 : 
A d ose ‑li miti n g t o xicit y ( D L T) e val uati o n peri o d of 1 c ycle ( 2 1 da ys) will 
occ ur. After 6 patie nts ha ve c o m plete d t he D L T e val uati o n peri o d, a 
decisi o n will be ma de o n f urt her e x pa nsi o n or d ose de-escalati o n. 
E ve n t h o u g h n o d ose- de pe n de nt t o xicities ha ve bee n o bser ve d wit h 
ma gr oli ma b, i n or der t o preser ve t he efficaci o us d oses of t he c o m bi nati o n 
part ner dr u gs, d ose de-escalati o n will ta ke place f or ma gr oli ma b.
D ose de-escalati o n decisi o ns will be ma de as f oll o ws:
•
If 2 or fe wer of 6 D L T-e val ua ble patie nts e x perie nce a D L T i n C ycle 1, 
e nr oll me nt i nt o P hase 2 C o h ort 1 will be gi n at t his d ose le vel as t he 
rec o m me n de d P hase 2 d ose.
•
If m ore t ha n 2 patie nts e x perie nce at least 1 D L T d uri n g C ycle 1, 
e nr oll me nt at t he c urre nt d ose le vel will i m me diatel y st o p a n d d ose 
de-escalati o n will occ ur. U p t o a n ot her 6 patie nts will t he n be e nr olle d 
a n d e val uate d at a l o wer d ose le vel i n t he sa me ma n ner.
U p t o a p pr o xi matel y 1 8 patie nts c o ul d be p ote ntiall y e nr olle d a n d e val uate d 
d uri n g t he Safet y R u n-i n C o h ort.
D L T Assess me nt Peri o d:  T he D L T assess me nt peri o d will be t he first 
c ycle ( 2 1 da ys) a n d a p plies t o Safet y R u n-i n C o h ort 1. Patie nts are 
c o nsi dere d e val ua ble f or assess me nt of a D L T if eit her of t he f oll o wi n g 
criteria are met i n t he D L T assess me nt peri o d:
•
T he patie nt e x perie nce d a D L T at a n y ti me after i nitiati o n of t he first 
i nf usi o n of ma gr oli ma b.
•
T he patie nt di d n ot e x perie nce a D L T a n d c o m plete d at least 2 i nf usi o ns 
of ma gr oli ma b ( 2 1- da y c ycle) a n d at least 1 d ose of d oceta xel i n Safet y 
R u n-i n C o h ort 1.
If a patie nt e x perie nces a D L T d uri n g t he D L T assess me nt peri o d, t he 
patie nt will disc o nti n ue treat me nt.
Patie nts w h o are n ot e val ua ble f or D L T assess me nt i n t he Safet y R u n-i n 
C o h ort 1 will be re place d.
T he D L T defi niti o n is pr o vi de d i n t he mai n pr ot oc ol ( Secti o n 3. 1. 1. 2 ).
P h ase 2 C o h ort 1:  O nce Safet y R u n-i n C o h ort 1 is c o m plete d a n d t he 
rec o m me n de d d ose f or P hase 2 C o h ort 1 is deter mi ne d, t he s p o ns or will 
o pe n P hase 2 C o h ort 1. P hase 2 C o h ort 1 will treat u p t o 3 0 patie nts wit h 
m N S C L C ( P hase 2 C o h ort 1a), u p t o 2 6 patie nts wit h m U C ( P hase 2 
C o h ort 1 b), a n d u p t o 4 0 patie nts wit h m S C L C ( P hase 2 C o h ort 1c) t o 
e val uate efficac y.
N u m ber of 
P atie nts 
Pl a n ne d:
U p t o a p pr o xi matel y 1 1 4 patie nts i n t otal
•
Safet y R u n-i n C o h ort 1: u p t o a p pr o xi matel y 1 8 patie nts
•
P hase 2 C o h ort 1: u p t o a p pr o xi matel y 9 6 patie nts

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 0
2 4 Oct o ber 2 0 2 3
T ar get 
P o p ul ati o n:
P h ase 2 C o h ort 1:  Patie nts wit h m N S C L C, m U C, a n d m S C L C 
D ur ati o n of 
Tre at me nt:
C ycle le n gt hs are 2 1 da ys f or t he Safet y R u n-i n C o h ort 1 a n d P hase 2 
C o h ort 1. All patie nts will c o nti n ue st u d y treat me nt u nless t he y meet st u d y 
treat me nt disc o nti n uati o n criteria.
Di a g n osis a n d 
M ai n Eli gi bilit y 
Criteri a:
I ncl usi o n Criteri a:
All patie nts m ust meet all of t he f oll o wi n g i ncl usi o n criteria t o be eli gi ble 
f or partici pati o n i n t his st u d y:
1)
Patie nt has pr o vi de d i nf or me d c o nse nt.
2)
Patie nt is willi n g a n d a ble t o c o m pl y wit h cli nic visits a n d pr oce d ures 
o utli ne d i n t he st u d y pr ot oc ol.
3)
Male or fe male, ≥ 1 8 years of a ge
4)
Patie nts m ust ha ve a n Easter n C o o perati ve O nc ol o g y Gr o u p ( E C O G) 
perf or ma nce stat us of ≤ 2.
5)
La b orat or y meas ure me nts, bl o o d c o u nts:
a)
He m o gl o bi n m ust be ≥ 9 g/ d L pri or t o i nitial d ose of st u d y dr u g. 
N O T E: Tra nsf usi o ns are all o we d t o meet eli gi bilit y (see 
Secti o n 7. 8. 1. 1. 1  i n t he cli nical pr ot oc ol a n d e xcl usi o n criteri o n 4)
b)
A bs ol ute ne utr o p hil c o u nt ≥ 1. 5  1 09/ L
c)
Platelets ≥ 1 0 0  1 09/ L
6)
La b orat or y meas ure me nts, re nal f u ncti o n:
a)
Patie nts m ust ha ve a de q uate re nal f u ncti o n as de m o nstrate d b y a 
creati ni ne cleara nce of at least 3 0 m L/ mi n; calc ulate d b y t he 
C oc kcr oft Ga ult f or m ula
7)
A de q uate li ver f u ncti o n, as de m o nstrate d b y:
a)
A S T less t ha n or e q ual t o 2. 5  u p per li mit of n or mal ( U L N) or less 
t ha n or e q ual t o 5  U L N i n patie nts wit h li ver metastases 
b)
A L T less t ha n or e q ual t o 2. 5  U L N or less t ha n or e q ual t o 
5  U L N i n patie nts wit h li ver metastases
c)
Bilir u bi n less t ha n or e q ual t o 1. 5  U L N, or less t ha n or e q ual 
t o 3. 0  U L N a n d pri maril y u nc o nj u gate d if patie nt has a 
d oc u me nte d hist or y of Gil bert’s s y n dr o me or ge netic e q ui vale nt
8)
Pretreat me nt bl o o d cr oss- matc h c o m plete d ( See Secti o n 7. 8. 1. 1. 1  i n t he 
cli nical pr ot oc ol)

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 1
2 4 Oct o ber 2 0 2 3
9) 
Male a n d fe male patie nts of c hil d beari n g p ote ntial w h o e n ga ge i n 
heter ose x ual i nterc o urse m ust a gree t o use pr ot oc ol-s pecifie d met h o d(s) 
of c o ntrace pti o n as descri be d i n A p pe n di x 6 .
1 0) Meas ura ble disease acc or di n g t o R E CI S T, Versi o n 1. 1. Pre vi o usl y 
irra diate d lesi o ns ca n be c o nsi dere d as meas ura ble disease o nl y if 
disease pr o gressi o n has bee n u ne q ui v ocall y d oc u me nte d at t hat site 
si nce ra diati o n.
1 1) Criteri o n re m o ve d.
C o h ort- S pecific I ncl usi o n Criteri a
Patie nts nee d t o f ulfill t he f oll o wi n g c o h ort-s pecific criteria, i n a d diti o n t o 
satisf yi n g t he i ncl usi o n criteria f or all patie nts:
1 2) Criteri o n re m o ve d.
1 3) Criteri o n re m o ve d.
1 4) Safet y R u n-i n C o h ort 1: Patie nts wit h metastatic a d va nce d s oli d t u m ors 
w h o ha ve ha d at least 1 pri or li ne of s yste mic a ntica ncer t hera p y 
( m N S C L C a n d m S C L C) i n a l ocall y a d va nce d/ metastatic setti n g, or 
2 pri or li nes of s yste mic a ntica ncer t hera p y ( m U C) i n a l ocall y 
a d va nce d/ metastatic setti n g, a n d n ot m ore t ha n 3 pri or li nes of s yste mic 
a ntica ncer t hera p y i n a l ocall y a d va nce d/ metastatic setti n g.
1 5) P hase 2 C o h ort 1a ( m N S C L C): Patie nts wit h N S C L C w h o ha ve ha d 
treat me nt wit h plati n u m- base d c he m ot hera p y a n d i m m u ne c hec k p oi nt 
i n hi bit or t hera p y i n a l ocall y a d va nce d/ metastatic setti n g, eit her i n 
c o m bi nati o n or se q ue ntiall y ( u nless n ot eli gi ble f or o ne of t hese 
t hera pies) are eli gi ble. At least 1 pri or li ne of s yste mic a ntica ncer 
t hera p y i n a l ocall y a d va nce d/ metastatic setti n g is re q uire d a n d n ot 
m ore t ha n 2 pri or li nes of s yste mic a ntica ncer t hera p y i n a l ocall y 
a d va nce d/ metastatic setti n g are all o we d. Patie nts treate d wit h a ta xa ne 
wit hi n 1 2 m o nt hs or patie nts refract or y t o pri or ta xa ne treat me nt are 
e xcl u de d. Patie nts w h ose t u m ors ha ve ge n o mic alterati o ns f or w hic h 
t here are a p pr o ve d t hera pies (e g, E G F R, R O S 1, A L K, N T R K, M E T 
e x o n 1 4) are e xcl u de d.
1 6) P hase 2 C o h ort 1 b ( m U C): Patie nts wit h U C w h o ha ve ha d pri or 
treat me nt wit h s yste mic c he m ot hera p y a n d i m m u ne c hec k p oi nt 
i n hi bit or t hera p y i n a l ocall y a d va nce d/ metastatic setti n g ( u nless n ot 
eli gi ble f or o ne of t hese t hera pies) are eli gi ble. At least 2 pri or li nes of 
s yste mic a ntica ncer t hera p y i n a l ocall y a d va nce d/ metastatic setti n g are 
re q uire d a n d n ot m ore t ha n 3 pri or li nes of s yste mic a ntica ncer t hera p y 
i n a l ocall y a d va nce d/ metastatic setti n g are all o we d. Patie nts treate d 
wit h a ta xa ne wit hi n 1 2 m o nt hs or patie nts refract or y t o pri or ta xa ne 
treat me nt are e xcl u de d.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 2
2 4 Oct o ber 2 0 2 3
1 7) P hase 2 C o h ort 1c ( m S C L C): Patie nts wit h S C L C w h o ha ve ha d pri or 
treat me nt wit h plati n u m- base d c he m ot hera p y wit h or wit h o ut 
i m m u n ot hera p y are eli gi ble. At least 1 pri or li ne of s yste mic a ntica ncer 
t hera p y i n a l ocall y a d va nce d/ metastatic setti n g is re q uire d a n d n ot 
m ore t ha n 2 pri or li nes of s yste mic a ntica ncer t hera p y i n a l ocall y 
a d va nce d/ metastatic setti n g are all o we d. Patie nts treate d wit h a ta xa ne 
wit hi n 1 2 m o nt hs or patie nts refract or y t o pri or ta xa ne treat me nt are 
e xcl u de d.
N ote: Mai nte na nce t hera pies are n ot c o u nte d as se parate li nes of t hera p y.
E xcl usi o n Criteri a:
Patie nts w h o meet a ny  of t he f oll o wi n g e xcl usi o n criteria are n ot t o be 
e nr olle d i n t his st u d y:
1)
P ositi ve ser u m pre g na nc y test
2)
Breastfee di n g fe male
3)
Acti ve ce ntral ner v o us s yste m ( C N S) disease. Patie nts wit h 
as y m pt o matic a n d sta ble, treate d C N S lesi o ns (ra diati o n a n d/ or s ur ger y 
a n d/ or ot her C N S- directe d t hera p y w h o ha ve n ot recei ve d 
c ortic oster oi ds f or at least 4 wee ks) are all o we d.
4)
Re d bl o o d cell ( R B C) tra nsf usi o n de pe n de nce, defi ne d as re q uiri n g 
m ore t ha n 2 u nits of pac ke d re d bl o o d cell tra nsf usi o ns d uri n g t he 
4- wee k peri o d pri or t o scree ni n g. R B C tra nsf usi o ns are per mitte d 
d uri n g t he scree ni n g peri o d a n d pri or t o e nr oll me nt t o meet t he 
he m o gl o bi n i ncl usi o n criteria.
5)
Hist or y of he m ol ytic a ne mia, a ut oi m m u ne t hr o m b oc yt o pe nia, or E va ns 
s y n dr o me i n t he last 3 m o nt hs
6)
K n o w n h y perse nsiti vit y t o a n y of t he st u d y dr u gs, t he meta b olites, or 
f or m ulati o n e xci pie nt
7)
Pri or treat me nt wit h C D 4 7- or si g nal re g ulat or y pr otei n al p ha-tar geti n g 
a ge nts
8)
C urre nt partici pati o n i n a n ot her i nter ve nti o nal cli nical trial
9)
K n o w n i n herite d or ac q uire d blee di n g dis or ders
1 0) Si g nifica nt disease or me dical c o n diti o ns, as assesse d b y t he i n vesti gat or 
a n d s p o ns or, t hat w o ul d s u bsta ntiall y i ncrease t he ris k- be nefit rati o of 
partici pati n g i n t he st u d y. T his i ncl u des, b ut is n ot li mite d t o, ac ute 
m y ocar dial i nfarcti o n wit hi n t he last 6 m o nt hs, u nsta ble a n gi na, 
u nc o ntr olle d dia betes mellit us, si g nifica nt acti ve i nfecti o ns, a n d c o n gesti ve 
heart fail ure Ne w Y or k Heart Ass ociati o n Class III-I V.
1 1) Sec o n d mali g na nc y, e xce pt treate d basal cell or l ocalize d  s q ua m o us 
s ki n carci n o mas, l ocalize d pr ostate ca ncer, or ot her mali g na ncies f or 
w hic h patie nts are n ot o n acti ve a ntica ncer t hera pies a n d w h o are i n 
c o m plete re missi o n f or o ver 3 years.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 3
2 4 Oct o ber 2 0 2 3
1 2) K n o w n acti ve or c hr o nic he patitis B or C i nfecti o n or h u ma n 
i m m u n o deficie nc y vir us i nfecti o n i n me dical hist or y.
1 3) Pri or a ntica ncer t hera p y i ncl u di n g b ut n ot li mite d t o c he m ot hera p y, 
i m m u n ot hera p y, or i n vesti gati o nal a ge nts wit hi n 4 wee ks pri or t o 
ma gr oli ma b is n ot per mitte d.
N O T E: Palliati ve, l ocalize d, n o n- C N S ra di ot hera p y t o areas of 
n o n-tar get disease, pre vi o us h or m o nal t hera p y wit h l utei nizi n g h or m o ne 
releasi n g h or m o ne a g o nists f or pr ostate or breast ca ncer, a n d treat me nt 
wit h bis p h os p h o nates a n d rece pt or acti vat or of n uclear fact or ka p pa B 
li ga n d ( R A N K L) i n hi bit ors are n ot criteria f or e xcl usi o n. T here is n o 
re q uire d mi ni m u m was h o ut peri o d f or t hese t hera pies. Patie nts s h o ul d 
be rec o vere d fr o m t he effects of ra diati o n.
St u d y 
Pr oce d ures/
Fre q ue nc y:
I n Safet y R u n-i n C o h ort 1, eli gi ble patie nts will recei ve ma gr oli ma b + 
d oceta xel. T he st u d y treat me nts are s h o w n bel o w.
S afet y R u n-i n C o h ort 1: D ose Le vel, Sc he d ule, a n d De-esc al ati o n 
D osi n g ( C ycles Are 2 1 D a ys)
Dr u g
D ose Le vel 
C ycle 1
C ycle 2
C ycle 3 + 
( m ai nte n a nce 
d osi n g)
Starti n g 
d ose
3 0 m g/ k g
1 m g/ k g I V ( 3 h 
± 3 0 mi n) o n 
Da y 1 ( pri mi n g 
d ose), 3 0 m g/ k g 
I V ( 2 h ± 3 0 mi n) 
o n Da ys 8 a n d 1 5
3 0 m g/ k g I V 
( 2 h ± 3 0 mi n) 
o n Da ys 1, 8, 
a n d 1 5
6 0 m g/ k g I V 
( 2 h ± 3 0 mi n) 
o n Da y 1
De-escalati o
n
Le vel −1
2 0 m g/ k g
1 m g/ k g I V ( 3 h 
± 3 0 mi n) o n 
Da y 1 ( pri mi n g 
d ose); 2 0 m g/ k g 
I V ( 2 h ± 3 0 mi n) 
o n Da ys 8 a n d 1 5
2 0 m g/ k g I V 
( 2 h ± 3 0 mi n) 
o n Da ys 1, 8, 
a n d 1 5
4 5 m g/ k g I V 
( 2 h ± 3 0 mi n) 
o n Da y 1
Ma gr oli ma b
De-escalati o
n
Le vel −2
1 5 m g/ k g
1 m g/ k g I V ( 3 h 
± 3 0 mi n) o n 
Da y 1 ( pri mi n g 
d ose); 1 5 m g/ k g 
I V ( 2 h ± 3 0 mi n) 
o n Da ys 8 a n d 1 5
1 5 m g/ k g I V 
( 2 h ± 3 0 mi n) 
o n Da ys 1, 8, 
a n d 1 5
3 0 m g/ k g I V 
( 2 h ± 3 0 mi n) 
o n Da y 1
D oceta xel 
7 5 m g/ m 2
7 5 m g/ m 2 I V ( 1 h 
± 5 mi n) o n Da y 
1
7 5 m g/ m 2 I V 
( 1 h ± 5 mi n) 
o n Da y 1
7 5 m g/ m 2 I V 
( 1 h ± 5 mi n) 
o n Da y 1
I V = i ntra ve n o us

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 4
2 4 Oct o ber 2 0 2 3
P h ase 2 C o h ort 1: D ose Le vel a n d Sc he d ule 
D ose Sc he d ule ( C ycles Are 2 1 D a ys)
Dr u g
R P 2 D a
St arti n g 
D ose
C ycle 1
C ycle 2
C ycle 3 + 
( m ai nte n a nce 
d osi n g)
3 0 m g/ k g 
1 m g/ k g I V 
( 3 h ± 3 0 mi n) o n 
Da y 1 ( pri mi n g 
d ose); 3 0 m g/ k g 
I V ( 2 h ± 3 0 mi n) 
o n Da ys 8 a n d 1 5
3 0 m g/ k g I V 
( 2 h ± 3 0 mi n) 
o n Da ys 1, 8, 
a n d 1 5
6 0 m g/ k g I V 
( 2 h ± 3 0 mi n) 
o n Da y 1
O R
2 0 m g/ k g
1 m g/ k g I V 
( 3 h ± 3 0 mi n) o n 
Da y 1 ( pri mi n g 
d ose); 2 0 m g/ k g 
I V ( 2 h ± 3 0 mi n) 
o n Da ys 8 a n d 1 5
2 0 m g/ k g I V 
( 2 h ± 3 0 mi n) 
o n Da ys 1, 8, 
a n d 1 5
4 5 m g/ k g I V 
( 2 h ± 3 0 mi n) 
o n Da y 1
Ma gr oli ma b
O R
1 5 m g/ k g
1 m g/ k g I V 
( 3 h ± 3 0 mi n) o n 
Da y 1 ( pri mi n g 
d ose); 1 5 m g/ k g 
I V ( 2 h ± 3 0 mi n) 
o n Da ys 8 a n d 1 5
1 5 m g/ k g I V 
( 2 h ± 3 0 mi n) 
o n Da ys 1, 8, 
a n d 1 5
3 0 m g/ k g I V 
( 2 h ± 3 0 mi n) 
o n Da y 1
D oceta xel 
7 5 m g/ m 2 
I V
7 5 m g/ m 2 I V 
( 1 h ± 5 mi n) o n 
Da y 1
7 5 m g/ m 2 I V 
( 1 h ± 5 mi n) o n 
Da y 1
7 5 m g/ m 2 I V 
( 1 h ± 5 mi n) o n 
Da y 1
I V = i ntra ve n o us; R P 2 D = rec o m me n de d P hase 2 d ose
a  
R P 2 D as deter mi ne d i n Safet y R u n-i n C o h ort 1.
C ycle le n gt hs are 2 1 da ys f or Safet y R u n-i n C o h ort 1 a n d P hase 2 C o h ort 1. 
Patie nts ma y c o nti n ue treat me nt u nless t he y de vel o p u nacce pta ble t o xicit y 
t hat ca n n ot be cli nicall y ma na ge d b y d ose or sc he d ule m o dificati o ns or if 
t he y ha ve c o nfir me d pr o gressi ve disease acc or di n g t o R E CI S T, Versi o n 1. 1.
Test Pr o d uct, 
D ose, a n d M o de 
of 
A d mi nistr ati o n:
Safet y R u n-i n C o h ort 1 D oses:
•
Ma gr oli ma b 1 m g/ k g I V ( pri mi n g)
•
Ma gr oli ma b 3 0 m g/ k g I V
•
Ma gr oli ma b 6 0 m g/ k g I V
I n c o m bi nati o n wit h d oceta xel 7 5 m g/ m2 I V
P hase 2 C o h ort 1:
Ma gr oli ma b d ose will be deter mi ne d i n Safet y R u n-i n C o h ort 1.
Refere nce 
T her a p y, D ose, 
a n d M o de of 
A d mi nistr ati o n:
N ot a p plica ble

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 5
2 4 Oct o ber 2 0 2 3
Criteri a f or 
E v al u ati o n:
Safet y: 
Safet y will be e val uate d b y data i ncl u di n g t he i nci de nce of a d verse e ve nts 
( A Es) f or t he d urati o n of t he st u d y, assess me nt of cli nical la b orat or y test 
fi n di n gs, p h ysical e xa mi nati o n, 1 2-lea d electr ocar di o gra m, E C O G 
perf or ma nce stat us, a n d vital si g ns meas ure me nts. A d verse e ve nts will be 
gra de d usi n g N CI C T C A E, Versi o n 5. 0.
Efficac y: 
Efficac y will be e val uate d b y P F S, O R R, D O R, a n d O S. Assess me nt of 
res p o nse will be meas ure d b y R E CI S T, Versi o n 1. 1 as deter mi ne d b y 
i n vesti gat or assess me nt.
P har mac o ki netics:
Ma gr oli ma b ser u m dr u g c o nce ntrati o ns will be assesse d at pre d ose at 
m ulti ple ti me p oi nts u ntil st u d y disc o nti n uati o n. Peri p heral bl o o d f or 
i m m u n o ge nicit y assess me nts f or a nti dr u g a nti b o dies a gai nst ma gr oli ma b 
will als o be c ollecte d at pre d ose a n d m ulti ple ti me p oi nts d uri n g t he st u d y.
St atistic al 
Met h o ds:
A nal ysis Data Sets
T he D L T E val ua ble A nal ysis Set f or Safet y R u n-i n C o h ort 1 will i ncl u de all 
patie nts w h o meet 1 of t he f oll o wi n g criteria i n t he D L T e val ua ble peri o d:
•
T he patie nt e x perie nce d a D L T at a n y ti me after i nitiati o n of t he first 
i nf usi o n of ma gr oli ma b
•
T he patie nt di d n ot e x perie nce a D L T a n d c o m plete d at least 2 i nf usi o ns 
of ma gr oli ma b ( 2 1- da y c ycle) a n d at least 1 d ose of d oceta xel i n Safet y 
R u n-i n C o h ort 1
F or Safet y R u n-i n C o h ort 1, t he m o difie d I nte nt-t o- Treat (I T T) a n d Safet y 
A nal ysis Sets will i ncl u de all patie nts w h o recei ve d at least 1 d ose of a n y 
st u d y dr u g.
F or P hase 2 C o h ort 1, t he m o difie d I T T A nal ysis Set a n d t he Safet y 
A nal ysis Set will i ncl u de all patie nts w h o recei ve d at least 1 d ose of a n y 
st u d y dr u g.
T he P K A nal ysis Set will i ncl u de all patie nts w h o recei ve d a n y a m o u nt of 
ma gr oli ma b a n d ha ve at least 1 meas ura ble p osttreat me nt ser u m 
c o nce ntrati o n of ma gr oli ma b.
T he I m m u n o ge nicit y A nal ysis Set will i ncl u de all patie nts w h o recei ve d a n y 
a m o u nt of ma gr oli ma b a n d ha d at least 1 e val ua ble a nti- ma gr oli ma b 
a nti b o d y test res ult.
T he Bi o mar ker A nal ysis Set i ncl u des all patie nts w h o recei ve d a n y st u d y 
dr u g a n d ha ve at least 1 e val ua ble bi o mar ker meas ure me nt a vaila ble. T his 
will be t he pri mar y a nal ysis set f or all bi o mar ker data a nal yses.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 6
2 4 Oct o ber 2 0 2 3
D ose Deter mi nati o n A nal ysis
F or t he p ur p oses of ma ki n g t he d ose de-escalati o n decisi o ns f or Safet y 
R u n-i n C o h ort 1, d ose deter mi nati o n a nal yses of rele va nt safet y data 
f oc usi n g o n D L Ts a n d o verall safet y pr ofile will be c o n d ucte d b y t he 
s p o ns or after all patie nts ha ve c o m plete d re q uire d d osi n g c ycles ( 2 1 da ys) 
a n d t he f oll o w- u p peri o d as s pecifie d i n Secti o n 3. 1. 1 . Safet y assess me nts 
(e g, A Es, electr ocar di o gra m, la b orat or y res ults) will be dis pla ye d b y c o h ort 
t o facilitate t he d ose de-escalati o n decisi o ns.
Efficac y A nal ysis
F or P hase 2 C o h ort 1, O R R al o n g wit h t he 9 5 % CI base d o n t he 
Cl o p per- Pears o n met h o d will be esti mate d f or eac h c o h ort ( P hase 2 
C o h orts 1a, 1 b, a n d 1c). Patie nts w h o d o n ot ha ve s ufficie nt baseli ne or 
o n-st u d y t u m or assess me nt t o c haracterize res p o nse will be c o u nte d as 
n o nres p o n ders.
Safet y A nal ysis
Safet y will be assesse d via A Es, cli nical la b orat or y tests, a n d c o nc o mita nt 
me dicati o ns i n t he Safet y A nal ysis Set. I nf or mati o n re gar di n g st u d y dr u g 
a d mi nistrati o n, st u d y dr u g c o m plia nce, a n d ot her safet y varia bles will als o 
be s u m marize d.
Sa m ple Size Calc ulati o n
F or P hase 2 C o h ort 1, a sa m ple size of 3 0 patie nts i n t he m N S C L C c o h ort 
a n d 4 0 patie nts f or m S C L C c o h ort were calc ulate d usi n g o ne sa m ple 
pr o p orti o n test. T he sa m ple size of 2 6 patie nts f or t he m U C c o h ort was 
calc ulate d usi n g e xact met h o d i nstea d of o ne sa m ple test d ue t o s maller 
sa m ple size.
T u m or 
T y pe
S a m ple 
Size 
N ull O R R
Alter n ati ve 
O R R
1-si de d 
al p h a 
P o wer
m N S C L C 
3 0 
1 3 % 
2 5 % 
0. 2 
8 1 %
m U C
2 6 
1 2. 4 % 
2 8 % 
0. 1 
7 8 %
m S C L C
4 0
9 %
2 0 % 
0. 1 5 
8 4 %
T he n ull O R R f or eac h of t he res pecti ve t u m or c o h orts are base d o n 
hist orical ta xa ne efficac y data i n t he sec o n d li ne setti n g. P o wer calc ulati o ns 
were perf or me d usi n g E A S T 6. 5 a n d n Q uer y 8. 0.
T his st u d y will be c o n d ucte d i n acc or da nce wit h t he g ui deli nes of G o o d Cli nical Practice, 
i ncl u di n g arc hi vi n g of esse ntial d oc u me nts.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 7
2 4 Oct o ber 2 0 2 3
G L O S S A R Y O F A B B R E VI A TI O N S A N D D E FI NI TI O N O F T E R M S
A B O
a n y of t he 4 bl o o d gr o u ps A, B, A B, a n d O c o m prisi n g t he A B O s yste m
A D A
a nti dr u g a nti b o d y
A D C
a nti b o d y- dr u g c o nj u gate
A E
a d verse e ve nt
A L T
ala ni ne a mi n otra nsferase
A M L
ac ute m yel oi d le u ke mia
A N C
a bs ol ute ne utr o p hil c o u nt
A S C O
A merica n S ociet y of Cli nical O nc ol o g y
A S T
as partate a mi n otra nsferase
C D 4 7
cl uster of differe ntiati o n 4 7
CI
c o nfi de nce i nter val
C M V
c yt o me gal o vir us
C N S
ce ntral ner v o us s yste m
C O VI D- 1 9
c or o na vir us disease 2 0 1 9
C R
c o m plete res p o nse
C R C
c ol orectal ca ncer
C R F
case re p ort f or m
C R O
c o ntract/cli nical researc h or ga nizati o n
C S R
cli nical st u d y re p ort
C T
c o m p ute d t o m o gra p h y
C T C A E
C o m m o n Ter mi n ol o g y Criteria f or A d verse E ve nts
C Y P
c yt oc hr o me P 4 5 0 e nz y me
D A T
direct a nti gl o b uli n test
D L B C L
diff use lar ge B-cell l y m p h o ma
D L T
d ose-li miti n g t o xicit y
D N A
de o x yri b o n ucleic aci d
D O R
d urati o n of res p o nse
E C
et hic c o m mittee
E C G
electr ocar di o gra m
E C O G
Easter n C o o perati ve O nc ol o g y Gr o u p
e C R F
electr o nic case re p ort f or m
E D C
electr o nic data ca pt ure
E LI S A
e nz y me-li n ke d i m m u n os or be nt assa y
E O T
e n d of treat me nt
E U
E ur o pea n U ni o n
Fc
fra g me nt cr ystalliza ble
F D A
F o o d a n d Dr u g A d mi nistrati o n
G C P
G o o d Cli nical Practice
Gilea d
Gilea d Scie nces

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 8
2 4 Oct o ber 2 0 2 3
H R
hazar d rati o
H U
h y dr o x y urea
I B
i n vesti gat or’s br oc h ure
I C F
i nf or me d c o nse nt f or m
I C H
I nter nati o nal C o u ncil f or Har m o nisati o n ( of Tec h nical Re q uire me nts f or 
P har mace uticals f or H u ma n Use)
I E C
i n de pe n de nt et hics c o m mittee
I g G 4
i m m u n o gl o b uli n G 4
I N D
i n vesti gati o nal ne w dr u g
I R B
i nstit uti o nal re vie w b oar d
I R R
i nf usi o n-relate d reacti o n
I R T
I nteracti ve Res p o nse Tec h n ol o g y
I T T
i nte nt-t o-treat
I U D
i ntra uteri ne de vice
I V
i ntra ve n o us
K D
diss ociati o n c o nsta nt
K M
Ka pla n- Meier
L H R H
l utei nizi n g h or m o ne releasi n g h or m o ne
m A b
m o n ocl o nal a nti b o d y
M D S
m yel o d ys plastic s y n dr o me
Me d D R A
Me dical Dicti o nar y f or Re g ulat or y Acti vities
m N S C L C
metastatic n o n-s mall cell l u n g ca ncer
M O A
mec ha nis m of acti o n
m S C L C
metastatic s mall cell l u n g ca ncer
M T D
ma xi m u m t olerate d d ose
m U C
metastatic ur ot helial ca ncer
na b
na n o particle al b u mi n- b o u n d
N CI
Nati o nal Ca ncer I nstit ute
N H L
n o n- H o d g ki n l y m p h o ma
N S C L C
n o n-s mall cell l u n g ca ncer
O R R
o bjecti ve res p o nse rate
O S
o verall s ur vi val
P B M C
peri p heral bl o o d m o n o n uclear cell
P D
p har mac o d y na mic(s)
P D- 1
pr o gra m me d cell deat h pr otei n 1
P D- L 1
pr o gra m me d cell deat h li ga n d 1
P F S
pr o gressi o n-free s ur vi val
P K
p har mac o ki netic(s)
P S
Patie nt Safet y
R A N K L
rece pt or acti vat or of n uclear fact or ka p pa B li ga n d
R B C
re d bl o o d cell

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 9
2 4 Oct o ber 2 0 2 3
R E CI S T
Res p o nse E val uati o n Criteria i n S oli d T u m ors
R h
r hes us
R N A
ri b o n ucleic aci d
R O
rece pt or occ u pa nc y
R P 2 D
rec o m me n de d P hase 2 d ose
S A E
seri o us a d verse e ve nt
S C L C
s mall cell l u n g ca ncer
SI R P α
si g nal re g ulat or y pr otei n al p ha
S m P C
s u m mar y of pr o d uct c haracteristics
S O P
sta n dar d o perati n g pr oce d ure
S R T
safet y re vie w tea m
S S Rs
s pecial sit uati o n re p orts
S U S A R
s us pecte d u ne x pecte d seri o us a d verse reacti o n
T C R
T cell rece pt or
U C
ur ot helial ca ncer
U L N
u p per li mit of n or mal
U S
U nite d States
U S PI
U nite d States prescri bi n g i nf or mati o n
w/ v
wei g ht-t o- v ol u me rati o
W E S
w h ole e x o me se q ue nci n g

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 2 0
2 4 Oct o ber 2 0 2 3
1.  
I N T R O D U C TI O N
1. 1.  
B ac k gr o u n d
1. 1. 1.  
B ac k gr o u n d o n Rel a pse d/ Refr act or y S oli d T u m ors I ncl u di n g Met ast atic 
N o n- S m all Cell L u n g C a ncer, Met ast atic Ur ot heli al C a ncer, a n d Met ast atic 
S m all Cell L u n g C a ncer
F or ma n y s oli d t u m ors, i m m u ne c hec k p oi nt i n hi bit ors, s pecificall y a nti – pr o gra m me d cell deat h 
pr otei n 1 ( P D- 1) a n d a nti – pr o gra m me d cell deat h li ga n d- 1 ( P D- L 1) a nti b o dies, ha ve dra maticall y 
i m pr o ve d t he treat me nt o utc o mes f or patie nts. Se veral T-cell c hec k p oi nt i n hi bit ors are 
U nite d States ( U S) F o o d a n d Dr u g A d mi nistrati o n ( F D A) a p pr o ve d f or m ulti ple s oli d t u m ors 
i ncl u di n g pe m br oliz u ma b, ni v ol u ma b, atez oliz u ma b, d ur val u ma b, a vel u ma b, a n d ce mi pli ma b. 
F or m ost t u m or t y pes, sta n dar d of care f or fr o ntli ne treat me nt c o nsists of c o m bi nati o n 
c he m ot hera p y, i m m u ne c hec k p oi nt i n hi bit ors, or t he c o m bi nati o n. H o we ver, o nce patie nts fail 
sta n dar d c he m ot hera p y a n d/ or i m m u ne c hec k p oi nt i n hi bit ors, treat me nt o pti o ns are ge nerall y 
m ore li mite d. Ofte n, si n gle-a ge nt c he m ot hera p y is sta n dar d of care i n t his setti n g. Efficac y is 
li mite d i n t his setti n g wit h o bser ve d o bjecti ve res p o nse rates ( O R Rs) ar o u n d 1 0 % f or m ost 
si n gle-a ge nt c he m ot hera pe utic re gi me ns. T h us, n o vel a ge nts t hat ca n safel y c o m bi ne a n d 
e n ha nce efficac y of t hese c he m ot hera pies are nee de d t o i m pr o ve treat me nt o utc o mes i n t his 
setti n g. T his st u d y will i nitiall y e val uate ma gr oli ma b c o m bi nati o n wit h c he m ot hera p y i n m ulti ple 
s oli d t u m ors i ncl u di n g metastatic n o n –s mall cell l u n g ca ncer ( m N S C L C), metastatic ur ot helial 
ca ncer ( m U C), a n d metastatic s mall cell l u n g ca ncer ( m S C L C).
1. 1. 1. 1.   
N S C L C Bac k gr o u n d
L u n g ca ncer is t he lea di n g ca use of ca ncer-relate d m ortalit y. A p pr o xi matel y 8 0 % t o 8 5 % of all 
l u n g ca ncers are N S C L C. Rece nt a d va nces wit h i m m u ne c hec k p oi nt i n hi bit or t hera p y ha ve 
dra maticall y i m pr o ve d t he pr o g n osis of l u n g ca ncer a n d t hese i m m u ne c hec k p oi nt i n hi bit or 
t hera pies, as m o n ot hera p y or i n c o m bi nati o n, are mai nl y use d i n t he fr o ntli ne metastatic setti n g. 
H o we ver, after fail ure of i m m u ne c hec k p oi nt i n hi bit or t hera p y a n d/ or fr o ntli ne c he m ot hera p y, 
t here are li mite d treat me nt o pti o ns f or t he maj orit y of patie nts. Acc or di n g t o Nati o nal 
C o m pre he nsi ve Ca ncer Net w or k ( N C C N) g ui deli nes, t he use of si n gle-a ge nt c he m ot hera p y 
(i ncl u di n g ta xa nes) is t he sta n dar d of care f or patie nts wit h rec urre nt or metastatic N S C L C after 
fail ure of plati n u m- base d t hera p y a n d/ or i m m u ne c hec k p oi nt t hera p y {Etti n ger 2 0 1 9 }. T he mai n 
o pti o ns f or si n gle-a ge nt c he m ot hera p y i n t his setti n g ge nerall y i ncl u de d oceta xel ( wit h or 
wit h o ut ra m ucir u ma b), erl oti ni b, a n d pe metre xe d. Hist orical me dia n pr o gressi o n-free s ur vi val 
( P F S) rates i n sec o n d-li ne N S C L C treate d wit h si n gle-a ge nt c he m ot hera p y is a p pr o xi matel y 
3 m o nt hs wit h a me dia n s ur vi val of a p pr o xi matel y 6 t o 8 m o nt hs { S he p her d 2 0 0 0 }. T h us, n o vel 
a ge nts t hat ca n safel y c o m bi ne wit h si n gle-a ge nt c he m ot hera p y a n d i m pr o ve cli nical efficac y are 
nee de d.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 2 1
2 4 Oct o ber 2 0 2 3
1. 1. 1. 2.  
S C L C Bac k gr o u n d
S mall cell l u n g ca ncer is a ne ur oe n d ocri ne t u m or t hat re prese nts a p pr o xi matel y 1 5 % of all l u n g 
ca ncers. S mall cell l u n g ca ncer pre d o mi na ntl y occ urs i n s m o kers a n d is disti n g uis he d fr o m ot her 
N S C L C t y pes b y its ra pi d pr oliferati o n rate, earl y de vel o p me nt of metastases, a n d i nitial 
prese ntati o n wit h disse mi nate d disease. W hile patie nts wit h S C L C te n d t o i nitiall y prese nt wit h 
metastatic disease, S C L C is hi g hl y res p o nsi ve t o c he m ot hera pe utic a ge nts ( wit h a n d wit h o ut 
ra diati o n), w hic h are t he mai nsta y of fr o ntli ne treat me nt. Fr o ntli ne c he m ot hera p y ge nerall y 
c o nsists of plati n u m- base d c o m bi nati o ns (ie, plati n u m + et o p osi de). Me dia n o verall s ur vi val ( O S) 
wit h plati n u m- base d c he m ot hera pies i n t he fr o ntli ne metastatic setti n g is a p pr o xi matel y 9 t o 
1 0 m o nt hs { R ossi 2 0 1 2 }. Rece ntl y, t he a d diti o n of i m m u ne c hec k p oi nt i n hi bit ors t o fr o ntli ne 
plati n u m- base d c he m ot hera p y c o m bi nati o ns ha ve de m o nstrate d i m pr o ve me nt i n cli nical o utc o mes 
lea di n g t o F D A a p pr o val of c hec k p oi nt i n hi bit ors (atez oliz u ma b a n d d ur val u ma b) i n t he fr o ntli ne 
metastatic disease p o p ulati o n. I n a ra n d o mize d P hase 3 st u d y, atez oliz u ma b i n c o m bi nati o n wit h 
car b o plati n a n d et o p osi de de m o nstrate d a statisticall y si g nifica nt i m pr o ve me nt i n P F S c o m pare d t o 
car b o plati n + et o p osi de ( 1 2. 3 vs 1 0. 3 m o nt hs, hazar d rati o [ H R] = 0. 7 0) wit h a si milar t o xicit y 
pr ofile acr oss b ot h gr o u ps { H or n 2 0 1 8 }. I n a n ot her P hase 3 st u d y, d ur val u ma b i n c o m bi nati o n 
wit h plati n u m-et o p osi de le d t o a n i m pr o ve me nt i n O S c o m pare d t o c he m ot hera p y c o ntr ol ( 1 2. 9 vs 
1 0. 5 m o nt hs, H R = 0. 7 5) { Paz ‑Ares 2 0 1 9 }. T h us, t he a d diti o n of i m m u ne c hec k p oi nt i n hi bit ors t o 
c he m ot hera p y has le d t o m o derate i m pr o ve me nts t o patie nt o utc o mes i n t he fr o ntli ne metastatic 
setti n g. F or patie nts w h o fail fr o ntli ne c he m ot hera p y wit h or wit h o ut a n i m m u ne c hec k p oi nt 
i n hi bit or, t here are li mite d treat me nt o pti o ns, wit h si n gle-a ge nt c he m ot hera p y as t he mai n sta n dar d 
of care. T he me dia n O S i n t his a d va nce d later li ne setti n g is a p pr o xi matel y 6 m o nt hs { S mit 1 9 9 8 , 
Ya ma m ot o 2 0 0 6 }. N o vel treat me nt o pti o ns or c o m bi nati o ns i n t he a d va nce d later li ne setti n g are 
nee de d t o i m pr o ve o utc o mes.
1. 1. 1. 3.   
U C Bac k gr o u n d
Bla d der ca ncer is t he m ost c o m m o n mali g na nc y i n v ol vi n g t he uri nar y s yste m. Ur ot helial 
carci n o ma is t he pre d o mi na nt hist ol o gic t y pe i n t he U S a n d E ur o pe, acc o u nti n g f or o ver 9 0 % of all 
bla d der ca ncers. S yste mic c he m ot hera p y is t he sta n dar d a p pr oac h f or t he i nitial treat me nt of 
patie nts wit h i n o pera ble l ocall y a d va nce d or metastatic ur ot helial ca ncer ( U C). Alt h o u g h i nitial 
res p o nse rates are hi g h, t he me dia n O S wit h c o m bi nati o n c he m ot hera p y ( pri maril y cis plati n- base d) 
is a p pr o xi matel y 1 5 m o nt hs {v o n der Maase 2 0 0 0 }. Rece ntl y, i m m u ne c hec k p oi nt i n hi bit or 
t hera pies ( n ota bl y pe m br oliz u ma b a n d atez oliz u ma b) ha ve m o ve d i nt o t he fr o ntli ne setti n g, 
partic ularl y f or t h ose w h o are i neli gi ble f or cis plati n t hera p y. T his usa ge is pri maril y base d o n 
P hase 2 st u dies de m o nstrati n g a 2 9 % O R R, me dia n d urati o n of res p o nse ( D O R) of 3 0 m o nt hs, a n d 
me dia n O S of 1 1. 3 m o nt hs f or pe m br oliz u ma b { V u k y 2 0 2 0 }. Si milar efficac y data ha ve bee n 
o bser ve d wit h atez oliz u ma b { Balar 2 0 1 7 }. I m m u ne c hec k p oi nt t hera p y i n c o m bi nati o n wit h 
c he m ot hera p y is bei n g e val uate d i n t he fr o ntli ne metastatic setti n g. I n a d diti o n t o fr o ntli ne patie nts 
w h o are i neli gi ble f or cis plati n- base d c he m ot hera p y, i m m u ne c hec k p oi nt t hera p y is pri maril y use d 
i n patie nts w h o fail fr o ntli ne c he m ot hera p y. M ulti ple i m m u ne c hec k p oi nt i n hi bit ors are a p pr o ve d 
i n t his setti n g base d o n eit her P hase 2 or ra n d o mize d P hase 3 data base d o n eit her e nc o ura gi n g 
d ura ble res p o nse rates or i m pr o ve me nt i n P F S c o m pare d t o c he m ot hera p y sta n dar d of care. Lastl y, 
a n o vel m o dalit y of a nti b o d y- dr u g c o nj u gates ( A D Cs) ha ve als o rece ntl y de m o nstrate d be nefit i n 
U C. E nf ort u ma b ve d oti n, a necti n- 4 A D C, was a p pr o ve d i n 2 0 1 9 f or t he treat me nt of l ocall y 

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 2 2
2 4 Oct o ber 2 0 2 3
a d va nce d or metastatic U C i n patie nts w h o pre vi o usl y recei ve d a n a nti- P D- 1/ L 1 i n hi bit or a n d a 
plati n u m-c o ntai ni n g c he m ot hera p y re gi me n. T his a p pr o val was base d o n a P hase 2 st u d y 
de m o nstrati n g a n O R R of 4 4 % wit h a me dia n P F S of 6 m o nt hs. I n s u m mar y, rece nt treat me nt 
a d va nces i ncl u di n g i m m u ne c hec k p oi nt i n hi bit ors a n d A D Cs ha ve i m pr o ve d t he treat me nt 
o utc o mes i n patie nts wit h m U C. H o we ver, patie nts i n t he a d va nce d later li ne setti n g, es peciall y 
after 2 li nes of t hera p y, ha ve li mite d treat me nt o pti o ns a n d re q uire m ore effecti ve t hera pies. 
C urre ntl y, atez oliz u ma b is bei n g i n vesti gate d i n c o m bi nati o n wit h ma gr oli ma b i n m U C 
( N C T I D # 0 3 8 6 9 1 9 0).
1. 2.   
M a gr oli m a b
1. 2. 1.   
Ge ner al I nf or m ati o n
Cl uster of differe ntiati o n 4 7 ( C D 4 7) is a ke y m olec ule me diati n g ca ncer cell e vasi o n of i n nate 
i m m u ne s ur veilla nce. C D 4 7 e x pressi o n is a well-c haracterize d mec ha nis m b y w hic h ca ncer cells, 
i ncl u di n g ca ncer ste m cells, o verc o me p ha g oc yt osis d ue t o i ntri nsic e x pressi o n of pr o p ha g oc ytic 
“eat me” si g nals { Jais wal 2 0 0 9, Majeti 2 0 0 9 }. T he pr o gressi o n fr o m n or mal cell t o ca ncer cell 
i n v ol ves c ha n ges i n ge nes a n d ge ne e x pressi o n t hat tri g ger pr o gra m me d cell deat h a n d 
pr o gra m me d cell re m o val { C ha o 2 0 1 2 }. Ma n y of t he ste ps i n ca ncer pr o gressi o n s u b vert t he 
m ulti ple mec ha nis ms of pr o gra m me d cell deat h, a n d t he e x pressi o n of t he d o mi na nt 
a nti p ha g oc ytic si g nal, C D 4 7, ma y re prese nt a n i m p orta nt c hec k p oi nt { C ha o 2 0 1 2 }. I ncrease d 
C D 4 7 e x pressi o n was i de ntifi e d first o n le u ke mic ste m cells i n h u ma n ac ute m yel oi d le u ke mia 
( A M L) {Majeti 2 0 0 9 }, a n d si nce t he n it has bee n f o u n d t hat C D 4 7 e x pressi o n is i ncrease d o n t he 
s urface of ca ncer cells i n a di verse set of h u ma n t u m or t y pes.
I n m o use xe n o graft m o dels, C D 4 7- bl oc ki n g m o n ocl o nal a nti b o dies ( m A bs) i n hi bit h u ma n 
xe n o graft t u m or gr o wt h a n d metastasis b y e na bli n g t he p ha g oc yt osis a n d eli mi nati o n of ca ncer 
cells fr o m vari o us he mat ol o gic mali g na ncies a n d s oli d t u m ors { C ha o 2 0 1 1a , C ha o 2 0 1 0a , C ha o 
2 0 1 1 b , E dris 2 0 1 2 , Ki m 2 0 1 2 , Majeti 2 0 0 9 , Willi n g ha m 2 0 1 2 }. Bi n di n g of C D 4 7 e x presse d b y 
ca ncer cells t o its li ga n d, si g nal re g ulat or y pr otei n al p ha ( SI R Pα ), e x presse d o n p ha g oc ytes lea ds 
t o i n hi biti o n of t u m or cell p ha g oc yt osis. T h us, bl oc ka de of t he C D 4 7 SI R Pα -si g nali n g pat h wa y 
b y a n a nti- C D 4 7 a nti b o d y lea ds t o p ha g oc yt osis a n d eli mi nati o n of t u m or cells. Selecti ve 
tar geti n g of t u m or cells b y a n a nti- C D 4 7 a nti b o d y is d ue t o t he prese nce of pr o p ha g oc ytic si g nals 
e x presse d mai nl y o n t u m or cells a n d n ot o n n or mal cell c o u nter parts { C ha o 2 0 1 0 b }. I n a d diti o n, 
t he a nti- C D 4 7 a nti b o d y ca n i n d uce a n a ntica ncer T-cell res p o nse t hr o u g h cr oss- prese ntati o n of 
t u m or a nti ge ns b y macr o p ha ge a n d a nti ge n- prese nti n g cells after t u m or cell p ha g oc yt osis {Li u 
2 0 1 5 b , Tse n g 2 0 1 3 }.
Ma gr oli ma b is a h u ma nize d a nti- C D 4 7 m A b t hat bl oc ks t he i nteracti o n of C D 4 7 wit h its rece pt or 
a n d e na bles p ha g oc yt osis of h u ma n ca ncer cells { Li u 2 0 1 5a }. T he acti vit y of ma gr oli ma b is 
pri maril y de pe n de nt o n bl oc ki n g C D 4 7 bi n di n g t o SI R P α a n d n ot o n t he recr uit me nt of fra g me nt 
cr ystalliza ble ( Fc)- de pe n de nt effect or f u ncti o ns, alt h o u g h t he prese nce of t he i m m u n o gl o b uli n 
G 4 (I g G 4) Fc d o mai n is re q uire d f or its f ull acti vit y. F or t his reas o n, ma gr oli ma b was 
e n gi neere d wit h a h u ma n I g G 4 is ot y pe t hat is relati vel y i nefficie nt at recr uiti n g Fc- de pe n de nt 
effect or f u ncti o ns t hat mi g ht e n ha nce t o xic effects o n n or mal C D 4 7-e x pressi n g cells { Li u 
2 0 1 5a }. N o ncli nical st u dies usi n g xe n o graft ca ncer m o dels pr o vi de c o m pelli n g e vi de nce t hat 
ma gr oli ma b tri g gers p ha g oc yt osis a n d eli mi nati o n of ca ncer cells fr o m h u ma n s oli d t u m ors a n d 

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 2 3
2 4 Oct o ber 2 0 2 3
he mat ol o gic mali g na ncies. Base d o n t his mec ha nis m of acti o n ( M O A) a n d its p ote nt n o ncli nical 
acti vit y, ma gr oli ma b is bei n g de vel o pe d as a n o vel t hera pe utic ca n di date f or s oli d t u m ors a n d 
he mat ol o gic mali g na ncies.
T he ma gr oli ma b cli nical de vel o p me nt pr o gra m re prese nts a n o vel strate g y f or t he treat me nt of 
ca ncer a n d is t he first t hera pe utic a ge nt t o tar get t he C D 4 7- SI R P α a xis. E xte nsi ve n o ncli nical 
st u dies ha ve de m o nstrate d acti vit y a gai nst b ot h h u ma n s oli d t u m ors ( breast, o varia n, pa ncreas, 
c ol o n, lei o m y osarc o ma, bla d der, pr ostate, a n d ot hers) a n d he mat ol o gic mali g na ncies 
( A M L, ac ute l y m p h o blastic le u ke mia, n o n- H o d g ki n l y m p h o ma [ N H L], m yel o ma, 
m yel o d ys plastic s y n dr o me [ M D S], a n d ot hers).
As per t he 2 0 2 0 i n vesti gat or’s br oc h ure (I B), ma gr oli ma b is bei n g i n vesti gate d as a n a ntica ncer 
t hera pe utic i n 6 o n g oi n g cli nical st u dies i n t he U S a n d U nite d Ki n g d o m, as m o n ot hera p y or i n 
c o m bi nati o n wit h ot her t hera pe utics, f or t he treat me nt of N H L, c ol orectal ca ncer ( C R C), A M L, 
M D S, a n d o varia n ca ncer. A t otal of 5 6 8 patie nts ha ve bee n treate d as per t he data c ut- off dates 
i n t he 2 0 2 0 I B.
W hile ma gr oli ma b has si n gle-a ge nt n o ncli nical a n d cli nical acti vit y, efficac y is best e n ha nce d i n 
c o m bi nati o n wit h ot her a ntica ncer a ge nts. N o ncli nical a n d cli nical st u dies ha ve s h o w n t hat 
ma gr oli ma b c o m bi nati o ns wit h c yt ot o xic a ge nts ca n e n ha nce pr o p ha g oc ytic si g nals o n t u m or 
cells t hr o u g h c yt ot o xicit y, w hic h ca n lea d t o s y ner gistic p ha g oc yt osis of t u m or cells a n d 
e n ha nce d acti vit y. As s uc h, ma gr oli ma b is bei n g e val uate d cli nicall y i n se veral c o m bi nati o ns 
wit h c yt ot o xic a ge nts i ncl u di n g c he m ot hera p y.
F or f urt her i nf or mati o n o n ma gr oli ma b, refer t o t he c urre nt I B.
1. 2. 2.   
N o ncli nic al P h ar m ac ol o g y a n d T o xic ol o g y
1. 2. 2. 1.  
P har mac ol o g y
I n vitr o st u dies of ma gr oli ma b acti vit y i ncl u de d pr otei n a n d cell- base d assa ys usi n g ca ncer cell 
li nes. Ma gr oli ma b s h o we d hi g h bi n di n g affi nit y t o m o n o meric a n d bi vale nt h u ma n C D 4 7 a nti ge n 
wit h a K
D  of 8 × 1 0- 9 a n d 8 × 1 0- 1 2 M, res pecti vel y. Ma gr oli ma b b o u n d t o c y n o m ol g us m o n ke y 
a n d h u ma n C D 4 7 wit h hi g h affi nit y of K D  = 1 0 a n d 8. 0 p M, res pecti vel y, b ut di d n ot bi n d t o 
m o use C D 4 7. N o c o m ple me nt- de pe n de nt c yt ot o xicit y acti vit y of ma gr oli ma b was o bser ve d i n 
A M L cells, a n d n o a nti b o d y- de pe n de nt cell- me diate d c yt ot o xicit y acti vit y of ma gr oli ma b was 
o bser ve d i n Raji a n d H L 6 0 cells. Ma gr oli ma b-i n d uce d macr o p ha ge- me diate d p ha g oc yt osis i n rat 
m yel o ma a n d H L 6 0 cells a n d di d n ot i n d uce a p o pt osis i n A M L cells. E x pressi o n of C D 4 7 was 
o bser ve d o n h u ma n peri p heral bl o o d cells, a n d ma gr oli ma b di d n ot tri g ger p ha g oc yt osis b y 
h u ma n macr o p ha ges of n or mal re d bl o o d cells ( R B Cs) or n or mal h u ma n b o ne marr o w cells i n 
vitr o b ut was a p ote nt i n d ucer of p ha g oc yt osis of C D 4 7-e x pressi n g A M L cells i n vitr o. 
Treat me nt of A M L cells wit h h y dr o x y urea ( H U) ha d n o effect o n ma gr oli ma b-i n d uce d 
p ha g oc yt osis, n or di d H U treat me nt tri g ger ma gr oli ma b-i n d uce d p ha g oc yt osis of n or mal b o ne 
marr o w cells. I n c o ntrast, t he c o m bi nati o n of ma gr oli ma b a n d a vel u ma b effecti vel y e n ha nce d 
p ha g oc yt osis of o varia n ca ncer cells b y h u ma n macr o p ha ges c o m pare d t o ma gr oli ma b or 
a vel u ma b al o ne. M ore o ver, t he c o m bi nati o n of ma gr oli ma b wit h c yt ot o xic a ge nt azaciti di ne at a 
cli nicall y rele va nt c o nce ntrati o n e n ha nce d p ha g oc yt osis of H L 6 0 cells i n vitr o w he n c o m pare d t o 
ma gr oli ma b or azaciti di ne al o ne.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 2 4
2 4 Oct o ber 2 0 2 3
N o ncli nical i n vi v o p har mac ol o g y st u dies usi n g xe n o graft ca ncer m o dels pr o vi de c o m pelli n g 
e vi de nce t hat ma gr oli ma b tri g gers p ha g oc yt osis a n d eli mi nati o n of ca ncer cells fr o m m ulti ple 
h u ma n s oli d t u m ors a n d he mat ol o gic mali g na ncies. O verall, ma gr oli ma b i n c o m bi nati o n wit h 
azaciti di ne, trast uz u ma b, rit u xi ma b, cet u xi ma b, a n d pa nit u m u ma b de m o nstrate d a d diti ve effect 
o n eli mi nati n g ca ncer cells, res ulti n g i n a l o n g-ter m re missi o n a n d i ncrease d s ur vi val of a ni mals.
Rece pt or occ u pa nc y ( R O) assa ys s h o we d t hat o pti mal a ntit u m or acti vit y ( p ha g oc yt osis) i n 
H L 6 0 cells a n d pri mar y h u ma n A M L cells c o ul d be ac hie ve d wit h o ut f ull C D 4 7 R O.
T he safet y p har mac ol o g y e val uati o ns as part of a G o o d La b orat or y Practice 8- wee k t o xic ol o g y 
st u d y de m o nstrate d n o ma gr oli ma b-relate d effects o n ce ntral ner v o us s yste m ( C N S), 
car di o vasc ular, or res pirat or y f u ncti o n i n c y n o m ol g us m o n ke y.
1. 2. 2. 2.  
T o xic ol o g y
I n i n vitr o st u dies, ma gr oli ma b was n ot he m ol ytic a n d t here was n o e vi de nce of a d verse 
ele vati o ns of pr oi nfla m mat or y c yt o ki nes.
I n t he pi v otal 8- wee k re peat- d ose t o xic ol o g y st u d y, ma gr oli ma b was a d mi nistere d t o 
c y n o m ol g us m o n ke ys via a 1- h o ur i ntra ve n o us (I V) i nf usi o n as a pri mi n g d ose of 5 m g/ k g i n 
Wee k 1 ( Da y 1), f oll o we d b y t wice- wee kl y mai nte na nce d oses f or 7 c o nsec uti ve wee ks at d oses 
ra n gi n g fr o m 5 t o 1 0 0 m g/ k g.
Treat me nt-relate d fi n di n gs were li mite d t o c ha n ges i n he mat ol o g y a n d cli nical c he mistr y 
para meters a n d er yt hr oi d cell m or p h ol o g y.
He mat ol o g y c ha n ges i ncl u de d decreases i n R B C mass ass ociate d wit h decreases i n mea n 
c or p usc ular v ol u me a n d ha pt o gl o bi n; i ncreases i n mea n c or p usc ular he m o gl o bi n c o nce ntrati o n, 
retic ul oc ytes, a n d R B C distri b uti o n wi dt h; R B C m or p h ol o g y c ha n ges i ncl u di n g s p her oc ytes 
( micr oc ytes), ecce ntr oc ytes, at y pical er yt hr oc yte fra g me nts c o nsiste nt wit h er yt hr oc yte i nj ur y, 
er yt hr oc yte cl u m pi n g, a n d lar ge platelets; a n d c ha n ges ass ociate d wit h i ncrease d er yt hr o p oiesis 
c o nsisti n g of a nis oc yt osis, p ol yc hr o mat o p hilic macr oc ytes, a n d i ncrease d t otal bilir u bi n.
C ha n ges i n bl o o d cell m or p h ol o g y were c o nsiste nt wit h pre vi o us st u dies a n d c o nsi dere d t o be 
ass ociate d wit h accelerate d R B C destr ucti o n/cleara nce a n d i ncrease d er yt hr o p oiesis.
A d diti o nal cli nical c he mistr y c ha n ges were o bser ve d at t he hi g hest d ose o nl y ( 1 0 0 m g/ k g), 
w hic h i ncl u de d a sli g ht decrease i n al b u mi n, a sli g ht i ncrease i n gl o b uli n, a n d a c orres p o n di n g 
decrease i n al b u mi n: gl o b uli n rati o. T here was partial t o c o m plete rec o ver y f or all 
treat me nt-relate d c ha n ges e xce pt f or i ncrease d s plee n wei g hts i n males a n d fe males at 5 0 a n d 
1 0 0 m g/ k g at rec o ver y necr o ps y, w hic h ha d n o macr osc o pic or micr osc o pic c orrelate. Base d o n 
t hese res ults, t he hi g hest n o n –se verel y t o xic d ose f or t his st u d y was c o nsi dere d t o be 1 0 0 m g/ k g, 
t he hi g hest d ose e val uate d.
Re pr o d ucti ve a n d de vel o p me ntal t o xic ol o g y st u dies ha ve n ot bee n c o n d ucte d i n h o use, b ut all 
t he a vaila ble data (literat ure, data fr o m k n oc k o ut mice, a n d li mite d cli nical data) s u g gest n o r ole 
f or C D 4 7 o n e m br y o-fetal de vel o p me nt.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 2 5
2 4 Oct o ber 2 0 2 3
1. 2. 3.   
Cli nic al B ac k gr o u n d f or M a gr oli m a b
1. 2. 3. 1.  
S u m mar y of Cli nical P har mac ol o g y
Cli nical p har mac o ki netic ( P K) data ha ve bee n c ollecte d i n all o n g oi n g st u dies of ma gr oli ma b 
c o n d ucte d t o date. P har mac o ki netic data ha ve bee n a nal yze d i n a P hase 1 st u d y ( S CI -C D 4 7- 0 0 1) 
i n patie nts wit h s oli d t u m or. I n t his st u d y, patie nts were treate d wit h wee kl y ma gr oli ma b d oses 
ra n ge d fr o m 0. 1 t o 4 5 m g/ k g, wit h i ncreasi n g ser u m c o nce ntrati o ns ass ociate d wit h i ncreasi n g 
d ose. N o nli near P K c o nsiste nt wit h tar get- me diate d cleara nce was o bser ve d o ver t his d ose ra n ge. 
H o we ver, at mai nte na nce d oses of 1 0 m g/ k g a n d a b o ve, tar get- me diate d cleara nce was sat urate d 
wit hi n t he d osi n g re gi me n, a n d tr o u g h le vels ass ociate d wit h ma gr oli ma b efficac y i n n o ncli nical 
st u dies were ac hie ve d. Ni ne of 8 8 ( 1 0 %) e val ua ble patie nts teste d p ositi ve f or a nti dr u g a nti b o d y 
( A D A) a gai nst ma gr oli ma b at a n y ti me p oi nt i ncl u di n g baseli ne; A D A p ositi vit y ha d n o i m pact 
o n P K or cli nical safet y i n t hese patie nts.
I n a P hase 1 A M L st u d y ( S CI- C D 4 7- 0 0 2), si milar t o t he s oli d t u m or P hase 1 st u d y, n o nli near P K 
c o nsiste nt wit h tar get- me diate d cleara nce was o bser ve d. T hree of 2 0 ( 1 5 %) e val ua ble patie nts 
teste d p ositi ve f or A D A a gai nst ma gr oli ma b at a n y ti me p oi nt i ncl u di n g baseli ne; A D A 
p ositi vit y ha d n o i m pact o n P K. A nti dr u g a nti b o d y p ositi vit y i n eit her st u d y was n ot ass ociate d 
wit h i ncrease d a d verse e ve nts ( A Es).
Preli mi nar y P K data of ma gr oli ma b fr o m ot her o n g oi n g st u dies ( 5 F 9 0 0 3, 5 F 9 0 0 4, a n d 5 F 9 0 0 5) 
of ma gr oli ma b i n dicate si milar P K pr o perties acr oss all t u m or p o p ulati o ns a n d i n t he prese nce of 
c oa d mi nistere d dr u gs. Acr oss all st u dies, 4 6 of 4 3 0 ( 1 1 %) patie nts teste d p ositi ve f or A D A 
a gai nst ma gr oli ma b at a n y ti me p oi nt i ncl u di n g baseli ne. A nti dr u g a nti b o d y p ositi vit y was n ot 
ass ociate d wit h c ha n ges i n P K or A E pr ofile.
A preli mi nar y p o p ulati o n P K a nal ysis of c o m bi ne d ma gr oli ma b P K data i n dicate d t hat res ults f or 
ma gr oli ma b p o p ulati o n P K were t y pical of ot her n o nli near a nti b o dies. N o cli nicall y si g nifica nt 
c o variates of P K varia bilit y were i de ntifie d.
1. 2. 3. 2.  
S u m mar y of Cli nical Safet y
Ma gr oli ma b is a d mi nistere d as a n I V i nf usi o n a n d it is c urre ntl y bei n g st u die d i n 6 cli nical 
st u dies. T w o c o m plete d si n gle-a ge nt P hase 1 st u dies i ncl u de St u d y S CI-C D 4 7 -0 0 1 i n patie nts 
wit h a d va nce d s oli d t u m ors a n d l y m p h o mas, a n d St u d y S CI -C D 4 7 -0 0 2 i n patie nts wit h a d va nce d 
later li ne A M L, al o n g wit h 2 P hase 1 b part nere d st u dies i n A M L as well as U C. F o ur 
c o m bi nati o n st u dies i ncl u de t he f oll o wi n g: St u d y 5 F 9 0 0 3, a P hase 1 b/ 2 st u d y of ma gr oli ma b 
wit h rit u xi ma b i n patie nts wit h a d va nce d later li ne N H L; St u d y 5 F 9 0 0 4, a P hase 1 b/ 2 st u d y of 
ma gr oli ma b wit h cet u xi ma b i n patie nts wit h s oli d t u m or a n d C R C; St u d y 5 F 9 0 0 5, a P hase 1 b 
st u d y of ma gr oli ma b wit h azaciti di ne i n patie nts wit h A M L a n d M D S; a n d St u d y 5 F 9 0 0 6, a 
P hase 1 b st u d y of ma gr oli ma b wit h a vel u ma b i n patie nts wit h s oli d t u m or a n d o varia n ca ncer. As 
of J ul y 2 0 2 0, o ver 5 0 0 patie nts ha ve bee n treate d wit h ma gr oli ma b. O verall, t he safet y pr ofile 
has bee n acce pta ble wit h ma gr oli ma b as m o n ot hera p y or i n c o m bi nati o n, wit h n o ma xi m u m 
t olerate d d ose ( M T D) reac he d i n a n y st u d y wit h d osi n g u p t o 4 5 m g/ k g. T w o a ntici pate d a d verse 
reacti o ns i ncl u de d o n-tar get a ne mia a n d i nf usi o n-relate d reacti o ns (I R Rs), w hic h are e x pecte d 
wit h m A bs. I m p orta ntl y, o n-tar get a ne mia d ue t o C D 4 7 bl oc ka de- me diate d R B C cleara nce was 

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 2 6
2 4 Oct o ber 2 0 2 3
miti gate d wit h a pri mi n g/ mai nte na nce d ose strate g y. T he a vera ge he m o gl o bi n decli ne wit h t he 
first ( pri mi n g) d ose was bet wee n a p pr o xi matel y 0. 4 t o 1. 5 g/ d L acr oss i n dicati o ns, wit h ma n y 
patie nts i m pr o vi n g t heir he m o gl o bi n o n t hera p y bac k t o baseli ne wit h a decrease i n R B C 
tra nsf usi o n re q uire me nts f or t h ose patie nts w h o were tra nsf usi o n- de pe n de nt at baseli ne.
Ma gr oli ma b has bee n e val uate d as a m o n ot hera p y or i n c o m bi nati o n i n m ulti ple s oli d t u m or 
t y pes. I n t he P hase 1 St u d y S CI- C D 4 7- 0 0 1 of ma gr oli ma b m o n ot hera p y, 8 8 patie nts wit h 
a d va nce d s oli d t u m ors were treate d wit h ma gr oli ma b d oses u p t o 4 5 m g/ k g. N o M T D was 
reac he d. As per t he 2 0 2 0 I B, acr oss 5 4 8 patie nts treate d wit h ma gr oli ma b, w hic h i ncl u des b ot h 
s oli d t u m ors a n d he mat ol o gic mali g na ncies, fati g ue, a ne mia, a n d hea dac he were t he 3 m ost 
fre q ue ntl y re p orte d A Es ( 4 3. 0 %, 4 0. 8 %, a n d 3 6. 4 % of patie nts, res pecti vel y). Patie nts 
e x perie nce d m ostl y Gra de 1 a n d 2 fati g ue ( 2. 8 % of patie nts re p orte d se vere fati g ue).
A ne mia is t he m ost c o m m o n treat me nt-relate d A E, re p orte d i n 3 5. 4 % of patie nts. A p pr o xi matel y 
1 3 % of all patie nts e x perie nce d a ne mia Gra de 1 or 2, a n d 2 2 % se vere a ne mia. N ota bl y ma n y of 
t h ose patie nts wit h se vere a ne mia occ urre d i n patie nts wit h A M L a n d M D S, w h o ha ve se vere 
a ne mia at baseli ne. A ne mia was t y picall y ma nifeste d as a decli ne i n he m o gl o bi n o bser ve d wit hi n 
t he first 2 wee ks of treat me nt. T he i nitial decrease i n he m o gl o bi n after t he first d ose is o n 
a vera ge 0. 5 t o 2 g/ d L. I n patie nts wit h s oli d t u m ors, t he fall i n he m o gl o bi n was f oll o we d b y a 
c o m pe nsat or y retic ul oc yt osis, wit h ma n y patie nts e x perie nci n g a gra d ual ret ur n t o baseli ne 
des pite c o nti n ue d d osi n g. T he c ha n ges i n he m o gl o bi n a n d retic ul oc ytes descri be d wit h 
ma gr oli ma b treat me nt are fairl y c o nsiste nt acr oss t u m or t y pes a n d are s h o w n i n Fi g ure 1 . 
H y per bilir u bi ne mia ( pre d o mi natel y u nc o nj u gate d) is i n dicati ve of e xtra vasc ular he m ol ysis 
c o nsiste nt wit h p ha g oc ytic re m o val of R B Cs arisi n g fr o m t he bl oc ka de of C D 4 7 si g nali n g. 
A d mi nistrati o n of a l o w pri mi n g d ose of ma gr oli ma b miti gate d o n-tar get a ne mia, a n effect t hat is 
m ostl y o bser ve d after t he first d ose.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 2 7
2 4 Oct o ber 2 0 2 3
Fi g ure 1.
Effect of M a gr oli m a b o n A ne mi a a n d Miti g ati o n wit h a 
Pri mi n g/ M ai nte n a nce D osi n g Re gi me n
T he re d bl o o d cell pr ofile of a s oli d t u m or patie nt treate d wit h ma gr oli ma b m o n ot hera p y is s h o w n { Si kic 2 0 1 9 }.
I nf usi o n-relate d reacti o ns are als o a c o m m o nl y o bser ve d A E wit h ma gr oli ma b. I n t otal, 2 9 % of 
patie nts re p orte d at least 1 I R R. M ost c o m m o n si g ns/s y m pt o ms of I R Rs relate d t o ma gr oli ma b 
i ncl u de d c hills, p yre xia, bac k pai n, hea dac he, na usea, v o miti n g, d ys p nea, a ne mia, a n d bl o o d 
bilir u bi n i ncrease. T hese I R Rs were ge nerall y o bser ve d d uri n g t he i nitial 2 d oses of ma gr oli ma b. 
C urre nt rec o m me n dati o ns f or pre me dicati o n a n d I R R ma na ge me nt are descri be d i n Secti o ns 5. 6  
a n d 7. 8. 1. 2 . Lastl y, he ma g gl uti nati o n ( R B C a g gl uti nati o n) as o bser ve d o n t he peri p heral s mear is 
a c o m m o n treat me nt effect a n d was re p orte d as a treat me nt-relate d A E i n 1 1. 8 % of all patie nts.
Tra nsie nt he ma g gl uti nati o n is o bser ve d after t he i nitial pri mi n g or first mai nte na nce d ose of 
dr u g, h o we ver, it is less c o m m o n t hereafter, a n d it has n ot bee n c o nsiste ntl y c orrelate d wit h a n y 
cli nical se q uelae.
I n s u m mar y, as of J ul y 2 0 2 0, 5 6 8 patie nts ( 3 4 6 s oli d t u m or/l y m p h o ma patie nts a n d 
2 2 2 A M L/ M D S patie nts) ha ve bee n treate d wit h ma gr oli ma b as m o n ot hera p y or i n c o m bi nati o n. 
Base d o n t his a g gre gate safet y data, ma gr oli ma b has a n acce pta ble safet y pr ofile b ot h as 
m o n ot hera p y a n d i n c o m bi nati o n wit h ot her a ge nts (rit u xi ma b, ge mcita bi ne, o xali plati n, 
cet u xi ma b, a vel u ma b, or azaciti di ne) acr oss m ulti ple a d va nce d s oli d t u m or a n d he mat ol o gic 
mali g na ncies. Refer t o t he ma gr oli ma b I B f or f urt her details.
1 6 
1 4 
::::i" 
"' C 1 2 -
0) 
1 0 
C 
Gr a d e  2  a n e mi a 
.. 0 
8 
0 
0) 
0 
6 
E 
Q.) 
4 
::: c 
D o s e  ( m g/k g) 
3 0 
3 0   
3 0   
3 0   
3 0 
3 0 
W e e k  
1 
2 
3 
4 
5 
6 
7 
5 F 9 
f pri mi n g 
1  m g /k g + 5 F 9 m ai nt e n a n c e 3 0 m g /k g  w e e kl y 
H e m o gl o bi n l o w er li mit of n or m al > 1 1 . 7-1 3 . 5  g/d L 
R eti c ul o c yt e s  u p p er li mit of n or m al  <  2. 2 8 % 
1 0 
8 
:: 0 
ct > 
d". 
6 
C ") 
C 
0 
C ") 
4 - s. 
ct > 
(/) -
2 
:::: R 
0 
3 0 
8 

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 2 8
2 4 Oct o ber 2 0 2 3
1. 2. 3. 3.  
S u m mar y of Cli nical Efficac y
Cli nical efficac y wit h ma gr oli ma b has bee n o bser ve d i n m ulti ple he mat ol o gic a n d s oli d t u m or 
mali g na ncies. I n t he P hase 1 St u d y S CI- C D 4 7- 0 0 1 of ma gr oli ma b m o n ot hera p y i n a d va nce d 
s oli d t u m ors, 2 patie nts wit h clear cell o varia n a n d fall o pia n t u be carci n o mas ac hie ve d a partial 
res p o nse per Res p o nse E val uati o n Criteria i n S oli d T u m ors ( R E CI S T, Versi o n 1. 1) wit h ti me t o 
pr o gressi o n of 5. 2 a n d 9. 2 m o nt hs, res pecti vel y { Si kic 2 0 1 9 }. I n a P hase 1 b/ 2 st u d y of 
ma gr oli ma b i n c o m bi nati o n wit h cet u xi ma b i n a d va nce d later li ne C R C patie nts ( St u d y 5 F 9 0 0 4), 
2 o bjecti ve res p o nses o ut of 3 2 patie nts ( 6 %) were o bser ve d i n a d va nce d later li ne metastatic 
K R A S wil dt y pe C R C patie nts w h o were refract or y t o cet u xi ma b wit h a disease c o ntr ol rate of 
5 0 % { Fis her 2 0 2 0 }. T he O S i n K R A S wil dt y pe a n d K R A S m uta nt C R C patie nts treate d wit h 
ma gr oli ma b a n d cet u xi ma b was 9. 5 a n d 7. 6 m o nt hs, res pecti vel y. T hese data ma y c o m pare 
fa v ora bl y t o hist orical data i n K R A S wil dt y pe a n d m uta nt patie nts treate d wit h sta n dar d of care 
wit h a me dia n O S of 8. 0 a n d 6. 5 m o nt hs, res pecti vel y { Va n C utse m 2 0 1 8 }.
I n he mat ol o gic mali g na ncies, efficac y has bee n o bser ve d i n N H L, M D S, a n d A M L. I n st u d y 
5 F 9 0 0 3, patie nts wit h a d va nce d later li ne N H L were treate d wit h ma gr oli ma b i n c o m bi nati o n 
wit h rit u xi ma b. I n 9 7 N H L patie nts e val ua ble f or efficac y t hat i ncl u de d diff use lar ge B-cell 
l y m p h o ma ( D L B C L) a n d i n d ole nt l y m p h o ma, t he O R R was 4 5 % wit h a c o m plete res p o nse ( C R) 
rate of 1 9 %. T he O R R i n D L B C L was 3 6 % i n 5 9 patie nts a n d 6 1 % f or 3 8 i n d ole nt l y m p h o ma 
patie nts treate d. I n St u d y 5 F 9 0 0 5, patie nts wit h u ntreate d A M L i neli gi ble f or i n d ucti o n 
c he m ot hera p y a n d u ntreate d hi g her-ris k M D S patie nts were treate d wit h ma gr oli ma b i n 
c o m bi nati o n wit h azaciti di ne. I n 2 5 A M L patie nts, t he O R R was 6 4 % a n d C R rate was 4 0 %. I n 
3 3 M D S patie nts, t he O R R was 9 1 % a n d C R rate was 4 2 %. N o me dia n D O R was reac he d f or 
eit her c o h ort wit h me dia n f oll o w- u p peri o d of 9. 4 m o nt hs f or A M L a n d 5. 8 m o nt hs f or M D S.
I n s u m mar y, ma gr oli ma b has de m o nstrate d c o m bi nati o n efficac y acr oss b ot h s oli d t u m ors a n d 
he mat ol o gic mali g na ncies. Refer t o t he ma gr oli ma b I B f or f urt her details.
1. 3.  
I nf or m ati o n A b o ut D ocet a xel
1. 3. 1.   
Descri pti o n of D ocet a xel
D oceta xel ( Ta x otere) is a n a ntica ncer c he m ot hera p y dr u g classifie d as a n a nti- micr ot u b ule 
i n hi bit or a n d ta xa ne. D oceta xel is i n dicate d f or m ulti ple s oli d t u m ors as a si n gle a ge nt 
{ Ta x otere ® 1 9 9 5 , Ta x otere ® 1 9 9 6 }.
1. 3. 2. 
Cli nic al D at a f or D ocet a xel
D oceta xel is a p pr o ve d f or use as m o n ot hera p y i n m ulti ple s oli d t u m ors i ncl u di n g N S C L C, hea d 
a n d nec k s q ua m o us cell carci n o ma, breast ca ncer, h or m o ne refract or y pr ostate ca ncer, a n d 
gastric a de n ocarci n o ma. D oceta xel is als o wi del y use d as sta n dar d of care i n m ulti ple s oli d 
t u m ors, i ncl u di n g m U C a n d m S C L C, w h o fail fr o ntli ne c he m ot hera p y a n d/ or i m m u ne 
c hec k p oi nt t hera p y { Ta x otere ® 1 9 9 5 , Ta x otere ® 1 9 9 6 }.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 2 9
2 4 Oct o ber 2 0 2 3
T he m ost c o m m o n A Es acr oss all d oceta xel i n dicati o ns are i nfecti o ns, ne utr o pe nia, a ne mia, 
fe brile ne utr o pe nia, h y perse nsiti vit y, t hr o m b oc yt o pe nia, ne ur o pat h y, d ys ge usia, d ys p nea, 
c o nsti pati o n, a n ore xia, nail dis or ders, fl ui d rete nti o n, ast he nia, pai n, na usea, diarr hea, v o miti n g, 
m uc ositis, al o pecia, s ki n reacti o ns, a n d m yal gia { Ta x otere ® 1 9 9 5 , Ta x otere ® 1 9 9 6 }. D oceta xel 
is c o ntrai n dicate d i n patie nts wit h ne utr o p hil c o u nts less t ha n 1 5 0 0 cells/ m m3 a n d i n patie nts 
wit h h y perse nsiti vit y t o d oceta xel or p ol ys or bate 8 0. D oceta xel carries a blac k b o x war ni n g f or 
t o xic deat hs, he pat ot o xicit y, ne utr o pe nia, h y perse nsiti vit y reacti o ns, a n d fl ui d rete nti o n. I n 
a d diti o n, c uta ne o us reacti o ns, se vere s ki n t o xicit y, ne ur ol o gic reacti o ns (i ncl u di n g parest hesia, 
d ysest hesia, a n d pai n), ast he nia, a n d p ote ntial fetal har m ha ve bee n o bser ve d wit h d oceta xel.
D oceta xel is sta n dar d of care as m o n ot hera p y f or a d va nce d later li ne patie nts i n m ulti ple s oli d 
t u m or t y pes i ncl u di n g m N S C L C, m U C, a n d m S C L C, i n dicati o ns st u die d i n t his pr ot oc ol. I n 
ge neral t he efficac y o bser ve d wit h d oceta xel m o n ot hera p y i n t hese t u m or t y pes i n patie nts w h o 
fail sta n dar d c he m ot hera p y, i m m u ne c hec k p oi nt i n hi bit or, or t he c o m bi nati o n res ults i n a n O R R 
of a p pr o xi matel y 1 0 % (ra n gi n g fr o m 9 % t o 1 3 % i n S C L C, U C, a n d N S C L C) { Bell m u nt 2 0 1 7 , 
Ritt me yer 2 0 1 7 , S mit 1 9 9 8 }. Me dia n P F S ra n ges fr o m a p pr o xi matel y 3 t o 5 m o nt hs i n t hese 
i n dicati o ns.
I n s u m mar y, d oceta xel is use d as a sta n dar d- of-care o pti o n f or sec o n d a n d later li nes of t hera p y 
f or m ulti ple s oli d t u m or t y pes after fr o ntli ne c he m ot hera p y a n d/ or i m m u ne c hec k p oi nt t hera p y.
1. 4.  
I nf or m ati o n A b o ut A u xili ar y Me dici n al Pr o d ucts 
Aceta mi n o p he n (als o k n o w n as paraceta m ol), di p he n h y dra mi ne, a n d de xa met has o ne are 
c o nsi dere d a u xiliar y me dici nal pr o d ucts ( A x M Ps) f or t his cli nical st u d y ( A p pe n di x 2 ). 
Aceta mi n o p he n is a p pr o ve d f or pai n relief a n d fe ver re d ucti o n. Di p he n h y dra mi ne is a n 
a nti hista mi ne a n d is a p pr o ve d f or a meli orati o n of aller gic reacti o ns. De xa met has o ne is a n 
a nti-i nfla m mat or y me dicati o n a n d is use d f or t he a meli orati o n of aller gic reacti o ns. T he use of 
t hese me dicati o ns i n t his st u d y is descri be d i n Secti o ns 5. 6  a n d 7. 8. 1. 2 . 
A d diti o nal details o n aceta mi n o p he n, di p he n h y dra mi ne, a n d de xa met has o ne ca n be f o u n d i n t he 
prescri bi n g i nf or mati o n.
1. 5.   
R ati o n ale f or T his St u d y
Str o n g n o ncli nical a n d cli nical rati o nale e xists f or c o m bi ni n g ma gr oli ma b wit h c he m ot hera p y 
a ge nts, i ncl u di n g ta xa nes. First, c he m ot hera pe utic a ge nts ha ve bee n de m o nstrate d t o e n ha nce 
pr o p ha g oc ytic si g nals o n t u m or cells t hat lea ds t o s y ner gistic a ntit u m or acti vit y w he n c o m bi ne d 
wit h ma gr oli ma b, a C D 4 7-tar geti n g a nti b o d y t hat bl oc ks t he a nti p ha g oc ytic si g nal. Si m ulta ne o us 
bl oc ka de of t he a nti p ha g oc ytic si g nal C D 4 7 b y ma gr oli ma b wit h u pre g ulati o n of pr o p ha g oc ytic 
si g nals via c he m ot hera pies ca n lea d t o s y ner gistic p ha g oc yt osis of t u m or cells b y macr o p ha ges. 
I n dee d, ma gr oli ma b c o m bi nati o n wit h ta xa nes ( paclita xel) le d t o e n ha nce d p ha g oc yt osis of s oli d 
t u m or cells i n vitr o a n d a statisticall y si g nifica nt re d ucti o n a n d eli mi nati o n of o varia n ca ncers i n 
vi v o, w he n c o m pare d t o si n gle-a ge nt t hera p y { Si kic 2 0 1 6 }. Cli nicall y, ma gr oli ma b has bee n 
c o m bi ne d wit h c yt ot o xic a ge nts a n d c he m ot hera p y (i ncl u di n g azaciti di ne, ge mcita bi ne, a n d 
o xali plati n) i n he mat ol o gic mali g na ncies i ncl u di n g A M L, M D S, a n d N H L. T hese a ge nts als o 
u pre g ulate pr o p ha g oc ytic si g nals a n d ha ve le d t o e n ha nce d c o m bi nati o n acti vit y wit h 

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 3 0
2 4 Oct o ber 2 0 2 3
ma gr oli ma b i n n o ncli nical m o dels. I n t he cli nical setti n g, ma gr oli ma b a n d azaciti di ne ha ve le d t o 
a 9 1 % O R R i n patie nts wit h u ntreate d hi g her ris k M D S a n d a 6 4 % O R R i n u ntreate d A M L 
patie nts { Sall ma n 2 0 2 0 }. C o m bi nati o n efficac y als o has bee n o bser ve d wit h ma gr oli ma b i n 
c o m bi nati o n wit h c he m ot hera pe utic a ge nts ( ge mcita bi ne, o xali plati n, a n d rit u xi ma b) i n patie nts 
wit h a d va nce d later li ne D L B C L. I m p orta ntl y, t he a d diti o n of ma gr oli ma b t o t hese 
c yt ot o xic/c he m ot hera pe utic a ge nts di d n ot ge nerall y e xacer bate t o xicities a n d t he c o m bi nati o n 
ha d a n acce pta ble safet y pr ofile wit h n o M T D reac he d ( Secti o n 1. 2. 3. 2 ).
1. 5. 1.  
S afet y R u n-i n C o h ort 1 a n d P h ase 2 C o h ort 1
Sta n dar d- of-care t hera p y f or ma n y ne wl y dia g n ose d metastatic s oli d t u m or ca ncers i ncl u de a 
plati n u m- base d c he m ot hera pe utic a ge nt a n d i m m u ne c hec k p oi nt i n hi bit or (ie, a nti- P D- 1/ P D- L 1 
a nti b o dies) w here a p plica ble. E nc o ura gi n g cli nical acti vit y has bee n see n s pecificall y wit h 
i m m u ne c hec k p oi nt i n hi bit ors as m o n ot hera p y or i n c o m bi nati o n wit h c he m ot hera p y i n t he 
fr o ntli ne setti n g a n d has dra maticall y i m pr o ve d res p o nse rates, P F S, a n d O S. H o we ver, patie nts 
wit h s oli d t u m ors w h o fail fr o ntli ne c he m ot hera pe utic re gi me ns a n d/ or i m m u ne c hec k p oi nt 
i n hi bit ors ha ve a p o or pr o g n osis wit h ge nerall y li mite d treat me nt o pti o ns. F or t he m ost part, 
si n gle-a ge nt or c o m bi nati o n c he m ot hera p y re prese nts t he maj or sta n dar d care o pti o n i n t he 
a d va nce d later li ne metastatic setti n g. F or ma n y s oli d t u m ors (i ncl u di n g t he s oli d t u m or t y pes 
e val uate d i n t his st u d y), ta xa nes re prese nt t he pre d o mi na nt sta n dar d- of-care c he m ot hera p y 
o pti o n p ost- plati n u m/i m m u ne c hec k p oi nt i n hi bit or t hera p y. W hile ta xa nes are mai nl y use d i n 
t hese i n dicati o ns p ost plati n u m- base d c he m ot hera p y a n d/ or i m m u ne c hec k p oi nt i n hi bit or t hera p y, 
t he cli nical acti vit y is m o dest. S pecificall y, t he O R Rs i n S C L C, U C, a n d N S C L C ra n ge fr o m 9 %, 
1 2. 4 %, a n d 1 3 %, res pecti vel y { Bell m u nt 2 0 1 7 , Ritt me yer 2 0 1 7 , S mit 1 9 9 8 }. Me dia n P F S i n 
t hese t u m or t y pes i n t his li ne of t hera p y is a p pr o xi matel y 3 t o 5 m o nt hs. T hese p o p ulati o ns 
t heref ore re prese nt a hi g h u n met me dical nee d. N o vel re gi me ns, es peciall y t h ose t hat ca n safel y 
a n d effecti vel y c o m bi ne wit h c he m ot hera p y, are nee de d t o i ncrease cli nical be nefit.
T he str o n g n o ncli nical a n d cli nical data s u p p ort t he e val uati o n of ma gr oli ma b i n c o m bi nati o n 
wit h c he m ot hera p y, i ncl u di n g ta xa nes, i n patie nts wit h a d va nce d later li ne s oli d t u m ors.
O ne of t he o bjecti ves of t his P hase 2 st u d y c o h ort is t o e val uate t he safet y, t olera bilit y, a n d 
rec o m me n de d P hase 2 d ose of ma gr oli ma b i n c o m bi nati o n wit h d oceta xel i n s oli d t u m ors. I n 
P hase 2 C o h ort 1, N S C L C, S C L C, a n d U C will be s pecificall y e val uate d f or efficac y gi ve n t hat 
ta xa nes re prese nt t he pre d o mi na nt sta n dar d- of-care c he m ot hera p y o pti o n i n t hese t u m or t y pes. 
D oceta xel was s pecificall y c h ose n gi ve n its hi g h usa ge patter n wit hi n ta xa nes i n t he U S a n d 
E ur o pe as well as t he lac k of a ntici pate d o verla p pi n g t o xicities.
I n s u m mar y, str o n g n o ncli nical a n d cli nical rati o nale e xists f or e val uati n g a c o m bi nati o n of 
ma gr oli ma b a n d d oceta xel i n s oli d t u m or mali g na ncies.
1. 6.   
R ati o n ale f or D ose Selecti o n of M a gr oli m a b
T he rati o nale f or t he ma gr oli ma b d ose pr o p ose d i n t his st u d y ori gi nates fr o m safet y, efficac y, 
a n d P K/ p har mac o d y na mic ( P D) data, a n d m o delli n g a n d si m ulati o n a nal yses base d o n data 
o btai ne d fr o m all o n g oi n g a n d c o m plete d cli nical st u dies wit h ma gr oli ma b i n patie nts wit h s oli d 
t u m ors, N H L, a n d A M L/ M D S.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 3 1
2 4 Oct o ber 2 0 2 3
I n t he first-i n- h u ma n st u d y of ma gr oli ma b ( S CI- C D 4 7- 0 0 1) i n patie nts wit h s oli d t u m ors a n d 
l y m p h o mas, after a n i nitial pri mi n g d ose of 1 m g/ k g o n t he first da y, ma gr oli ma b was teste d as a 
m o n ot hera p y at wee kl y d oses of u p t o 4 5 m g/ k g. T he use of a n i nitial 1 m g/ k g pri mi n g d ose was 
i nte grate d i nt o t he d osi n g re gi me n t o miti gate t he o n-tar get a ne mia i n d uce d b y C D 4 7 bl oc ka de. 
A n i nitial pri mi n g d ose lea ds t o eli mi nati o n of a ge d R B Cs t hat are se nsiti ve t o C D 4 7 bl oc ka de 
a n d tri g gers retic ul oc yt osis of y o u n g R B Cs t hat are n ot affecte d b y C D 4 7 bl oc ka de { C he n 
2 0 1 8 }. Utilizi n g a pri mi n g d ose lea ds t o a n i nitial, tra nsie nt, a n d mil d a ne mia t hat ge nerall y 
n or malizes bac k t o baseli ne o ver se veral wee ks, e ve n i n t he prese nce of re peate d t hera pe utic 
d oses of ma gr oli ma b { A d va ni 2 0 1 8 , Li u 2 0 1 5a , Si kic 2 0 1 9 }. 
I n a d diti o n, i n s oli d t u m ors w here t he c o m bi nati o n t hera p y (c he m ot hera p y or pe m br oliz u ma b) is 
gi ve n acc or di n g t o 3- wee k c ycles, d osi n g of ma gr oli ma b e ver y 3 wee ks o pti mizes patie nt a n d 
care gi ver c o n ve nie nce. Ma gr oli ma b 6 0 m g/ k g e ver y 3 wee ks is pre dicte d t o pr o vi de a si milar 
tr o u g h c o nce ntrati o n a n d R O as t he 3 0 m g/ k g e ver y 2 wee ks d ose, t he d ose bei n g use d i n 
P hase 3 st u dies i n A M L a n d M D S. Mai ntai ni n g a de q uate tr o u g h c o nce ntrati o n ma y be necessar y 
f or o pti mal efficac y c o nsi deri n g t hat s o me patie nts ma y e x perie nce d ose dela ys d ue t o t o xicit y. 
F urt her m ore, t he P K/ P D m o delli n g als o i n dicates t hat at t hese e xte n de d i nter val d osi n g 
re gi me ns, t he R O will be mai ntai ne d at ma xi mal le vels ( > 9 0 %) i n peri p heral bl o o d a n d t u m or 
tiss ues. T he pr o p ose d d osi n g re gi me n of ma gr oli ma b i n t his st u d y is e x pecte d t o ha ve a n 
acce pta ble safet y pr ofile base d o n t he e ntiret y of safet y data i n m ulti ple o nc ol o g y p o p ulati o ns, 
b ot h as a m o n ot hera p y a n d i n c o m bi nati o n wit h ot her t u m or-tar gete d a nti b o dies a n d 
c he m ot hera pe utics.
1. 6. 1.  
S afet y R u n-i n C o h ort 1 a n d P h ase 2 C o h ort 1
T he f oll o wi n g ma gr oli ma b d osi n g re gi me n is pr o p ose d f or Safet y R u n-i n C o h ort 1 a n d P hase 2 
C o h ort 1 o ver a 2 1- da y c ycle:
•
C ycle 1: pri mi n g ( 1 m g/ k g) o n Da y 1 a n d 3 0 m g/ k g o n Da ys 8 a n d 1 5
•
C ycle 2: wee kl y d oses of 3 0 m g/ k g o n Da ys 1, 8, a n d 1 5
•
C ycle 3 a n d o n war d: 6 0 m g/ k g e ver y c ycle o n Da y 1
1. 7.   
Ris k/ Be nefit Assess me nt f or t he St u d y
Patie nts wit h metastatic s oli d t u m ors w h o fail fr o ntli ne c o m bi nati o n c he m ot hera p y a n d/ or 
i m m u ne c hec k p oi nt i n hi bit or t hera p y ha ve li mite d treat me nt o pti o ns wit h a p o or pr o g n osis. I n 
ge neral, si n gle-a ge nt c he m ot hera p y (ie, ta xa nes) are utilize d i n t his setti n g acr oss se veral s oli d 
t u m or t y pes. H o we ver, res p o nse rates are a p pr o xi matel y 1 0 % wit h a li mite d me dia n O S. T h us, 
n o vel t hera pies t hat ca n safel y c o m bi ne wit h c he m ot hera p y t o e n ha nce efficac y are nee de d i n 
t his hi g h u n met nee d patie nt setti n g. 
Ma gr oli ma b ca n eli mi nate t u m or cells t hr o u g h macr o p ha ge- me diate d p ha g oc yt osis. Ma gr oli ma b 
acti vit y ca n be e n ha nce d wit h c he m ot hera pe utic a ge nts t hat ca n i ncrease pr o p ha g oc ytic si g nals 
o n t u m ors cells, lea di n g t o s y ner gistic p ha g oc yt osis. N o ncli nical data ha ve s h o w n t hat 
ma gr oli ma b i n c o m bi nati o n wit h ta xa nes lea d t o e n ha nce d p ha g oc yt osis of s oli d t u m or cells i n 

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 3 2
2 4 Oct o ber 2 0 2 3
vitr o a n d pr ol o n ge d re missi o ns i n xe n o graft m o dels c o m pare d t o si n gle-a ge nt t hera p y. 
F urt her m ore, cli nical st u d y data has s h o w n t hat ma gr oli ma b ca n e n ha nce efficac y of c yt ot o xic 
a ge nts i ncl u di n g a n o ver 9 0 % O R R i n patie nts wit h ne wl y dia g n ose d hi g her-ris k M D S wit h 
ma gr oli ma b i n c o m bi nati o n wit h azaciti di ne { Sall ma n 2 0 2 0 }. A c o m bi nati o n st u d y wit h 
ma gr oli ma b a n d tra diti o nal c he m ot hera p y ( ge mcita bi ne, o xali plati n, a n d rit u xi ma b) is o n g oi n g i n 
patie nts wit h N H L t hat has als o s h o w n i nitial si g ns of acti vit y a n d a n acce pta ble safet y pr ofile. 
T h us, t he scie ntific rati o nale, n o ncli nical, a n d cli nical data s u p p ort a c o m bi nati o n of ma gr oli ma b 
wit h ta xa ne c he m ot hera p y, i ncl u di n g d oceta xel.
Treat me nt wit h t he pr o p ose d c o m bi nati o n of ma gr oli ma b a n d d oceta xel f or s oli d t u m ors is n ot 
a ntici pate d t o p ose a si g nifica ntl y i ncrease d ris k t o patie nts e nr olle d i n t his trial c o m pare d t o t he 
ris k of treat me nt wit h eit her a ge nt al o ne. Base d o n t he cli nical pr ofiles of ma gr oli ma b a n d 
d oceta xel, o verla p pi n g t o xicities (e xce pt f or p ote ntial a ne mia) are n ot a ntici pate d wit h t he 
c o m bi nati o n. W hile ma gr oli ma b d oes ca use a tra nsie nt, ge nerall y mil d t o m o derate a ne mia, 
d oceta xel ge nerall y i n d uces Gra de 1 or 2 a ne mia i n patie nts. P ote ntial a ne mia o bser ve d is 
ma na ge d b y a pri mi n g/ mai nte na nce d ose re gi me n f or ma gr oli ma b, fre q ue nt la b orat or y 
m o nit ori n g of bl o o d c o u nts, a n d R B C tra nsf usi o n g ui da nce. I n a d diti o n t o a ne mia, ne utr o pe nia, 
t hr o m b oc yt o pe nia, a n d i nfecti o ns ha ve bee n re p orte d i n patie nts treate d wit h ma gr oli ma b. 
S pecific cli nical a n d la b orat or y m o nit ori n g of ma gr oli ma b- a n d d oceta xel-relate d t o xicities will 
be i m ple me nte d i n t his st u d y. F urt her m ore, ma gr oli ma b has bee n c o m bi ne d wit h c yt ot o xic 
c he m ot hera p y ( ge mcita bi ne, o xali plati n, a n d rit u xi ma b i n N H L patie nts) wit h o ut o bser vati o n of 
e xacer bati o n of c he m ot hera p y t o xicities, wit h a n acce pta ble safet y pr ofile, a n d wit h n o M T D 
reac he d. T h us, t he a ntici pate d safet y pr ofile of ma gr oli ma b wit h ta xa ne c o m bi nati o ns re prese nt 
a n acce pta ble ris k- be nefit rati o t o patie nts.
D uri n g a pa n de mic, a d diti o nal p ote ntial ris ks t o patie nts ma y i ncl u de a de q uate st u d y dr u g 
a vaila bilit y, i nterr u pti o ns t o t he st u d y visit sc he d ule, a n d a d here nce t o pr ot oc ol-s pecifie d safet y 
m o nit ori n g or la b orat or y assess me nts. Refer t o A p pe n di x 4  f or f urt her details o n t he ris ks a n d 
ris k miti gati o n strate g y.
I n s u m mar y, base d o n str o n g scie ntific rati o nale, n o ncli nical a n d e mer gi n g cli nical data, li mite d 
o verla p pi n g t o xicities, a n d t he ris k miti gati o n meas ures bei n g i m ple me nte d f or t he pa n de mic, t he 
e val uati o n of ma gr oli ma b i n c o m bi nati o n wit h d oceta xel i n patie nts wit h s oli d t u m ors is 
a ntici pate d t o ha ve a n acce pta ble ris k- be nefit rati o t o t he patie nts e nr olle d i n t his st u d y.
1. 8.   
C o m pli a nce
T his st u d y will be c o n d ucte d i n c o m plia nce wit h t his pr ot oc ol, G o o d Cli nical Practice ( G C P), 
a n d all a p plica ble re g ulat or y re q uire me nts.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 3 3
2 4 Oct o ber 2 0 2 3
2.   
O B J E C TI V E S A N D E N D P OI N T S
Ta ble 1  prese nts t he st u d y o bjecti ves a n d e n d p oi nts. T he a nal ysis of t he e n d p oi nts is descri be d i n 
Secti o n 8 .
T a ble 1.
G S- U S- 5 4 8- 5 9 1 8: St u d y O bjecti ves a n d E n d p oi nts
Pri m ar y O bjecti ves
Pri m ar y E n d p oi nts
• 
T o e val uate t he safet y, t olera bilit y, a n d 
rec o m me n de d P hase 2 d ose of ma gr oli ma b + 
d oceta xel c o m bi nati o n t hera p y i n s oli d t u m ors 
( Safet y R u n-i n C o h ort 1, P hase 2 C o h orts 1a, 
1 b, a n d 1c)
•
T o e val uate t he efficac y of ma gr oli ma b + 
d oceta xel c o m bi nati o n t hera p y i n s oli d t u m ors 
as deter mi ne d b y i n vesti gat or-assesse d 
o bjecti ve res p o nse rate ( O R R) ( P hase 2 
C o h orts 1a, 1 b, a n d 1c)
• 
I nci de nce of a d verse e ve nts ( A Es) a n d la b orat or y 
a b n or malities acc or di n g t o t he Nati o nal Ca ncer 
I nstit ute ( N CI) C o m m o n Ter mi n ol o g y Criteria f or 
A d verse E ve nts ( C T C A E), Versi o n 5. 0 ( A p pe n di x 5 ; 
Safet y R u n-i n C o h ort 1, P hase 2 C o h orts 1a, 1 b, a n d 
1c)
• 
O R R, defi ne d as t he pr o p orti o n of patie nts w h o 
ac hie ve a c o m plete res p o nse or partial res p o nse, as 
meas ure d b y Res p o nse E val uati o n Criteria i n S oli d 
T u m ors ( R E CI S T), Versi o n 1. 1, as deter mi ne d b y 
i n vesti gat or assess me nt ( P hase 2 C o h orts 1a, 1 b, a n d 
1c)
Sec o n d ar y O bjecti ves
Sec o n d ar y E n d p oi nts
• 
T o e val uate pr o gressi o n-free s ur vi val ( P F S) b y 
i n vesti gat or assess me nt ( P hase 2 C o h orts 1a, 
1 b, a n d 1c)
• 
T o e val uate a d diti o nal meas ures of efficac y of 
ma gr oli ma b + d oceta xel c o m bi nati o n t hera p y, 
i ncl u di n g d urati o n of res p o nse ( D O R) a n d 
o verall s ur vi val ( O S) ( P hase 2 C o h orts 1a, 1 b, 
a n d 1c)
•
T o e val uate t he P K a n d i m m u n o ge nicit y of 
ma gr oli ma b w he n gi ve n wit h d oceta xel as a 
c o m bi nati o n t hera p y ( Safet y R u n-i n C o h ort 1, 
P hase 2 C o h orts 1a, 1 b, a n d 1c)
• 
P F S fr o m date of d ose i nitiati o n as deter mi ne d b y 
i n vesti gat or assess me nt per R E CI S T, Versi o n 1. 1 
( P hase 2 C o h orts 1a, 1 b, a n d 1c)
• 
D O R, defi ne d as ti me fr o m first d oc u me ntati o n of 
c o m plete res p o nse or partial res p o nse t o t he earliest 
date of d oc u me nte d disease pr o gressi o n, per R E CI S T, 
Versi o n 1. 1, or deat h fr o m a n y ca use, w hic he ver 
occ urs first, as deter mi ne d b y i n vesti gat or assess me nt 
( P hase 2 C o h orts 1a, 1 b, a n d 1c)
• 
O S, defi ne d as date of d ose i nitiati o n ( P hase 2 
C o h orts 1a, 1 b, a n d 1c) t o deat h fr o m a n y ca use.
• 
Ma gr oli ma b c o nce ntrati o n vers us ti me a n d a nti dr u g 
a nti b o dies t o ma gr oli ma b ( Safet y R u n-i n C o h ort 1; 
P hase 2 C o h orts 1a, 1 b, a n d 1c)
C CI

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 3 4
2 4 Oct o ber 2 0 2 3
3.  
S T U D Y D E SI G N
3. 1.  
St u d y Desi g n
T his P hase 2, o pe n-la bel, m ultice nter, m ultiar m st u d y is e val uati n g ma gr oli ma b + d oceta xel 
c o m bi nati o n t hera p y f or patie nts wit h s oli d t u m ors. T his st u d y will c o nsist of t he f oll o wi n g 
Safet y R u n-i n C o h ort:
•
S afet y R u n-i n C o h ort 1:  ma gr oli ma b + d oceta xel c o m bi nati o n i n patie nts wit h s oli d t u m ors 
( m N S C L C, m U C, a n d m S C L C)
After c o m pleti o n of Safet y R u n-i n C o h ort 1, P hase 2 C o h ort 1 will occ ur as descri be d i n 
Secti o n 3. 1. 2 .
Patie nt partici pati o n will i ncl u de scree ni n g, treat me nt, a n d f oll o w- u p. Scree ni n g will last u p t o 
3 0 da ys bef ore first d ose of st u d y treat me nt, d uri n g w hic h ti me t he patie nt’s eli gi bilit y a n d 
baseli ne c haracteristics will be deter mi ne d. Patie nts will recei ve st u d y treat me nt per t he d ose 
sc he d ule i n A p pe n di x Ta ble 1 .
T he st u d y sc he matic is prese nte d i n Fi g ure 2 .
Fi g ure 2.
St u d y Sc he m a
m N S C L C = metastatic n o n –s mall cell l u n g ca ncer; m S C L C = metastatic s mall cell l u n g ca ncer; m U C = metastatic ur ot helial 
ca ncer; R P 2 D = rec o m me n de d P hase 2 d ose
S af et y  R u n-i n  C o h ort  1 
m N S C L C , m U C , m S C L C 
M a gr ol im a b  + 
D o c et a x el 
N = 1 8 
S a f et y E v a lu at i o n a n d R P 2 D 
P h a s e  2  C o h o rt  1 
( M a gr olim a b + D o c et a x e l ) 
P h a s e 2  C o h ort l a 
( m N S C L C) 
N = 3 0 
P h a s e 2  C o h ort l b 
( m U C) 
N =  2 6 
P h a s e 2  C o h ort l e 
( m S CLC) 
N = 4 0 

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 3 5
2 4 Oct o ber 2 0 2 3
3. 1. 1.  
S afet y R u n-i n C o h ort 1
A d ose ‑li miti n g t o xicit y ( D L T) e val uati o n peri o d of 1 c ycle ( 2 1 da ys) will occ ur. After 6 patie nts 
ha ve c o m plete d t he D L T e val uati o n peri o d, decisi o n will be ma de o n f urt her e x pa nsi o n or d ose 
de-escalati o n.
E ve n t h o u g h n o d ose- de pe n de nt t o xicities ha ve bee n o bser ve d wit h ma gr oli ma b, i n or der t o 
preser ve t he efficaci o us d oses of t he c o m bi nati o n part ner dr u gs, d ose de-escalati o n will ta ke 
place f or ma gr oli ma b as s pecifie d bel o w.
D ose de-escalati o n decisi o ns will be ma de as f oll o ws:
•
If 2 or fe wer of 6 D L T-e val ua ble patie nts e x perie nce a D L T i n C ycle 1, e nr oll me nt i nt o 
P hase 2 C o h ort 1 will be gi n at t his d ose le vel as t he rec o m me n de d P hase 2 d ose.
•
If m ore t ha n 2 patie nts e x perie nce at least 1 D L T d uri n g C ycle 1, e nr oll me nt at t he c urre nt 
d ose le vel will i m me diatel y st o p a n d d ose de-escalati o n will occ ur. U p t o a n ot her 6 patie nts 
will t he n be e nr olle d a n d e val uate d at a l o wer d ose le vel i n t he sa me ma n ner.
U p t o a p pr o xi matel y 1 8 patie nts c o ul d be p ote ntiall y e nr olle d a n d e val uate d d uri n g Safet y 
R u n-i n C o h ort 1.
D ose de-escalati o n f or Safet y R u n-i n C o h ort 1 is prese nte d i n Ta ble 2 . Base d o n t he t otalit y of 
t he data, alter nati ve d oses of ma gr oli ma b n ot descri be d i n Ta ble 2  ma y be c o nsi dere d f or d ose 
de-escalati o n b y t he Safet y Re vie w Tea m ( S R T) a n d s p o ns or.
3. 1. 1. 1.   
D L T Assess me nt Peri o d
T he D L T assess me nt peri o d will be t he first c ycle ( 2 1 da ys) a n d a p plies t o Safet y R u n-i n 
C o h ort 1. Patie nts are c o nsi dere d e val ua ble f or assess me nt of a D L T if eit her of t he f oll o wi n g 
criteria are met i n t he D L T assess me nt peri o d:
•
T he patie nt e x perie nce d a D L T at a n y ti me after i nitiati o n of t he first i nf usi o n of ma gr oli ma b.
•
T he patie nt di d n ot e x perie nce a D L T a n d c o m plete d at least 2 i nf usi o ns of ma gr oli ma b 
( 2 1- da y c ycle) a n d at least 1 d ose of d oceta xel i n Safet y R u n-i n C o h ort 1.
If a patie nt e x perie nces a D L T d uri n g t he D L T assess me nt peri o d, t he patie nt will disc o nti n ue 
treat me nt. T h o u g h t he d osi n g d uri n g mai nte na nce c ycles is hi g her, t he t otal d ose gi ve n d uri n g 
t he pri mi n g c ycle is hi g her t ha n t he mai nte na nce d ose. H o we ver, t he t otalit y of t he data o n safet y 
d uri n g a l o n ger f oll o w- u p will be ta ke n i nt o c o nsi derati o n w he n R P 2 D is deter mi ne d.
Patie nts w h o are n ot e val ua ble f or D L T assess me nt i n Safet y R u n-i n C o h ort 1 will be re place d.
3. 1. 1. 2.   
D L T Defi niti o n
All t o xicities will be gra de d acc or di n g t o t he Nati o nal Ca ncer I nstit ute ( N CI) C o m m o n 
Ter mi n ol o g y Criteria f or A d verse E ve nts ( C T C A E), Versi o n 5. 0 ( A p pe n di x 5 ). 

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 3 6
2 4 Oct o ber 2 0 2 3
A D L T is defi ne d as a n y:
•
Gra de 3 or hi g her he mat ol o gic t o xicit y.
•
E ve nt meeti n g H y’s La w criteria ( Secti o n 7. 7 ).
•
Gra de 3 or hi g her n o n he mat ol o gic t o xicit y t hat has w orse ne d i n se verit y fr o m pretreat me nt 
baseli ne d uri n g t he D L T assess me nt peri o d.
I n t he o pi ni o n of t he i n vesti gat or, t he A E is at least p ossi bl y relate d t o ma gr oli ma b.
T he f oll o wi n g are e xce pti o ns t o t he D L T defi niti o n a n d are N O T c o nsi dere d a D L T:
•
Gra de 3 a ne mia; h o we ver, Gra de 3 he m ol ytic a ne mia t hat is me dicall y si g nifica nt, re q uiri n g 
h os pitalizati o n or pr ol o n gati o n of e xisti n g h os pitalizati o n, disa bli n g, or li miti n g self-care 
acti vities of dail y li vi n g is c o nsi dere d a D L T.
•
Gra de 3 fe brile ne utr o pe nia t hat has res p o n de d cli nicall y wit hi n 7 2 h o urs of ma xi mal 
s u p p orti ve care.
•
Gra de 3 ne utr o pe nia t hat res ol ves t o Gra de 2 or pretreat me nt baseli ne wit h s u p p orti ve care 
(i ncl u di n g gr o wt h fact ors) wit hi n 1 4 da ys.
•
Gra de 3 i n direct/ u nc o nj u gate d h y per bilir u bi ne mia t hat res ol ves t o ≤ Gra de 2 wit h s u p p orti ve 
care wit hi n 1 wee k a n d is n ot ass ociate d wit h ot her cli nicall y si g nifica nt c o nse q ue nces.
•
Gra de 3 electr ol yte a b n or malities t hat i m pr o ve t o ≤ Gra de 2 or baseli ne wit hi n < 7 2 h o urs, 
are n ot cli nicall y c o m plicate d, a n d res ol ve s p o nta ne o usl y or res p o n d t o c o n ve nti o nal me dical 
i nter ve nti o ns.
•
Gra de 3 ele vati o n i n ala ni ne a mi n otra nsferase ( A L T), as partate a mi n otra nsferase ( A S T), or 
al kali ne p h os p hatase t hat res ol ves t o ≤ Gra de 2 wit h s u p p orti ve care wit hi n 1 wee k a n d is n ot 
ass ociate d wit h ot her cli nicall y si g nifica nt c o nse q ue nces.
•
Gra de 3 na usea/ v o miti n g or diarr hea t hat res ol ves t o ≤ Gra de 2 wit hi n 7 2 h o urs wit h 
a de q uate a ntie metic a n d ot her s u p p orti ve care.
•
Gra de 3 fati g ue t hat res ol ves t o ≤ Gra de 2 wit hi n 1 wee k o n st u d y.
•
Gra de 3 ma gr oli ma b a n d d oceta xel i nf usi o n reacti o ns i n t he a bse nce of a n o pti mal 
pretreat me nt re gi me n, w hic h is defi ne d as aceta mi n o p he n or a c o m para ble n o nster oi dal 
a nti-i nfla m mat or y a ge nt, pl us a n a nti hista mi ne a n d c ortic oster oi ds.
•
Gra de 3 t u m or l ysis s y n dr o me or electr ol yte dist ur ba nces ( h y per kale mia, h y p o p h os p hate mia, 
h y per urice mia) t hat res ol ve t o ≤ Gra de 2 or baseli ne wit hi n 7 2 h o urs.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 3 7
2 4 Oct o ber 2 0 2 3
•
Gra de 3 or 4 l y m p h o pe nia or le u k o pe nia n ot ass ociate d wit h ot her cli nicall y si g nifica nt 
c o nse q ue nces.
•
Tra nsie nt ( ≤ 4 8 h o urs) Gra de 3 l ocal reacti o ns, fl u-li ke s y m pt o ms, m yal gias, fe ver, hea dac he, 
ac ute pai n, or s ki n t o xicit y t hat res ol ves t o ≤ Gra de 2 wit hi n 7 2 h o urs after me dical 
ma na ge me nt (e g, s u p p orti ve care, i ncl u di n g i m m u n os u p pressa nt treat me nt) has bee n 
i nitiate d.
T he rec o m me n de d d ose f or P hase 2 C o h ort 1 will be deter mi ne d b y t he s p o ns or base d o n all 
rele va nt cli nical a n d P K data (a d diti o nal data s uc h as bi o mar kers ma y als o be c o nsi dere d) fr o m 
all patie nts treate d i n t he Safet y R u n-i n P hase.
3. 1. 1. 3.  
Safet y Re vie w Tea m
A n S R T will be esta blis he d t o assess safet y of t he patie nts i n vari o us c o h orts.
T he S R T will i ncl u de at least 1 i n vesti gat or, a Gilea d Safet y P h ysicia n, a n d t he Gilea d me dical 
m o nit or. Ot hers ma y be i n vite d t o partici pate as me m bers of t he S R T if a d diti o nal e x pertise is 
desire d. T he me dical m o nit or ser ves as t he c hair of t he S R T. A n S R T c harter ( or si milar 
d oc u me nt) will be a gree d o n b y all S R T me m bers pri or t o t he first S R T meeti n g. T he data 
re vie we d at t he S R T meeti n g t o ma ke decisi o ns will be defi ne d i n t he S R T c harter ( or si milar 
d oc u me nt). T he q ualit y c o ntr ol c hec ks perf or me d o n t he data re vie we d a n d use d f or ma ki n g 
decisi o ns will be descri be d i n t he S R T c harter ( or si milar d oc u me nt).
3. 1. 2.  
P h ase 2 C o h ort 1
After c o m pleti o n of t he Safet y R u n-i n C o h ort, P hase 2 C o h ort 1 will occ ur as f oll o ws:
•
P h ase 2 C o h ort 1:  a c o h ort of patie nts wit h s oli d t u m ors ( m N S C L C [ P hase 2 C o h ort 1a], 
m U C [ P hase 2 C o h ort 1 b], a n d m S C L C [ P hase 2 C o h ort 1c]).
O nce Safet y R u n-i n C o h ort 1 is c o m plete d a n d t he rec o m me n de d d ose f or P hase 2 C o h ort 1 is 
deter mi ne d, t he s p o ns or will o pe n P hase 2 C o h ort 1. P hase 2 C o h ort 1 will treat u p t o 3 0 patie nts 
wit h m N S C L C ( P hase 2 C o h ort 1a), u p t o 2 6 patie nts wit h m U C ( P hase 2 C o h ort 1 b), a n d u p t o 
4 0 patie nts wit h m S C L C ( P hase 2 C o h ort 1c) t o e val uate efficac y.
3. 2.  
St u d y Tre at me nts
3. 2. 1.  
S afet y R u n-i n C o h ort 1 a n d P h ase 2 C o h ort 1
Ta ble 2  s h o ws t he st u d y treat me nts f or Safet y R u n-i n C o h ort 1 a n d Ta ble 3  s h o ws t he st u d y 
treat me nts f or P hase 2 C o h ort 1. T he sc he d ules of assess me nt are pr o vi de d i n A p pe n di x 3 .

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 3 8
2 4 Oct o ber 2 0 2 3
T a ble 2.
S afet y R u n-i n C o h ort 1: D ose Le vel, Sc he d ule, a n d De-esc al ati o n
D osi n g ( C ycles Are 2 1 D a ys)
Dr u g
D ose Le vel
C ycle 1
C ycle 2
C ycle 3 + 
( m ai nte n a nce 
d osi n g)
Starti n g d ose
3 0 m g/ k g
1 m g/ k g I V ( 3 h ± 3 0 mi n) 
o n Da y 1 ( pri mi n g d ose), 
3 0 m g/ k g I V ( 2 h ± 3 0 mi n) 
o n Da ys 8 a n d 1 5
3 0 m g/ k g I V ( 2 h ± 
3 0 mi n) o n Da ys 1, 
8, a n d 1 5
6 0 m g/ k g I V 
( 2 h ± 3 0 mi n) o n 
Da y 1
De-escalati o n
Le vel −1
2 0 m g/ k g
1 m g/ k g I V ( 3 h ± 3 0 mi n) 
o n Da y 1 ( pri mi n g d ose); 
2 0 m g/ k g I V ( 2 h ± 3 0 mi n) 
o n Da ys 8 a n d 1 5
2 0 m g/ k g I V ( 2 h ± 
3 0 mi n) o n Da ys 1, 
8, a n d 1 5
4 5 m g/ k g I V 
( 2 h ± 3 0 mi n) o n 
Da y 1
Ma gr oli ma b
De-escalati o n
Le vel −2
1 5 m g/ k g
1 m g/ k g I V ( 3 h ± 3 0 mi n) 
o n Da y 1 ( pri mi n g d ose); 
1 5 m g/ k g I V ( 2 h ± 3 0 mi n) 
o n Da ys 8 a n d 1 5
1 5 m g/ k g I V ( 2 h ± 
3 0 mi n) o n Da ys 1, 
8, a n d 1 5
3 0 m g/ k g I V 
( 2 h ± 3 0 mi n) o n 
Da y 1
D oceta xel
7 5 m g/ m 2
7 5 m g/ m 2 I V ( 1 h ± 5 mi n) 
o n Da y 1
7 5 m g/ m 2 I V ( 1 h ± 
5 mi n) o n Da y 1
7 5 m g/ m 2 I V 
( 1 h ± 5 mi n) o n 
Da y 1
I V = i ntra ve n o us
T a ble 3.
P h ase 2 C o h ort 1: D ose Le vel a n d Sc he d ule
D osi n g ( C ycles Are 2 1 D a ys)
Dr u g
R P 2 D a
St arti n g D ose
C ycle 1
C ycle 2
C ycle 3 + 
( m ai nte n a nce 
d osi n g)
3 0 m g/ k g
1 m g/ k g I V ( 3 h ± 3 0 mi n) 
o n Da y 1 ( pri mi n g d ose); 
3 0 m g/ k g I V ( 2 h ± 3 0 mi n) 
o n Da ys 8 a n d 1 5
3 0 m g/ k g I V 
( 2 h ± 3 0 mi n) o n 
Da ys 1, 8, a n d 1 5
6 0 m g/ k g I V 
( 2 h ± 3 0 mi n) o n 
Da y 1
O R
2 0 m g/ k g
1 m g/ k g I V ( 3 h ± 3 0 mi n) 
o n Da y 1 ( pri mi n g d ose); 
2 0 m g/ k g I V ( 2 h ± 3 0 mi n) 
o n Da ys 8 a n d 1 5
2 0 m g/ k g I V 
( 2 h ± 3 0 mi n) o n 
Da ys 1, 8, a n d 1 5 
4 5 m g/ k g I V 
( 2 h ± 3 0 mi n) o n 
Da y 1
Ma gr oli ma b
O R
1 5 m g/ k g
1 m g/ k g I V ( 3 h ± 3 0 mi n) 
o n Da y 1 ( pri mi n g d ose); 
1 5 m g/ k g I V ( 2 h ± 3 0 mi n) 
o n Da ys 8 a n d 1 5
1 5 m g/ k g I V 
( 2 h ± 3 0 mi n) o n 
Da ys 1, 8, a n d 1 5
3 0 m g/ k g I V 
( 2 h ± 3 0 mi n) o n 
Da y 1
D oceta xel
7 5 m g/ m 2 I V 
7 5 m g/ m 2 I V ( 1 h ± 5 mi n) 
o n Da y 1
7 5 m g/ m 2 I V 
( 1 h ± 5 mi n) o n 
Da y 1
7 5 m g/ m 2 I V 
( 1 h ± 5 mi n) o n 
Da y 1
I V = i ntra ve n o us; R P 2 D = rec o m me n de d P hase 2 d ose
a  
R P 2 D as deter mi ne d i n Safet y R u n-i n C o h ort 1.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 3 9
2 4 Oct o ber 2 0 2 3
3. 3.   
D ur ati o n of Tre at me nt
C ycle le n gt hs are 2 1 da ys f or Safet y R u n-i n C o h ort 1 a n d P hase 2 C o h ort 1. Patie nts ma y 
c o nti n ue treat me nt u nless t he y de vel o p u nacce pta ble t o xicit y t hat ca n n ot be cli nicall y ma na ge d 
b y d ose or sc he d ule m o dificati o ns or if t he y ha ve c o nfir me d pr o gressi ve disease acc or di n g t o 
R E CI S T, Versi o n 1. 1. Patie nts are n ot re q uire d t o disc o nti n ue st u d y dr u gs f or disease 
pr o gressi o n per R E CI S T criteria, gi ve n t he o bser vati o n t hat dela ye d cli nical be nefit ca n occ ur 
wit h i m m u ne t hera pies be y o n d i nitial disease pr o gressi o n. Ma gr oli ma b ca n be c o nti n ue d if t he 
c o m bi nati o n part ner dr u g (ie, d oceta xel) is disc o nti n ue d f or u nacce pta ble t o xicit y. C o m bi nati o n 
part ner dr u g ca n be c o nti n ue d if ma gr oli ma b is disc o nti n ue d f or u nacce pta ble t o xicit y. St u d y 
dr u g treat me nt ma y c o nti n ue past t he i nitial deter mi nati o n of disease pr o gressi o n acc or di n g t o 
R E CI S T, Versi o n 1. 1 if t he f oll o wi n g criteria are met:
•
N o ne w s y m pt o ms or w orse ni n g of pre vi o us s y m pt o ms
•
T olera nce of ma gr oli ma b a n d d oceta xel
•
Sta ble Easter n C o o perati ve O nc ol o g y Gr o u p ( E C O G) perf or ma nce stat us
•
Treat me nt be y o n d pr o gressi o n will n ot dela y a n i m mi ne nt i nter ve nti o n t o pre ve nt seri o us 
c o m plicati o ns of disease pr o gressi o n (f or e xa m ple, ce ntral ner v o us metastases).
T he decisi o n t o c o nti n ue treat me nt s h o ul d be a p pr o ve d b y t he s p o ns or. Patie nts w h o c o nti n ue 
st u d y dr u g treat me nt past t he i nitial deter mi nati o n of disease pr o gressi o n will be re q uire d t o 
re-c o nse nt t o t he c o nti n ue d treat me nt.
3. 4.   
Disc o nti n u ati o n Criteri a
Reas o ns f or disc o nti n uati o n of st u d y treat me nt ma y i ncl u de, b ut are n ot li mite d t o, t he f oll o wi n g:
•
Disease pr o gressi o n b y R E CI S T, Versi o n 1. 1 (treat me nt be y o n d disease pr o gressi o n b y 
R E CI S T, Versi o n 1. 1 is all o we d per criteria i n Secti o n 3. 3 )
•
U nacce pta ble t o xicit y
•
L oss of cli nical be nefit
•
Cli nicall y si g nifica nt c ha n ge i n t he patie nt’s stat us t hat precl u des f urt her treat me nt 
(e g, pre g na nc y or ot her A Es)
•
Patie nt re q uest, wit h or wit h o ut a state d reas o n
•
Patie nt n o nc o m plia nce
•
Disc o nti n uati o n of t he st u d y at t he re q uest of Gilea d, a re g ulat or y a ge nc y or a n i nstit uti o nal 
re vie w b oar d (I R B) or i n de pe n de nt et hics c o m mittee (I E C)
•
I n vesti gat or or treati n g p h ysicia n decisi o n i n t he a bse nce of a n y of t he a b o ve

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 4 0
2 4 Oct o ber 2 0 2 3
Alt h o u g h disease pr o gressi o n is c o nsi dere d a s ufficie nt reas o n f or disc o nti n ui n g a patie nt fr o m 
st u d y treat me nt, gi ve n t he dela ye d treat me nt be nefit c o m m o nl y see n i n i m m u ne t hera pies, t he 
i n vesti gat or is a d vise d t o c o nti n ue t o treat t he patie nt u ntil t he c o nfir mati o n of disease 
pr o gressi o n t hr o u g h a s u bse q ue nt res p o nse assess me nt at least 4 wee ks a part (ie, disease 
w orse ni n g c o m pare d t o t he pre vi o us assess me nt), or u ntil t he i n vesti gat or c o nsi ders t he st u d y 
treat me nt t o be n o l o n ger cli nicall y be neficial t o t he patie nt, or t he c ha n ge of disease state 
re n ders t he patie nt u nacce pta ble f or f urt her treat me nt i n t he j u d g me nt of t he i n vesti gat or. Patie nts 
ma y c o nti n ue st u d y dr u g treat me nt be y o n d R E CI S T, Versi o n 1. 1 disease pr o gressi o n as per 
criteria i n Secti o n 3. 3 . All patie nts m ust be f oll o we d t hr o u g h c o m pleti o n of all st u d y treat me nt.
3. 5.   
Disc o nti n u ati o n Fr o m St u d y Criteri a/ E n d of St u d y
All P atie nts : T he e n d of t he e ntire st u d y f or all patie nts is defi ne d as t he date o n w hic h t he last 
patie nt re mai ni n g o n st u d y c o m pletes t he last st u d y visit/call or w he n t he s p o ns or deci des t o e n d 
t he st u d y. T he s p o ns or reser ves t he ri g ht t o ter mi nate t he st u d y at a n y ti me f or a n y reas o n 
(i ncl u di n g safet y).
I n di vi d u al P atie nts: Patie nts are c o nsi dere d t o ha ve c o m plete d st u d y partici pati o n alt o get her 
w he n t he y are n o l o n ger f oll o we d f or s ur vi val.
All patie nts will be f oll o we d f or s ur vi val u ntil deat h, wit h dra w fr o m c o nse nt, l ost t o f oll o w- u p, 
a n d t he e n d of st u d y, w hic he ver occ urs first.
F or a n y patie nt w h o dies d uri n g t his f oll o w- u p peri o d, t he i m me diate ca use of deat h m ust be 
re p orte d t o t he s p o ns or.
3. 6.  
P ostst u d y C are
U p o n wit h dra wal fr o m st u d y treat me nt, patie nts will recei ve t he care u p o n w hic h t he y a n d t heir 
p h ysicia ns a gree. Patie nts will be f oll o we d f or disease pr o gressi o n if a p plica ble, s ur vi val, a n d 
A Es as s pecifie d i n A p pe n di x Ta ble 2 .
3. 7.  
S o urce D at a
T he s o urce data f or t his st u d y will be o btai ne d fr o m ori gi nal rec or ds (e g, cli nic n otes, h os pital 
rec or ds, patie nt c harts), ce ntral la b orat or y, l ocal la b orat or y, a n d/ or s pecialt y la b orat or y (f or P K, 
A D A, a n d/ or P D data) a n d/ or a d diti o nal bi o mar ker testi n g, a n d I nteracti ve Res p o nse Tec h n ol o g y 
(I R T).
3. 8.  
Bi o m ar ker S a m ples t o A d dress t he St u d y O bjecti ves
Peri p heral bl o o d a n d t u m or bi o ps y  sa m ples will be c ollecte d fr o m all patie nts w h o ha ve pr o vi de d 
c o nse nt t o partici pate i n t his st u d y. T he y ma y be use d t o e val uate t he ass ociati o n of s yste mic 
a n d/ or tiss ue- base d bi o mar kers wit h st u d y dr u g res p o nse, i ncl u di n g efficac y a n d/ or A Es, d osa ge 
selecti o n, a n d t o better u n dersta n d t he bi ol o g y of t he ca ncer i n dicati o ns st u die d, as well as t he 
efficac y a n d M O A f or ma gr oli ma b c o m bi nati o ns. Beca use bi o mar ker scie nce is a ra pi dl y 
e v ol vi n g area of i n vesti gati o n, a n d A Es, i n partic ular, are diffic ult t o pre dict, it ma y n ot be 
p ossi ble t o s pecif y pr os pecti vel y all tests t hat ma y be d o ne o n t he s peci me ns pr o vi de d. T he 

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 4 1
2 4 Oct o ber 2 0 2 3
s pecific a nal yses will i ncl u de, b ut ma y n ot be li mite d t o, t he bi o mar kers a n d assa ys descri be d 
bel o w. T he testi n g o utli ne d bel o w is base d u p o n t he c urre nt state of scie ntific k n o wle d ge. It ma y 
be m o difie d d uri n g or after t he e n d of t he st u d y t o re m o ve tests n o l o n ger i n dicate d a n d/ or t o a d d 
ne w tests base d u p o n ne w state- of-t he-art k n o wle d ge.
Bi o mar ker assess me nts will i ncl u de:
•
Bl o o d sa m ple f or R O at select sites
•
Peri p heral bl o o d m o n o n uclear cell ( P B M C) t o assess i m m u ne cell p he n ot y pes (at selecte d 
sites)
•
Ser u m a n d plas ma bi o mar ker sa m ples f or t he a nal ysis of circ ulati n g fact ors s uc h as 
c yt o ki nes, s ol u ble i m m u ne rece pt ors, a n d a nti b o dies
•
W h ole bl o o d R N A sa m ples f or le u k oc yte ge ne e x pressi o n a nal ysis
•
I m m u n o p he n ot y pi n g assa y
•
T-cell rece pt or se q ue nci n g sa m ple t o assess i m m u ne re pert oire c ha n ges
•
Circ ulati n g t u m or D N A sa m ple t o m o nit or treat me nt res p o nse
•
St o ol sa m ples t o assess micr o bi o me
•
Ma n dat or y baseli ne t u m or tiss ue a n d o n treat me nt bi o psies t o assess i m m u ne cells, t u m or cell 
s urface pr otei ns, a n d/ or ge n o mic bi o mar kers
Bl o o d a n d t u m or bi o ps y sa m ples will be c ollecte d t o meas ure bi o mar kers, w hic h ma y i ncl u de 
b ut will n ot be li mite d t o t he prese nce of or c ha n ges t o i m m u ne cell p o p ulati o ns, secrete d pr otei n 
fact ors, t he e x pressi o n of cell s urface mar kers o n eit her t u m or cells or cells of t he t u m or 
micr oe n vir o n me nt, a n d ge netic m utati o ns i n t u m or cells or s u bcl o nes of t u m or cells at t he ti me 
p oi nts liste d i n t he sc he d ules of assess me nts ( A p pe n di x Ta ble 3 ). 
Bl o o d a n d t u m or sa m ples will als o be use d f or ge n o mic researc h. I n a d diti o n, a w h ole bl o o d 
sa m ple will be c ollecte d at C ycle 1 Da y 1 b ut ma y be c ollecte d at a n y ti me d uri n g t he st u d y, if 
necessar y. T hese sa m ples will be use d t o i de ntif y or vali date ge netic mar kers t hat ma y i ncrease 
o ur k n o wle d ge a n d u n dersta n di n g of t he bi ol o g y of t he st u d y disease a n d relate d diseases a n d t o 
st u d y t he ass ociati o n of ge netic mar kers wit h disease pat h o ge nesis, pr o gressi o n, a n d/ or treat me nt 
o utc o mes, i ncl u di n g efficac y, A Es, a n d t he pr ocesses of dr u g a bs or pti o n a n d dis p ositi o n. T hese 
s peci me ns ma y als o be use d t o de vel o p bi o mar ker or dia g n ostic assa ys a n d esta blis h t he 
perf or ma nce c haracteristics of t hese assa ys. Ge n o mics researc h ma y i ncl u de se q ue nci n g of 
ge netic material deri ve d fr o m b ot h ca ncer cells a n d n or mal cells. Se q ue nci n g of ge netic material 
deri ve d fr o m ca ncer cells will be use d t o better u n dersta n d t he M O A of ma gr oli ma b 
c o m bi nati o ns i n t his patie nt p o p ulati o n a n d t o p ote ntiall y t o i de ntif y s u bsets of patie nts w h o are 
li kel y t o be nefit. Se q ue nci n g of ge netic material deri ve d fr o m n or mal cells will be use d t o defi ne 
differe nces i n se q ue nce t hat are ca ncer s pecific.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 4 2
2 4 Oct o ber 2 0 2 3
Sa m ples c ollecte d f or bi o mar ker assess me nts will be destr o ye d n o later t ha n 1 5 years after t he 
e n d of st u d y or per c o u ntr y re q uire me nts.
3. 8. 1.  
P h ar m ac o ki netics/ Bi o m ar ker S a m ples f or 
I n a d diti o n t o t he st u d y-s pecific i nf or me d c o nse nt t o be si g ne d b y eac h patie nt partici pati n g i n 
t he st u d y, patie nts will be re q uire d t o d oc u me nt a gree me nt t o all o w t he use of t he re mai n der of 
t heir alrea d y c ollecte d bi o mar ker a n d P K s peci me ns f or 
, i n acc or da nce 
wit h a p plica ble re g ulati o ns.
T he re mai n der of t heir alrea d y c ollecte d s peci me ns f or
 ma y be use d t o 
a d va nce de vel o p me nt of t he dr u g a n d/ or i ncrease o ur k n o wle d ge a n d u n dersta n di n g of t he 
bi ol o g y of t he disease u n der i n vesti gati o n a n d relate d diseases. T hese s peci me ns ma y als o be 
use d t o st u d y t he ass ociati o n of bi o mar kers wit h bi ol o gical pat h wa ys, disease pat h o ge nesis, 
pr o gressi o n a n d/ or treat me nt o utc o mes, i ncl u di n g efficac y, A Es, a n d t he pr ocesses of dr u g 
a bs or pti o n a n d dis p ositi o n. I n a d diti o n, t hese s peci me ns ma y be use d t o de vel o p bi o mar ker 
a n d/ or dia g n ostic assa ys a n d esta blis h t he perf or ma nce c haracteristics of t hese assa ys. T he 
a nal ysis of 
 s peci me ns ma y facilitate t he desi g n of ne w p har mace utical 
a ge nts a n d t he de vel o p me nt of dia g n ostic tests, w hic h ma y all o w f or i n di vi d ualize d dr u g t hera p y 
f or patie nts 
Bl o o d sa m ples will be c ollecte d t o meas ure bi o mar kers w hic h ma y i ncl u de b ut n ot be li mite d t o 
t he ti mes p oi nts s pecifie d i n t he sc he d ules of assess me nts (A p pe n di x Ta ble 3 ). 
T he alrea d y c ollecte d s peci me ns f or 
 will be destr o ye d n o later t ha n 
1 5 years after t he e n d of st u d y or per c o u ntr y re q uire me nts.
C CI
C CI
C CI
C CI
C CI
C CI

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 4 3
2 4 Oct o ber 2 0 2 3
4.  
P A TI E N T P O P U L A TI O N
4. 1.   
N u m ber of P atie nts a n d P atie nt Selecti o n
U p t o a p pr o xi matel y 1 1 4 patie nts ma y be e nr olle d i n t he st u d y, wit h u p t o a p pr o xi matel y 
1 8 patie nts i n Safet y R u n-i n C o h ort 1 a n d  u p t o a p pr o xi matel y 9 6 patie nts i n P hase 2 C o h ort 1.
4. 1. 1.  
P atie nt Re pl ace me nt
Patie nts ma y be re place d d uri n g t he Safet y R u n-i n C o h ort if n ot e val ua ble f or D L T assess me nt 
as descri be d i n Secti o n 3. 1. 1 .
4. 2.  
I ncl usi o n Criteri a
All patie nts m ust meet all of t he f oll o wi n g i ncl usi o n criteria t o be eli gi ble f or partici pati o n i n t his 
st u d y:
1)
Patie nt has pr o vi de d i nf or me d c o nse nt.
2)
Patie nt is willi n g a n d a ble t o c o m pl y wit h cli nic visits a n d pr oce d ures o utli ne d i n t he st u d y 
pr ot oc ol.
3)
Male or fe male, ≥ 1 8 years of a ge
4)
Patie nts m ust ha ve a n E C O G perf or ma nce stat us of ≤ 2.
5)
La b orat or y meas ure me nts, bl o o d c o u nts:
a)
He m o gl o bi n m ust be ≥ 9 g/ d L pri or t o i nitial d ose of st u d y dr u g. N O T E: Tra nsf usi o ns are 
all o we d t o meet eli gi bilit y (see Secti o n 7. 8. 1. 1. 1  a n d e xcl usi o n criteri o n 4).
b)
A bs ol ute ne utr o p hil c o u nt ( A N C) ≥ 1. 5  1 09/ L
c)
Platelets ≥ 1 0 0  1 09/ L
6)
La b orat or y meas ure me nts, re nal f u ncti o n:
a)
Patie nts m ust ha ve a de q uate re nal f u ncti o n as de m o nstrate d b y a creati ni ne cleara nce of 
at least 3 0 m L/ mi n; calc ulate d b y t he C oc kcr oft Ga ult f or m ula.
7)
A de q uate li ver f u ncti o n, as de m o nstrate d b y:
a)
A S T less t ha n or e q ual t o 2. 5  u p per li mit of n or mal ( U L N) or less t ha n or e q ual t o 
5  U L N i n patie nts wit h li ver metastases
b)
A L T less t ha n or e q ual t o 2. 5  U L N or less t ha n or e q ual t o 5  U L N i n patie nts wit h 
li ver metastases

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 4 4
2 4 Oct o ber 2 0 2 3
c)
Bilir u bi n less t ha n or e q ual t o 1. 5  U L N, or less t ha n or e q ual t o 3. 0  U L N a n d 
pri maril y u nc o nj u gate d if patie nt has a d oc u me nte d hist or y of Gil bert’s s y n dr o me or 
ge netic e q ui vale nt
8)
Pretreat me nt bl o o d cr oss- matc h c o m plete d (see Secti o n 7. 8. 1. 1. 1 )
9) 
Male a n d fe male patie nts of c hil d beari n g p ote ntial w h o e n ga ge i n heter ose x ual i nterc o urse 
m ust a gree t o use pr ot oc ol-s pecifie d met h o d(s) of c o ntrace pti o n as descri be d i n A p pe n di x 6 .
1 0) Meas ura ble disease acc or di n g t o R E CI S T, Versi o n 1. 1. Pre vi o usl y irra diate d lesi o ns ca n be 
c o nsi dere d as meas ura ble disease o nl y if disease pr o gressi o n has bee n u ne q ui v ocall y 
d oc u me nte d at t hat site si nce ra diati o n.
1 1) Criteri o n re m o ve d.
C o h ort- S pecific I ncl usi o n Criteri a
Patie nts nee d t o f ulfill t he f oll o wi n g c o h ort-s pecific criteria, i n a d diti o n t o satisf yi n g t he 
i ncl usi o n criteria f or all patie nts:
1 2) Criteri o n re m o ve d.
1 3) Criteri o n re m o ve d.
1 4) Safet y R u n-i n C o h ort 1: Patie nts wit h metastatic a d va nce d s oli d t u m ors w h o ha ve ha d at least 
1 pri or li ne of s yste mic a ntica ncer t hera p y ( m N S C L C a n d m S C L C) i n a l ocall y 
a d va nce d/ metastatic setti n g, or 2 pri or li nes of s yste mic a ntica ncer t hera p y ( m U C) i n a 
l ocall y a d va nce d/ metastatic setti n g, a n d n ot m ore t ha n 3 pri or li nes of s yste mic a ntica ncer 
t hera p y i n a l ocall y a d va nce d/ metastatic setti n g.
1 5) P hase 2 C o h ort 1a ( m N S C L C): Patie nts wit h N S C L C w h o ha ve ha d treat me nt wit h plati n u m 
- base d c he m ot hera p y a n d i m m u ne c hec k p oi nt i n hi bit or t hera p y i n a l ocall y 
a d va nce d/ metastatic setti n g, eit her i n c o m bi nati o n or se q ue ntiall y ( u nless n ot eli gi ble f or o ne 
of t hese t hera pies) are eli gi ble. At least 1 pri or li ne of s yste mic a ntica ncer t hera p y i n a l ocall y 
a d va nce d/ metastatic setti n g is re q uire d a n d n ot m ore t ha n 2 pri or li nes of s yste mic a ntica ncer 
t hera p y i n a l ocall y a d va nce d/ metastatic setti n g are all o we d. Patie nts treate d wit h a ta xa ne 
wit hi n 1 2 m o nt hs or patie nts refract or y t o pri or ta xa ne treat me nt are e xcl u de d. Patie nts 
w h ose t u m ors ha ve ge n o mic alterati o ns f or w hic h t here are a p pr o ve d t hera pies (e g, E G F R, 
R O S 1, A L K, N T R K, M E T e x o n 1 4) are e xcl u de d. 
1 6) P hase 2 C o h ort 1 b ( m U C): Patie nts wit h U C w h o ha ve ha d pri or treat me nt wit h s yste mic 
c he m ot hera p y a n d i m m u ne c hec k p oi nt i n hi bit or t hera p y i n a l ocall y a d va nce d/ metastatic 
setti n g ( u nless n ot eli gi ble f or o ne of t hese t hera pies) are eli gi ble. At least 2 pri or li nes of 
s yste mic a ntica ncer t hera p y i n a l ocall y a d va nce d/ metastatic setti n g are re q uire d a n d n ot 
m ore t ha n 3 pri or li nes of s yste mic a ntica ncer t hera p y i n a l ocall y a d va nce d/ metastatic 
setti n g are all o we d. Patie nts treate d wit h a ta xa ne wit hi n 1 2 m o nt hs or patie nts refract or y t o 
pri or ta xa ne treat me nt are e xcl u de d.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 4 5
2 4 Oct o ber 2 0 2 3
1 7) P hase 2 C o h ort 1c ( m S C L C): Patie nts wit h S C L C w h o ha ve ha d pri or treat me nt wit h 
plati n u m- base d c he m ot hera p y wit h or wit h o ut i m m u n ot hera p y are eli gi ble. At least 1 pri or 
li ne of s yste mic a ntica ncer t hera p y i n a l ocall y a d va nce d/ metastatic setti n g is re q uire d a n d 
n ot m ore t ha n 2 pri or li nes of s yste mic a ntica ncer t hera p y i n a l ocall y a d va nce d/ metastatic 
setti n g are all o we d. Patie nts treate d wit h a ta xa ne wit hi n 1 2 m o nt hs or patie nts refract or y t o 
pri or ta xa ne treat me nt are e xcl u de d.
N ote: Mai nte na nce t hera pies are n ot c o u nte d as se parate li nes of t hera p y.
4. 3.  
E xcl usi o n Criteri a
Patie nts w h o meet a ny  of t he f oll o wi n g e xcl usi o n criteria are n ot t o be e nr olle d i n t his st u d y:
1)
P ositi ve ser u m pre g na nc y test
2)
Breastfee di n g fe male
3)
Acti ve C N S disease. Patie nts wit h as y m pt o matic a n d sta ble, treate d C N S lesi o ns (ra diati o n 
a n d/ or s ur ger y a n d/ or ot her C N S- directe d t hera p y w h o are off c ortic oster oi ds f or at least 
4 wee ks) are all o we d.
4)
Re d bl o o d cell tra nsf usi o n de pe n de nce, defi ne d as re q uiri n g m ore t ha n 2 u nits of pac ke d 
R B C tra nsf usi o ns d uri n g t he 4- wee k peri o d pri or t o scree ni n g. Re d bl o o d cell tra nsf usi o ns 
are per mitte d d uri n g t he scree ni n g peri o d a n d pri or t o e nr oll me nt t o meet t he he m o gl o bi n 
i ncl usi o n criteria.
5)
Hist or y of he m ol ytic a ne mia, a ut oi m m u ne t hr o m b oc yt o pe nia or E va ns s y n dr o me i n t he last 
3 m o nt hs
6)
K n o w n h y perse nsiti vit y t o a n y of t he st u d y dr u gs, t he meta b olites, or f or m ulati o n e xci pie nt
7)
Pri or treat me nt wit h C D 4 7- or SI R P α-tar geti n g a ge nts
8)
C urre nt partici pati o n i n a n ot her i nter ve nti o nal cli nical st u d y 
9)
K n o w n i n herite d or ac q uire d blee di n g dis or ders
1 0) Si g nifica nt disease or me dical c o n diti o ns, as assesse d b y t he i n vesti gat or a n d s p o ns or, t hat 
w o ul d s u bsta ntiall y i ncrease t he ris k- be nefit rati o of partici pati n g i n t he st u d y. T his i ncl u des, 
b ut is n ot li mite d t o, ac ute m y ocar dial i nfarcti o n wit hi n t he last 6 m o nt hs, u nsta ble a n gi na, 
u nc o ntr olle d dia betes mellit us, si g nifica nt acti ve i nfecti o ns, a n d c o n gesti ve heart fail ure 
Ne w Y or k Heart Ass ociati o n Class III-I V.
1 1) Sec o n d mali g na nc y, e xce pt treate d basal cell or l ocalize d s q ua m o us s ki n carci n o mas, 
l ocalize d pr ostate ca ncer, or ot her mali g na ncies f or w hic h patie nts are n ot o n acti ve 
a ntica ncer t hera pies a n d w h o are i n c o m plete re missi o n f or o ver 3 years

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 4 6
2 4 Oct o ber 2 0 2 3
1 2) K n o w n acti ve or c hr o nic he patitis B or C i nfecti o n or h u ma n i m m u n o deficie nc y vir us 
i nfecti o n i n me dical hist or y
1 3) Pri or a ntica ncer t hera p y i ncl u di n g b ut n ot li mite d t o c he m ot hera p y, i m m u n ot hera p y, or 
i n vesti gati o nal a ge nts wit hi n 4 wee ks pri or t o ma gr oli ma b is n ot per mitte d.
N O T E: Palliati ve, l ocalize d, n o n- C N S ra di ot hera p y t o areas of n o ntar get disease, pre vi o us 
h or m o nal t hera p y wit h l utei nizi n g h or m o ne releasi n g h or m o ne ( L H R H) a g o nists f or pr ostate 
or breast ca ncer, a n d treat me nt wit h bis p h os p h o nates a n d rece pt or acti vat or of n uclear fact or 
ka p pa B li ga n d ( R A N K L) i n hi bit ors are n ot criteria f or e xcl usi o n. T here is n o re q uire d 
mi ni m u m was h o ut peri o d f or t hese t hera pies. Patie nts s h o ul d be rec o vere d fr o m t he effects of 
ra diati o n.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 4 7
2 4 Oct o ber 2 0 2 3
5.  
I N V E S TI G A TI O N A L M E DI CI N A L P R O D U C T S
5. 1.   
R a n d o miz ati o n, Bli n di n g, a n d Tre at me nt C o des Access
5. 1. 1.   
R a n d o miz ati o n
Ra n d o mizati o n will n ot be perf or me d i n t his st u d y.
5. 1. 2.  
Bli n di n g
Bli n di n g of treat me nt assi g n me nts or data will n ot be perf or me d i n t his st u d y.
5. 2.   
Descri pti o n a n d H a n dli n g of M a gr oli m a b
5. 2. 1.  
F or m ul ati o n
Ma gr oli ma b is f or m ulate d as a sterile, clear, preser vati ve-free li q ui d i nte n de d f or I V 
a d mi nistrati o n c o ntai ni n g 1 0 m M s o di u m acetate, 5 % ( wei g ht-t o- v ol u me rati o [ w/ v]) s or bit ol, 
0. 0 1 % ( w/ v) p ol ys or bate 2 0 at p H of 5. 0. Eac h vial is ma n ufact ure d t o e ns ure a deli vera ble 
v ol u me of 1 0 m L c o ntai ni n g 2 0 0 m g of ma gr oli ma b at a c o nce ntrati o n of 2 0 m g/ m L.
5. 2. 2.  
P ac k a gi n g a n d L a beli n g
Ma gr oli ma b is s u p plie d i n si n gle- use, 1 0- m L glass vials wit h c oate d elast o meric st o p pers a n d 
al u mi n u m cri m p o verseals wit h a fli p- off ca p.
St u d y dr u g(s) t o be distri b ute d t o ce nters i n t he U S a n d ot her partici pati n g c o u ntries s hall be 
la bele d t o meet a p plica ble re q uire me nts of t he U S F D A, E ur o pea n U ni o n ( E U) G ui deli ne t o 
G o o d Ma n ufact uri n g Practice - A n ne x 1 3 (I n vesti gati o nal Me dici nal Pr o d ucts), a n d/ or ot her 
l ocal re g ulati o ns.
5. 2. 3.  
St or a ge a n d H a n dli n g
Ma gr oli ma b s h o ul d be st ore d at 2 ° C t o 8 ° C ( 3 6 ° F t o 4 6 ° F). Ma gr oli ma b s h o ul d n ot be fr oze n. 
Pr otect fr o m li g ht d uri n g st ora ge. D o n ot s ha ke. St ora ge c o n diti o ns are s pecifie d o n t he la bel. 
U ntil dis pe nse d t o t he patie nts, st u d y dr u gs s h o ul d be st ore d i n a sec urel y l oc ke d area, accessi ble 
o nl y t o a ut h orize d site pers o n nel.
T o e ns ure t he sta bilit y a n d pr o per i de ntificati o n, st u d y dr u g(s) s h o ul d n ot be st ore d i n a c o ntai ner 
ot her t ha n t he c o ntai ner i n w hic h t he y were s u p plie d.
C o nsi derati o n s h o ul d be gi ve n t o ha n dli n g, pre parati o n, a n d dis p osal t hr o u g h meas ures t hat 
mi ni mize dr u g c o ntact wit h t he b o d y. A p pr o priate preca uti o ns s h o ul d be f oll o we d t o a v oi d direct 
e ye c o ntact or e x p os ure w he n ha n dli n g.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 4 8
2 4 Oct o ber 2 0 2 3
5. 3.   
Descri pti o n a n d H a n dli n g of D ocet a xel
5. 3. 1.  
F or m ul ati o n
D oceta xel is c o m merciall y s o urce d. I nf or mati o n re gar di n g t he f or m ulati o n ca n be f o u n d i n t he 
c urre nt prescri bi n g i nf or mati o n.
5. 3. 2.  
P ac k a gi n g a n d L a beli n g
C o m mercial pr o d uct of d oceta xel will be use d f or t his st u d y. St u d y dr u g(s) t o be distri b ute d t o 
ce nters i n t he U S a n d ot her partici pati n g c o u ntries s hall be la bele d t o meet a p plica ble 
re q uire me nts of t he U S F D A, E U G ui deli ne t o G o o d Ma n ufact uri n g Practice – A n ne x 1 3 
(I n vesti gati o nal Me dici nal Pr o d ucts), a n d/ or ot her l ocal re g ulati o ns. Alter nati vel y, i n ali g n me nt 
wit h l ocal re g ulati o ns, c o m mercial pr o d uct ma y be s o urce d l ocall y b y t he sites.
5. 3. 3.  
St or a ge a n d H a n dli n g
D oceta xel is c o m merciall y s o urce d. I nf or mati o n re gar di n g t he st ora ge a n d ha n dli n g ca n be f o u n d 
i n t he c urre nt prescri bi n g i nf or mati o n.
5. 4.   
D os a ge a n d A d mi nistr ati o n of M a gr oli m a b
Vital si g ns will be assesse d pri or t o a n y I V st u d y dr u g a d mi nistrati o n.
Ma gr oli ma b s h o ul d be a d mi nistere d as o utli ne d i n t he P har mac y Ma n ual f or t he st u d y. T he d ose 
of ma gr oli ma b will be calc ulate d base d o n act ual wei g ht e nr oll me nt ( usi n g wei g ht o btai ne d 
eit her at scree ni n g or o n Da y 1) a n d will re mai n c o nsta nt t hr o u g h o ut t he st u d y, u nless t here is a 
> 1 0 % c ha n ge i n wei g ht fr o m baseli ne. M o dificati o ns t o t he st u d y dr u g d oses a d mi nistere d 
s h o ul d be ma de f or a > 1 0 % c ha n ge i n b o d y wei g ht a n d/ or acc or di n g t o l ocal a n d re gi o nal 
prescri bi n g sta n dar ds. D ose m o dificati o ns f or c ha n ges i n b o d y wei g ht < 1 0 % ma y be ma de 
acc or di n g t o l ocal i nstit uti o nal g ui deli nes.
T he d urati o n f or t he first ma gr oli ma b ( pri mi n g) i nf usi o n will be 3 h o urs ( ± 3 0 mi n utes). F or 
s u bse q ue nt d oses, t he ma gr oli ma b ( mai nte na nce) i nf usi o n will be 2 h o urs ( ± 3 0 mi n utes). T he 
re d uce d i nf usi o n ti me t o 2 h o urs is utilize d base d o n pri or data de m o nstrati n g maj orit y C D 4 7 R O 
o n peri p heral bl o o d cells, t h us miti gati n g a ntici pate d R B C t o xicities fr o m ma gr oli ma b. All 
patie nts s h o ul d be m o nit ore d h o url y d uri n g i nf usi o n. Patie nts s h o ul d be m o nit ore d (i ncl u di n g 
meas ure me nt of vital si g ns, as cli nicall y a p pr o priate) f or si g ns a n d s y m pt o ms of I R Rs, w hic h 
ha ve bee n o bser ve d i n pre vi o us ma gr oli ma b st u dies.
Ma gr oli ma b d oses will be gi ve n wee kl y d uri n g C ycles 1 a n d 2. Ma gr oli ma b is t he n a d mi nistere d 
e ver y 3 wee ks d uri n g C ycle 3 a n d be y o n d f or a 2 1- da y c ycle. M a gr oli m a b d oses are n ot t o be 
gi ve n o n c o nsec uti ve d a ys .
W he n ma gr oli ma b is gi ve n i n c o m bi nati o n wit h d oceta xel ( Safet y R u n-i n C o h ort 1 a n d P hase 2 
C o h ort 1), ma gr oli ma b will be i nf use d first. All patie nts will be m o nit ore d f or 1 h o ur 
p osti nf usi o n f or pri mi n g, re pri mi n g, a n d mai nte na nce d oses d uri n g C ycle 1. P osti nf usi o n 
m o nit ori n g s h o ul d be gi n after t he i nf usi o n is c o m plete b ut pri or t o a d mi nisteri n g d oceta xel. 

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 4 9
2 4 Oct o ber 2 0 2 3
P osti nf usi o n m o nit ori n g is n ot re q uire d f or d oses after C ycle 1. Patie nts w h o e x perie nce a n y 
treat me nt-e mer ge nt A Es d uri n g t he o bser vati o n peri o d s h o ul d be f urt her m o nit ore d, as cli nicall y 
a p pr o priate. Refer t o Secti o n 7. 8. 1. 1. 2  f or p osti nf usi o n he m o gl o bi n re p orti n g re q uire me nts.
Patie nts ma y c o nti n ue st u d y treat me nt u ntil t he y s h o w e vi de nce of disease pr o gressi o n, rela pse, 
l oss of cli nical be nefit, or u nacce pta ble t o xicit y (f urt her details a b o ut treat me nt disc o nti n uati o n 
are i n Secti o n 3. 4 ).
Tre at me nt Del a y a n d Re pri mi n g f or M a gr oli m a b
Gi ve n t he lar ge C D 4 7 a nti ge n si n k o n n or mal cells, patie nts w h o ha ve a l o n g d ose dela y of 
ma gr oli ma b are re q uire d t o be re pri me d wit h ma gr oli ma b d osi n g t o resat urate t he C D 4 7 a nti ge n 
si n k. G ui deli nes f or re pri mi n g/re-escalati o n f or ma gr oli ma b after a d ose dela y is pr o vi de d i n 
Secti o n 5. 5 .
T he ma gr oli ma b d osi n g re gi me ns f or eac h c o h ort are descri be d i n Ta ble 2  a n d Ta ble 3 .
5. 5.   
D ose M o dific ati o ns a n d Del a ys f or M a gr oli m a b
T he d ose of ma gr oli ma b s h o ul d n ot be re d uce d e xce pt i n Safet y R u n-i n C o h ort 1 i n t he case of 
d ose de-escalati o n base d o n D L Ts. 
Cli nical safet y a n d P K data fr o m d ose-fi n di n g st u dies i n b ot h s oli d t u m or a n d he mat ol o gic 
mali g na ncies ha ve n ot de m o nstrate d a n y d ose- de pe n de nt t o xicities ass ociate d wit h ma gr oli ma b. 
D ose re d ucti o n/ m o dificati o n ma y be all o we d i n certai n A Es/circ u msta nces t hat m ust be 
a p pr o ve d b y t he s p o ns or. If a d ose re d ucti o n is c o nsi dere d, a n i nitial a p pr o xi matel y 3 3 % d ose 
re d ucti o n fr o m t he rec o m me n de d P hase 2 d ose s h o ul d be d o ne (e g, fr o m 3 0 m g/ k g t o 2 0 m g/ k g 
a n d fr o m 2 0 m g/ k g t o 1 5 m g/ k g).
W he n d oceta xel is dela ye d d ue t o t o xicities, ma gr oli ma b s h o ul d c o nti n ue i n de pe n de ntl y as per 
t he ma gr oli ma b a d mi nistrati o n sc he d ule. C o nti n u o us d osi n g of ma gr oli ma b is nee de d t o 
mai ntai n efficaci o us e x p os ures a n d o pti mal efficac y. D uri n g t he mai nte na nce p hase 
( C ycle 3 o n war ds), if t he last d ose of ma gr oli ma b was a d mi nistere d wit hi n t he pre vi o us 1 0 t o 
2 0 da ys, t he s u bse q ue nt ma gr oli ma b d ose ma y be a d mi nistere d earlier t ha n sc he d ule d i n or der t o 
s y nc hr o nize wit h t he bac k b o ne c he m ot hera p y a d mi nistrati o n. 
Ma gr oli ma b ma y be wit h hel d if treat me nt-e mer ge nt a n d/ or relate d A Es occ ur, a n d will re q uire 
c o ns ultati o n wit h t he s p o ns or if t he dela y is l o n ger t ha n 3 da ys. I n t he e ve nt of ma gr oli ma b 
dela y, d osi n g s h o ul d res u me as s o o n as it is cli nicall y a p pr o priate a n d l o gisticall y p ossi ble, 
wit h o ut waiti n g t o ali g n wit h t he patie nt’s ori gi nal e ver y- 3- wee ks sc he d ule. 
T he re pri mi n g g ui deli nes s h o w n i n Ta ble 4  s h o ul d be f oll o we d f or patie nts wit h ma gr oli ma b 
d ose dela ys. D uri n g re pri mi n g, c ycle n u m beri n g a n d efficac y, bi o mar ker, P K, a n d 
i m m u n o ge nicit y assess me nts s h o ul d c o nti n ue as per assi g ne d c ycle n u m ber. T he safet y 
assess me nt s h o ul d f oll o w t he C ycle 1 safet y assess me nts a n d s witc h bac k t o assi g ne d c ycle 
sc he d ule s u bse q ue ntl y. If re pri mi n g is necessar y bef ore t he patie nt c o m pletes C ycle 1 or C ycle 2, 
t he re pri mi n g c ycle is a d mi nistere d b y re peati n g C ycle 1 d osi n g, f oll o we d b y C ycle 2 bef ore 
pr ocee di n g t o us ual sc he d uli n g.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 5 0
2 4 Oct o ber 2 0 2 3
Criteria f or per ma ne nt disc o nti n uati o n of ma gr oli ma b i ncl u de t he f oll o wi n g:
•
Gra de 4 I R R, as descri be d i n Secti o n 7. 8. 1
•
Gra de 4 n o n he mat ol o gic A E relate d t o ma gr oli ma b t hat d oes n ot i m pr o ve t o Gra de 2 or 
baseli ne wit hi n 3 0 da ys
If ma gr oli ma b is disc o nti n ue d f or reas o ns ot her t ha n disease pr o gressi o n, t he re mai ni n g dr u g(s) 
i n t he c o m bi nati o n re gi me n ma y be c o nti n ue d. Ma gr oli ma b ma y be wit h hel d if 
treat me nt-e mer ge nt a n d/ or ma gr oli ma b-relate d A Es occ ur, u ntil cli nical res ol uti o n or 
i m pr o ve me nt per t he treati n g p h ysicia n.
Treat me nt dela ys ( n ot d ue t o A Es) of m ore t ha n 4 wee ks (s uc h as a n u nrelate d me dical c o n diti o n 
wit h e x pecte d rec o ver y) m ust be a p pr o ve d b y t he s p o ns or.
T a ble 4.
Re pri mi n g G ui deli nes f or M a gr oli m a b
D ose
D osi n g fre q ue nc y
Mi ni m u m d ur ati o n of tre at me nt 
g a p t h at will le a d t o re pri mi n g
1 m g/ k g
N A – use d at i nitial pri mi n g
2 wee ks
1 5 m g/ k g
Wee kl y ( d uri n g C ycles 1 a n d/ or 2)
2 wee ks
Wee kl y ( d uri n g C ycles 1 a n d/ or 2)
2 wee ks
2 0 m g/ k g
E ver y 3 wee ks
4 wee ks
Wee kl y ( d uri n g C ycles 1 a n d/ or 2)
4 wee ks
3 0 m g/ k g
E ver y 3 wee ks
4 wee ks
4 5 m g/ k g
E ver y 3 wee ks
4 wee ks
6 0 m g/ k g
E ver y 3 wee ks
4 wee ks
N A = n ot a p plica ble
If pla n ne d s ur gical pr oce d ures are nee de d f or patie nts o n st u d y treat me nt, ma gr oli ma b will be 
dela ye d a n d restarte d i n acc or da nce wit h Ta ble 5 .

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 5 1
2 4 Oct o ber 2 0 2 3
T a ble 5.
M a gr oli m a b D osi n g G ui d a nce f or Pl a n ne d S ur gic al Pr oce d ures o n 
St u d y
Pl a n ne d S ur gic al Pr oce d ure
M a gr oli m a b D ose G ui d a nce
Mi ni mall y i n vasi ve pr oce d ure
( E xa m ples: bi o psies [e xcl u di n g l u n g/li ver], s ki n/s u bc uta ne o us 
lesi o n re m o val, cataract/ gla uc o ma/e ye s ur ger y/c yst osc o p y)
H ol d ma gr oli ma b d ose 3 da ys pri or t o pr oce d ure a n d 
restart after 3 da ys
M o deratel y i n vasi ve pr oce d ure
( E xa m ples: l u n g/li ver bi o ps y, h ysterect o m y, c h olec ystect o m y, 
hi p/ k nee re place me nt, mi n or la par osc o pic pr oce d ures, 
ste nt/a n gi o pat h y)
H ol d ma gr oli ma b d ose 3 da ys pri or t o pr oce d ure a n d 
restart after 5 da ys
Hi g hl y i n vasi ve pr oce d ure
( E xa m ples: ce ntral ner v o us s yste m/s pi ne s ur ger y, maj or vasc ular 
s ur ger y, car di ot h oracic s ur ger y, maj or la par osc o pic s ur ger y)
H ol d ma gr oli ma b d ose 3 da ys pri or t o pr oce d ure a n d 
restart after 7 da ys
5. 6.   
M a gr oli m a b Pre me dic ati o n a n d Pr o p h yl a xis
Pre me dicati o n is re q uire d pri or t o t he a d mi nistrati o n of t he first 2 d oses of ma gr oli ma b a n d i n 
case of rei ntr o d ucti o n wit h re pri mi n g. Pre me dicati o n d uri n g s u bse q ue nt i nf usi o ns ma y be 
c o nti n ue d base d o n t he treati n g p h ysicia n’s cli nical j u d g me nt a n d t he prese nce/se verit y of pri or 
I R Rs. G ui da nce is pr o vi de d i n Secti o n 7. 8. 1. 2 .
Pre me dicati o ns s h o ul d i ncl u de oral aceta mi n o p he n 6 5 0 t o 1 0 0 0 m g, oral or I V di p he n h y dra mi ne 
2 5 t o 5 0 m g, a n d I V de xa met has o ne 4 t o 2 0 m g, or c o m para ble re gi me n. If less t ha n 4 h o urs has 
ela pse d si nce a pri or d ose of aceta mi n o p he n has bee n gi ve n, t he d ose of aceta mi n o p he n 
pre me dicati o n ma y be o mitte d.
5. 7.  
Pri or a n d C o nc o mit a nt Me dic ati o ns
5. 7. 1.  
Pri or a n d C o nc o mit a nt Me dic ati o ns Wit h M a gr oli m a b
5. 7. 1. 1.  
Per mitte d C o nc o mita nt Me dicati o ns
Pre me dicati o n a n d pr o p h yla xis f or A Es is per mitte d w hile o n st u d y treat me nt. Palliati ve, 
l ocalize d n o n- C N S ra di ot hera p y t o areas of n o ntar get disease, er yt hr oi d a n d/ or m yel oi d gr o wt h 
fact ors, h or m o nal t hera p y, L H R H a g o nists f or pr ostate ca ncer, h or m o nal mai nte na nce t hera p y 
f or breast ca ncers, a n d treat me nt wit h bis p h os p h o nates/ R A N K L i n hi bit ors are per mitte d. 
C ortic oster oi d use is per mitte d f or s y m pt o matic treat me nt, pre me dicati o n, pse u d o pr o gressi o n, 
a n d/ or s pecific patie nt c o n diti o ns. C hr o nic hi g h- d ose ster oi d use is n ot rec o m me n de d u nless 
cli nicall y i n dicate d. Re d bl o o d cell a n d platelet tra nsf usi o n are per mitte d d uri n g t he st u d y as 
cli nicall y i n dicate d a n d rec or de d i n t he electr o nic case re p ort f or m (e C R F) de dicate d t o o n-st u d y 
tra nsf usi o ns. All c o nc o mita nt me dicati o ns, i ncl u di n g all prescri pti o n, o ver-t he-c o u nter, her bal 
s u p ple me nts, a n d I V me dicati o ns a n d fl ui ds recei ve d wit hi n 3 0 da ys bef ore t he first d ose of 
st u d y treat me nt t hr o u g h t he 3 0- da y safet y f oll o w- u p visit are t o be rec or de d i n t he e C R F. O nl y 
t he dr u g na me, i n dicati o n, r o ute, a n d dates of c o nc o mita nt me dicati o ns will be ca pt ure d i n t he 
e C R F.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 5 2
2 4 Oct o ber 2 0 2 3
T here are n o s u bsta ntial safet y data re gar di n g t he c o nc o mita nt a d mi nistrati o n of t he C O VI D ‑1 9 
vacci nes a n d ma gr oli ma b. Patie nts are all o we d t o recei ve t he C O VI D ‑1 9 vacci ne, a n d st u d y 
visits s h o ul d c o nti n ue as pla n ne d if vacci nati o n occ urs w hile t he patie nt is o n t he st u d y. 
I n vesti gat ors s h o ul d f oll o w l ocal g ui deli nes f or c o nc o mita nt a d mi nistrati o n of t he C O VI D- 1 9 
vacci nes wit h t he st u d y dr u gs.
5. 7. 1. 2.  
Pr o hi bite d C o nc o mita nt Me dicati o ns
A ntica ncer t hera pies i ncl u di n g c he m ot hera p y, tar gete d t hera pies, a n d i m m u n ot hera p y (a part 
fr o m st u d y dr u gs) are n ot per mitte d w hile patie nts are o n st u d y.
5. 7. 2.  
Pri or a n d C o nc o mit a nt Me dic ati o ns Wit h D ocet a xel
T he c urre nt prescri bi n g i nf or mati o n s h o ul d be f oll o we d f or per mitte d a n d pr o hi bite d 
c o nc o mita nt me dicati o ns.
5. 8.   
D os a ge a n d A d mi nistr ati o n of D ocet a xel
T he d oceta xel d osi n g re gi me ns f or Safet y R u n-i n C o h ort 1 a n d P hase 2 C o h ort 1 are descri be d i n 
Ta ble 2  a n d Ta ble 3 , res pecti vel y.
5. 9.   
D ocet a xel Pre me dic ati o n a n d Pr o p h yl a xis
F or d oceta xel treat me nt, all patie nts s h o ul d be pre me dicate d t o re d uce t he i nci de nce a n d se verit y 
of h y perse nsiti vit y reacti o ns a n d fl ui d rete nti o n per t heir i nstit uti o nal sta n dar d of care or as 
f oll o ws. S uc h pre me dicati o n ma y c o nsist of oral c ortic oster oi ds s uc h as de xa met has o ne 1 6 m g 
per da y (e g, 8 m g t wice dail y) f or 3 da ys starti n g 1 da y pri or t o d oceta xel. F or i nsta nces w he n a 
patie nt d oes n ot start oral c ortic oster oi ds pri or t o d oceta xel a d mi nistrati o n, I V de xa met has o ne 
per i nstit uti o nal sta n dar d of care ca n be gi ve n pri or t o d oceta xel a d mi nistrati o n.
5. 1 0.   
D ose M o dific ati o ns f or D ocet a xel
D oceta xel is k n o w n t o ca use ne utr o pe nia, he pat ot o xicit y, peri p heral ne ur o pat h y, fl ui d rete nti o n, 
a n d h y perse nsiti vit y reacti o ns. D ose re d ucti o ns per ke y t o xicities are descri be d bel o w as 
rec o m me n dati o ns a n d are i n acc or da nce wit h t he d oceta xel prescri bi n g i nf or mati o n. A d diti o nal 
t o xicit y ma na ge me nt g ui deli nes are pr o vi de d i n d oceta xel prescri bi n g i nf or mati o n.
5. 1 0. 1.   
Ne utr o pe ni a
D oceta xel ca uses ne utr o pe nia; g ui da nce o n d ose re d ucti o ns are s h o w n i n Ta ble 6 . Patie nts s h o ul d 
ha ve a n A N C of at least 1 5 0 0 cells/ µ L bef ore i nitiati n g t he ne xt c ycle of d oceta xel t hera p y. 
M yel oi d gr o wt h fact or s u p p ort is all o we d per i nstit uti o nal g ui deli nes.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 5 3
2 4 Oct o ber 2 0 2 3
T a ble 6.
D ocet a xel D ose M o dific ati o ns f or Ne utr o pe ni a
He m at ol o gic T o xicit y
Occ urre nce
D ocet a xel D ose per 
C ycle ( m g/ m 2)a
First
5 5
Sec o n d
3 7. 5
Ne utr o pe nic fe ver ( na dir A N C < 5 0 0 cells/ µ L wit h fe ver > 3 8 ° C) 
f or > 7 da ys des pite gr o wt h fact or s u p p ort
Dela y of ne xt c ycle b y > 1 4 da ys f or na dir A N C < 1 5 0 0 cells/ µ L
or
Na dir A N C < 5 0 0 cells/ µl f or > 7 da ys
T hir d 
Disc o nti n ue treat me nt
A N C = a bs ol ute ne utr o p hil c o u nt
a  
If d oceta xel is d ose de-escalate d i n Safet y R u n-i n C o h ort 1 a n d t his d ose is utilize d i n P hase 2, t he n d ose re d ucti o ns s h o ul d 
f oll o w t he ne xt l o west d ose. F or e xa m ple, if a 5 5 m g/ m2 d oceta xel d ose is selecte d wit h ma gr oli ma b (as part of d ose 
de-escalati o n), t he n i n t he first i nsta nce of t o xicit y, d oceta xel s h o ul d be d ose re d uce d t o 3 7. 5 m g/ m 2. If a 3 7. 5 m g/ m2 
d oceta xel d ose is selecte d wit h ma gr oli ma b (as part of d ose de-escalati o n), t he n i n t he first i nsta nce of t o xicit y, d oceta xel 
w o ul d be disc o nti n ue d.
5. 1 0. 2.   
He p atic T o xicit y
D oceta xel s h o ul d be wit h hel d f or Gra de 3 or 4 he patic t o xicit y dee me d relate d t o d oceta xel as 
s pecifie d i n Ta ble 7 . Gi ve n t hat ma gr oli ma b ca n ca use tra nsie nt i ncrease i n i n direct bilir u bi n d ue 
t o o n-tar get a ne mia, d ose m o dificati o ns f or d oceta xel i n t he case of bilir u bi n m ust n ot be 
attri b ute d t o ma gr oli ma b. I n a d diti o n, t he i n vesti gat or s h o ul d ma ke all eff orts t o e xcl u de 
mali g na nt disease pr o gressi o n as a ca use of li ver e nz y me dera n ge me nt, w hic h w o ul d n ot be 
c o nsi dere d a t o xicit y f or d oceta xel.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 5 4
2 4 Oct o ber 2 0 2 3
T a ble 7.
D ocet a xel D ose Re d ucti o ns f or He p atic T o xicit y
He p atic T o xicit y
Occ urre nce 
D ocet a xel D ose M o dific ati o n a
First 
I nterr u pt treat me nt u ntil A S T/ A L T le vel is 
≤ 1. 5  U L N a n d  al kali ne p h os p hatase le vel is 
≤ 2. 5  U L N, t he n re d uce t o 5 5 m g/ m2.
I nterr u pt treat me nt u ntil bilir u bi n ≤ 1. 2 5  U L N, t he n 
re d uce t o 5 5 m g/ m2.
If t o xicit y d oes n ot res ol ve t o a b o ve criteria wit hi n 
3 wee ks, disc o nti n ue treat me nt.
Sec o n d 
I nterr u pt treat me nt u ntil A S T/ A L T le vel is 
< 1. 5  U L N a n d  al kali ne p h os p hatase le vel is 
≤ 2. 5  U L N, t he n re d uce t o 3 7. 5 m g/ m2.
I nterr u pt treat me nt u ntil bilir u bi n ≤ 1. 2 5  U L N, t he n 
re d uce t o 3 7. 5 m g/ m2.
If t o xicit y d oes n ot res ol ve t o a b o ve criteria wit hi n 
3 wee ks, disc o nti n ue treat me nt.
A S T or A L T le vel > 1. 5  U L N ( or 
baseli ne if hi g her) a n d al kali ne 
p h os p hatase > 2. 5  U L N
or
Bilir u bi n le vel > 1. 2 5  U L N ( n ot 
attri b ute d t o ma gr oli ma b a n d is m ostl y 
direct)
T hir d 
Disc o nti n ue treat me nt
A S T or A L T > 3  U L N ( or baseli ne if 
hi g her) a n d  bilir u bi n > 2  U L N ( n ot 
attri b ute d t o ma gr oli ma b a n d is m ostl y 
direct)
A n y 
Disc o nti n ue treat me nt
Bilir u bi n > 5  U L N ( n ot attri b ute d t o 
ma gr oli ma b a n d is m ostl y direct)
A n y 
Disc o nti n ue treat me nt
A S T or A L T > 5 t o 1 0  U L N f or 
> 2 wee ks
or
A S T or A L T > 1 0  U L N or baseli ne
A n y 
Disc o nti n ue treat me nt
A L T = ala ni ne a mi n otra nsferase; A S T = as partate a mi n otra nsferase; U L N = u p per li mit of n or mal
a  
If d oceta xel is d ose de-escalate d i n Safet y R u n-i n C o h ort 1 a n d t his d ose is utilize d i n P hase 2, t he n d ose re d ucti o ns s h o ul d 
f oll o w t he ne xt l o west d ose. F or e xa m ple, if a 5 5 m g/ m2 d oceta xel d ose is selecte d wit h ma gr oli ma b (as part of d ose 
de-escalati o n), t he n i n t he first i nsta nce of t o xicit y, d oceta xel s h o ul d be d ose re d uce d t o 3 7. 5 m g/ m 2. If a 3 7. 5 m g/ m² 
d oceta xel d ose is selecte d wit h ma gr oli ma b (as part of d ose de-escalati o n), t he n i n t he first i nsta nce of t o xicit y, d oceta xel 
w o ul d be disc o nti n ue d.
5. 1 0. 3.  
Peri p her al Ne ur o p at h y
Patie nts w h o de vel o p ≥ Gra de 3 peri p heral ne ur o pat h y relate d t o d oceta xel s h o ul d ha ve 
d oceta xel disc o nti n ue d per ma ne ntl y.
5. 1 0. 4.   
Ot her T o xicities
Ta ble 8  s h o ws t he d oceta xel d ose m o dificati o ns f or ot her Gra de 3 or 4 he mat ol o gic or 
n o n he mat ol o gic t o xicities dee me d relate d t o d oceta xel. D oceta xel s h o ul d be dela ye d u ntil 
i m pr o ve me nt of Gra de 3 or 4 t o xicit y t o at least Gra de 2 or better or baseli ne.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 5 5
2 4 Oct o ber 2 0 2 3
T a ble 8.
D ocet a xel D ose M o dific ati o ns f or Ot her Gr a de 3/ 4 T o xicities 
Ot her T o xicit y
Occ urre nce
D ocet a xel D ose per C ycle 
( m g/ m2)a
First
5 5
Sec o n d
3 7. 5
Gra de 3 or 4 n o n he mat ol o gic or 
he mat ol o gic t o xicit y b t hat d oes n ot 
res ol ve t o ≤ Gra de 2 wit hi n 1 4 da ys 
T hir d
Disc o nti n ue treat me nt
a  
If d oceta xel is d ose de-escalate d i n Safet y R u n-i n C o h ort 1 a n d t his d ose is utilize d i n P hase 2, t he n d ose re d ucti o ns s h o ul d 
f oll o w t he ne xt l o west d ose. F or e xa m ple, if a 5 5 m g/ m2 d oceta xel d ose is selecte d wit h ma gr oli ma b (as part of d ose 
de-escalati o n), t he n i n t he first i nsta nce of t o xicit y, d oceta xel s h o ul d be d ose re d uce d t o 3 7. 5 m g/ m 2. If a 3 7. 5 m g/ m² 
d oceta xel d ose is selecte d wit h ma gr oli ma b (as part of d ose de-escalati o n), t he n i n t he first i nsta nce of t o xicit y, d oceta xel 
w o ul d be disc o nti n ue d.
b   
Gra de 3 or 4 n o n he mat ol o gic or he mat ol o gic t o xicities a p pl y t o t h ose n ot descri be d i n t he a b o ve d ose m o dificati o n secti o ns.
5. 1 1.   
Acc o u nt a bilit y f or I n vesti g ati o n al Me dici n al Pr o d uct
T he i n vesti gat or is res p o nsi ble f or e ns uri n g a de q uate acc o u nta bilit y of all use d a n d u n use d st u d y 
dr u g ( kits, vials, etc). T his i ncl u des ac k n o wle d g me nt of recei pt of eac h s hi p me nt of st u d y dr u g 
( q ua ntit y a n d c o n diti o n).
Eac h st u d y site m ust kee p acc o u nta bilit y rec or ds t hat ca pt ure:
•
T he date recei ve d a n d q ua ntit y of st u d y dr u g ( kits, vials, etc)
•
T he date, patie nt n u m ber, a n d t he st u d y l ot n u m ber dis pe nse d
•
T he date, q ua ntit y of use d a n d u n use d st u d y dr u g ret ur ne d, al o n g wit h t he i nitials of t he 
pers o n rec or di n g t he i nf or mati o n
5. 1 1. 1.  
I n vesti g ati o n al Me dici n al Pr o d uct Ret ur n or Dis p os al
Gilea d rec o m me n ds t hat use d a n d u n use d st u d y dr u g s u p plies be destr o ye d at t he site. If t he site 
has a n a p pr o priate sta n dar d o perati n g pr oce d ure ( S O P) f or dr u g destr ucti o n as deter mi ne d b y 
Gilea d, t he site ma y destr o y use d (e m pt y or partiall y e m pt y) a n d u n use d st u d y dr u g s u p plies i n 
acc or da nce wit h t hat site’s a p pr o ve d S O P. A c o p y of t he site’s a p pr o ve d S O P will be o btai ne d 
f or t he electr o nic trial master file. If st u d y dr u g is destr o ye d at t he site, t he i n vesti gat or m ust 
mai ntai n acc urate rec or ds f or all st u d y dr u gs destr o ye d. Rec or ds m ust s h o w t he i de ntificati o n 
a n d q ua ntit y of eac h u nit destr o ye d, t he met h o d of destr ucti o n, a n d t he pers o n w h o dis p ose d of 
t he st u d y dr u g. U p o n st u d y c o m pleti o n, c o pies of t he st u d y dr u g acc o u nta bilit y rec or ds m ust be 
file d at t he site. A n ot her c o p y will be ret ur ne d t o Gilea d.
If t he site d oes n ot ha ve a n a p pr o priate S O P f or st u d y dr u g destr ucti o n, use d a n d u n use d st u d y 
dr u g s u p plies are t o be se nt t o t he desi g nate d dis p osal facilit y f or destr ucti o n. T he st u d y m o nit or 
will pr o vi de i nstr ucti o ns f or ret ur n.
T he st u d y m o nit or will re vie w st u d y dr u g s u p plies a n d ass ociate d rec or ds at peri o dic i nter vals.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 5 6
2 4 Oct o ber 2 0 2 3
6.  
S T U D Y P R O C E D U R E S
T he st u d y pr oce d ures t o be c o n d ucte d f or eac h patie nt e nr olle d i n t he st u d y are prese nte d i n 
ta b ular f or m i n A p pe n di x Ta ble 1  a n d A p pe n di x Ta ble 2 , a n d descri be d i n t he f oll o wi n g 
secti o ns.
T he i n ve sti gat or m ust d oc u me nt a n y de viati o n fr o m t he pr ot oc ol pr oce d ures a n d n otif y Gilea d or 
t he c o ntract researc h or ga nizati o n ( C R O).
6. 1.  
P atie nt E nr oll me nt a n d Tre at me nt Assi g n me nt
E ntr y i nt o scree ni n g d oes n ot g uara ntee e nr oll me nt o nt o t he st u d y. T o ma na ge t he t otal st u d y 
e nr oll me nt, Gilea d, at its s ole discreti o n, ma y s us pe n d scree ni n g a n d/ or e nr oll me nt at a n y site or 
st u d y- wi de at a n y ti me.
All patie nts will recei ve ma gr oli ma b + d oceta xel.
6. 2.  
Pretre at me nt Assess me nts
6. 2. 1.  
Scree ni n g Visit
Patie nts will be scree ne d wit hi n 3 0 da ys bef ore d osi n g o n C ycle 1 Da y 1 t o deter mi ne eli gi bilit y 
f or partici pati o n i n t he st u d y. Data fr o m assess me nts perf or me d as part of sta n dar d of care pri or 
t o o btai ni n g i nf or me d c o nse nt si g nat ure ma y be use d if t he y are wit hi n t he re q uire d scree ni n g 
peri o d. T he f oll o wi n g will be perf or me d a n d d oc u me nte d at scree ni n g per A p pe n di x 3 :
•
O btai n writte n i nf or me d c o nse nt
•
O btai n me dical hist or y i ncl u di n g c o nc o mita nt me dicati o ns
•
O btai n de m o gra p hic i nf or mati o n
•
C o m plete p h ysical e xa mi nati o n, i ncl u di n g vital si g ns, b o d y wei g ht, a n d hei g ht
•
O btai n bl o o d a n d uri ne sa m ples f or t he f oll o wi n g tests: c he mistr y, he mat ol o g y, c oa g ulati o n, 
uri nal ysis, ser u m pre g na nc y, e xte n de d R B C p he n ot y pi n g or ge n ot y pi n g, t y pe, a n d scree n, 
a n d direct a nti gl o b uli n test. Bl o o d f or bi o mar ker sa m ples will als o be c ollecte d (ie, P B M C [at 
selecte d sites], ser u m a n d plas ma, a n d w h ole bl o o d R N A).
•
T u m or bi o ps y
•
E C O G
•
Perf or m 1 2-lea d electr ocar di o gra m ( E C G; si n gle)
•
Rec or d all seri o us A Es ( S A Es) a n d A Es relate d t o pr ot oc ol- ma n date d pr oce d ures occ urri n g 
after si g ni n g of t he i nf or me d c o nse nt f or m (I C F)

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 5 7
2 4 Oct o ber 2 0 2 3
Fr o m t he ti me of o btai ni n g i nf or me d c o nse nt t hr o u g h t he first a d mi nistrati o n of st u d y dr u g, 
rec or d all S A Es, as well as a n y A Es relate d t o pr ot oc ol- ma n date d pr oce d ures o n t he A d verse 
E ve nts electr o nic case re p ort f or m (e C R F). All ot her u nt o war d me dical occ urre nces o bser ve d 
d uri n g t he scree ni n g peri o d, i ncl u di n g e xacer bati o n or c ha n ges i n me dical hist or y, are t o be 
c o nsi dere d me dical hist or y. See Secti o n 7 , A d verse E ve nts a n d T o xicit y Ma na ge me nt, f or 
a d diti o nal details.
6. 3.   
R a n d o miz ati o n
Ra n d o mizati o n will n ot be perf or me d i n t his st u d y.
6. 4.  
Tre at me nt Assess me nts
6. 4. 1.  
Pre g n a nc y Test
Pre g na nc y tests are re q uire d o nl y f or fe male patie nts of c hil d beari n g p ote ntial. N ote t hat a 
w o ma n is c o nsi dere d t o be of c hil d beari n g p ote ntial f oll o wi n g t he i nitiati o n of p u bert y ( Ta n ner 
Sta ge 2) u ntil bec o mi n g p ost me n o pa usal, u nless per ma ne ntl y sterile or wit h me dicall y 
d oc u me nte d o varia n fail ure. Per ma ne nt sterilizati o n i ncl u des h ysterect o m y, bilateral 
o o p h orect o m y, or bilateral sal pi n gect o m y i n a fe male patie nt of a n y a ge. W o me n are c o nsi dere d 
t o be i n a p ost me n o pa usal state w he n t he y are ≥ 5 4 years of a ge wit h cessati o n of pre vi o usl y 
occ urri n g me nses f or ≥ 1 2 m o nt hs wit h o ut a n alter nati ve ca use. I n a d diti o n, w o me n of < 5 4 years 
of a ge wit h a me n orr hea of ≥ 1 2 m o nt hs ma y als o be c o nsi dere d p ost me n o pa usal if t heir 
f ollicle-sti m ulati n g h or m o ne le vel is i n t he p ost me n o pa usal ra n ge a n d t he y are n ot usi n g 
h or m o nal c o ntrace pti o n or h or m o nal re place me nt t hera p y. A ne gati ve ser u m pre g na nc y test is 
re q uire d at scree ni n g, a n d a ne gati ve pre g na nc y test is re q uire d pri or t o st u d y treat me nt 
a d mi nistrati o n o n C ycle 1 Da y 1. T he C ycle 1 Da y 1 pre g na nc y test d oes n ot nee d t o be re peate d 
if t he scree ni n g pre g na nc y test was perf or me d wit hi n t he 7 2 h o urs bef ore st u d y treat me nt 
a d mi nistrati o n. Pre g na nc y tests will als o be re q uire d at Da y 1 of eac h s u bse q ue nt c ycle, a n d 
c o nti n ue m o nt hl y u p t o 6 m o nt hs after t he e n d of treat me nt per t he d urati o n of re q uire d 
c o ntrace pti o n as disc usse d i n A p pe n di x 6 . Testi n g d uri n g s ur vi val f oll o w- u p ma y be d o ne at 
h o me a n d t he res ult self-re p orte d b y t he patie nt. F or f urt her details, refer t o A p pe n di x 6 .
6. 4. 2.  
T y pe a n d Scree n a n d Direct A nti gl o b uli n Test
Please refer t o Secti o n 7. 8. 1. 1  f or detaile d g ui da nce o n t y pe a n d scree n a n d direct a nti gl o b uli n 
test. 
6. 4. 3.   
Vit al Si g ns
Vital si g ns are t o i ncl u de heart rate, res pirat or y rate, o x y ge n sat urati o n, bl o o d press ure, 
te m perat ure, a n d wei g ht. Hei g ht will be rec or de d d uri n g scree ni n g o nl y. Wei g ht will be rec or de d 
d uri n g scree ni n g a n d o n Da y 1 of eac h c ycle. Vital si g ns are t o be rec or de d pri or t o 
i nf usi o n/i njecti o n of ma gr oli ma b a n d d oceta xel at t he visits s pecifie d i n t he sc he d ules of 
assess me nts i n A p pe n di x 3 .

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 5 8
2 4 Oct o ber 2 0 2 3
6. 4. 4.  
P h ysic al E x a mi n ati o n
C o m plete p h ysical e xa mi nati o n is t o be perf or me d at scree ni n g. T hereafter, s y m pt o m- directe d 
p h ysical e xa mi nati o ns are acce pta ble a n d ma y als o i ncl u de r o uti ne e xa mi nati o n of t he s ki n 
(i ncl u di n g fi n gers, t oes, a n d ears) a n d ne ur ol o gic s yste m.
6. 4. 5.  
Perf or m a nce St at us
Perf or ma nce stat us will be sc ore d usi n g t he E C O G perf or ma nce stat us scale i n de x (refer t o 
A p pe n di x 7 ).
6. 4. 6.  
Electr oc ar di o gr a ms
A si n gle E C G will be perf or me d at scree ni n g.
6. 4. 7.   
A d verse E ve nts
At eac h visit, all A Es o bser ve d b y t he i n vesti gat or or re p orte d b y t he patie nt t hat occ ur after t he 
first d ose of st u d y treat me nt t hr o u g h 3 0 da ys after t he last d ose of st u d y treat me nt are t o be 
re p orte d usi n g t he a p plica ble e C R F ( Secti o n 7. 1. 1 ). F ull details o n t he defi niti o ns, assess me nt 
a n d re p orti n g i nstr ucti o ns f or A Es are pr o vi de d i n Secti o n 7 .
6. 4. 8.   
C o nc o mit a nt Me dic ati o ns
All c o nc o mita nt me dicati o ns ta ke n b y t he patie nt w hile o n st u d y are t o be d oc u me nte d. C ha n ges 
i n baseli ne c o nc o mita nt me dicati o n i nf or mati o n is t o be c ollecte d after i nf or me d c o nse nt t hr o u g h 
t he st u d y treat me nt peri o d, a n d u p u ntil 3 0 da ys after treat me nt disc o nti n uati o n. C o nc o mita nt 
me dicati o n ass ociate d wit h pr oce d ure-relate d A Es will be ca pt ure d fr o m t he ti me of i nf or me d 
c o nse nt a n d o n war d. I nf or mati o n t o be c ollecte d i ncl u des t hera p y na me, i n dicati o n, r o ute, start 
date, a n d st o p date a n d m ust be re p orte d usi n g t he a p plica ble e C R F. N ote t hat a n y a ntica ncer 
t hera pies after t he st u d y treat me nt peri o d s h o ul d als o be c ollecte d per t he sc he d ules of 
assess me nts ( A p pe n di x 3 ).
6. 5. 
S afet y Assess me nts
Ta ble 9  prese nts a nal ytes t o be assesse d b y t he l ocal a n d/ or ce ntral la b orat or y or s pecialt y 
la b orat ories at scree ni n g. Refer t o Secti o n 7. 8. 1. 1  f or he m o gl o bi n testi n g re q uire me nts f or t he 
first 2 ma gr oli ma b d oses pre d ose a n d p ost d ose m o nit ori n g.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 5 9
2 4 Oct o ber 2 0 2 3
T a ble 9.
Scree ni n g L a b or at or y A n al ytes
C he mistr y
( Ser u m or Pl as m a) 
He m at ol o g y
Uri n al ysis a
Ot her L a b or at or y 
Me as ure me nts
S o di u m
P otassi u m
C hl ori de
Bicar b o nate
T otal pr otei n
Al b u mi n
Calci u m
Ma g nesi u m
P h os p h or us
Gl uc ose
B U N or urea
Creati ni ne
Uric aci d
T otal bilir u bi n
Direct bilir u bi n
I n direct bilir u bi n
A S T ( S G O T)
A L T ( S G P T)
Al kali ne p h os p hatase
R B C
He m o gl o bi n
He mat ocrit
Platelets
W B C t otal
W B C differe ntial
A bs ol ute a n d perce nt 
ne utr o p hil c o u nt
A bs ol ute a n d perce nt 
e osi n o p hils
A bs ol ute a n d perce nt 
bas o p hils
A bs ol ute a n d perce nt 
l y m p h oc ytes
A bs ol ute a n d perce nt 
m o n oc ytes
Retic ul oc ytes
C o a g ul ati o n
P T
I N R
a P T T or P T T
Gl uc ose
Pr otei n
Uri ne p H
Ket o nes
Bilir u bi n
Uri ne s pecific gra vit y
Pre g na nc y (ser u m)
Bl o o d t y pe a n d scree n 
( A B O/ R h), D A T, a n d 
E xte n de d R B C p he n ot y pi n g 
or ge n ot y pi n g 
A B O = a n y of t he 4 bl o o d gr o u ps A, B, A B, a n d O c o m prisi n g t he A B O s yste m; A L T = ala ni ne a mi n otra nsferase; 
a P T T = acti vate d partial t hr o m b o plasti n ti me; A S T = as partate a mi n otra nsferase; B U N = bl o o d urea nitr o ge n; D A T = direct 
a nti gl o b uli n test; I N R = i nter nati o nal n or malize d rati o; P T = pr ot hr o m bi n ti me; P T T = partial t hr o m b o plasti n ti me; R B C = re d 
bl o o d cell; R h = r hes us; S G O T = ser u m gl uta mic o xal oacetic tra nsa mi nase; S G P T = ser u m gl uta mic p yr u vic tra nsa mi nase; 
W B C = w hite bl o o d cell
N ote: A nal ytes are re q uire d t o be c ollecte d at scree ni n g. Refer t o A p pe n di x Ta ble 1  f or c ollecti o n ti me p oi nts.
a  
Refle x micr osc o pic testi n g base d o n ot her a b n or malities.
Ta ble 1 0  prese nts a nal ytes t o be assesse d b y t he l ocal a n d/ or ce ntral la b orat or y or s pecialt y 
la b orat ories d uri n g t he st u d y.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 6 0
2 4 Oct o ber 2 0 2 3
T a ble 1 0.
St u d y L a b or at or y A n al ytes 
C he mistr y 
( Ser u m or Pl as m a)
He m at ol o g y
Ot her L a b or at or y Me as ure me nts
S o di u m
P otassi u m
C hl ori de
Bicar b o nate
T otal pr otei n
Al b u mi n
Calci u m
Ma g nesi u m
P h os p h or us
Gl uc ose
B U N or urea
Creati ni ne
Uric aci d
T otal bilir u bi n
Direct bilir u bi n
I n direct bilir u bi n
A S T ( S G O T)
A L T ( S G P T)
Al kali ne p h os p hatase
Ha pt o gl o bi n
L D H
R B C
He m o gl o bi n
He mat ocrit
Platelets
W B C t otal
W B C differe ntial
A bs ol ute a n d perce nt ne utr o p hil 
c o u nt
A bs ol ute a n d perce nt e osi n o p hils
A bs ol ute a n d perce nt bas o p hils
A bs ol ute a n d perce nt l y m p h oc ytes
A bs ol ute a n d perce nt m o n oc ytes
Retic ul oc ytes
Pre g na nc y ( uri ne or ser u m)
Bl o o d sa m ples c orrelati ve st u dies  a
P har mac o ki netics
A nti dr u g a nti b o dies  a
A B O = a n y of t he 4 bl o o d gr o u ps A, B, A B, a n d O c o m prisi n g t he A B O s yste m; A L T = ala ni ne a mi n otra nsferase; 
A S T = as partate a mi n otra nsferase; B U N = bl o o d urea nitr o ge n; L D H = lactate de h y dr o ge nase; R B C = re d bl o o d cell; 
R h = r hes us; S G O T = ser u m gl uta mic o xal oacetic tra nsa mi nase; S G P T = ser u m gl uta mic p yr u vic tra nsa mi nase; W B C = w hite 
bl o o d cell
N ote: A nal ytes are re q uire d t o be c ollecte d at visits d uri n g st u d y. Refer t o A p pe n di x Ta ble 1  f or c ollecti o n ti me p oi nts.
a  
T hese assa ys will be perf or me d at a ce ntral la b orat or y.
6. 6.  
Effic ac y Assess me nts
Eit her c o ntrast-e n ha nce d c o m p ute d t o m o gra p h y ( C T), ga d oli ni u m-e n ha nce d ma g netic res o na nce 
i ma gi n g, or p ositr o n e missi o n t o m o gra p h y- C T (t hat i ncl u des a c o ntrast-e n ha nce d C T 
c o m p o ne nt) of t he c hest, a b d o me n, a n d pel vis will be perf or me d at scree ni n g, e ver y 9 wee ks 
( 2 1- da y d osi n g c ycle) d uri n g t he st u d y (starti n g fr o m C ycle 1 Da y 1) a n d at t he e n d- of-treat me nt 
( E O T) visit if o ne has n ot bee n perf or me d wit hi n t he last 3 0 da ys or pr o gressi ve disease has bee n 
d oc u me nte d. T he o n-treat me nt i ma gi n g wi n d o w is ± 7 da ys. T u m or b ur de n will be e val uate d 
s olel y base d o n ra di o gra p hic i ma gi n g per R E CI S T, Versi o n 1. 1. C hest x-ra y, ultras o u n d, 
e n d osc o p y, la par osc o p y, p ositr o n-e missi o n t o m o gra p h y, ra di o n ucli de sca ns, or t u m or mar kers 
will n ot be c o nsi dere d f or res p o nse assess me nt.
F or ra di o gra p hic e val uati o ns, t he sa me met h o d of assess me nt a n d t he sa me tec h ni q ue 
(e g, sca n t y pe, sca n ner, patie nt p ositi o n, d ose of c o ntrast, i njecti o n/sca n i nter val) s h o ul d be use d 
t o c haracterize eac h i de ntifie d a n d re p orte d lesi o n at baseli ne a n d d uri n g st u d y treat me nt a n d 
f oll o w- u p.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 6 1
2 4 Oct o ber 2 0 2 3
Sca ns ta ke n as part of sta n dar d me dical practice u p t o 3 0 da ys pri or t o e nr oll me nt ca n be use d f or 
scree ni n g as l o n g as t he y meet all st u d y re q uire me nts. D uri n g t he treat me nt p hase, sca ns ma y be 
perf or me d at ti me p oi nts ot her t ha n e ver y 9 wee ks ( 2 1- da y d osi n g c ycle) as cli nicall y i n dicate d 
t o assess t u m or pr o gressi o n.
F or patie nts w h o st o p st u d y treat me nt n ot relate d t o ra di o gra p hic disease pr o gressi o n (e g, 
e x perie nce d u ne x pecte d t o xicit y), sca ns s h o ul d c o nti n ue t o be c ollecte d a p pr o xi matel y e ver y 
9 wee ks ( 2 1- da y d osi n g c ycle) u ntil ra di o gra p hic disease pr o gressi o n (ie, pre pr o gressi o n visit 
[A p pe n di x Ta ble 2 ]) or i nitiati o n of s yste mic a ntit u m or t hera p y ot her t ha n t he st u d y treat me nt, 
w hic he ver i s earlier. Pre- pr o gressi o n visits will be c o m plete d first bef ore pr ocee di n g t o s ur vi val 
f oll o w- u p.
All rele va nt cli nical a n d ra di o gra p hic i nf or mati o n re q uire d t o ma ke eac h assess me nt m ust be 
ma de a vaila ble f or s o urce verificati o n. Disease pr o gressi o n will be deter mi ne d b y t he 
i n vesti gat or or q ualifie d desi g nee.
Patie nts will be assesse d f or res p o nse usi n g R E CI S T, Versi o n 1. 1 { Eise n ha uer 2 0 0 9 } f or t he 
pri mar y e fficac y e n d p oi nt a n d f or t he sec o n dar y efficac y e n d p oi nt (A p pe n di x 8 ).
6. 7.  
P h ar m ac o ki netic Assess me nts
Ma gr oli ma b ser u m c o nce ntrati o n will be meas ure d b y a vali date d e nz y me-li n ke d i m m u n os or be nt 
assa y ( E LI S A) i m m u n oassa y met h o d.
Bl o o d sa m ples f or P K assess me nt will be c ollecte d pre d ose at m ulti ple ti me p oi nts acc or di n g t o 
t he sc he d ules of assess me nts i n A p pe n di x Ta ble 3  ( n ote t he a d diti o nal sa m ple c ollecte d p ost d ose 
o n C ycle 3 Da y 1 at 1 h ± 1 5 mi n after t he e n d of ma gr oli ma b i nf usi o n). Resi d ual sa m ples use d 
f or P K a n d A D A a nal ysis ma y als o be use d f or   
 P K or P D a nal yses relate d t o 
ma gr oli ma b treat me nt al o ne as well as c o m bi nati o n t hera p y wit h a ntica ncer c he m ot hera pies. 
T his c o ul d i ncl u de usi n g left o ver ser u m f or   
 alter nati ve P K assa y de vel o p me nt a n d 
a nal ysis.
6. 8.  
I m m u n o ge nicit y ( A nti dr u g A nti b o dies)
Peri p heral bl o o d f or i m m u n o ge nicit y assess me nts f or A D A a gai nst ma gr oli ma b will be c ollecte d 
as descri be d i n t he sc he d ules of assess me nts f or all patie nts ( A p pe n di x Ta ble 3 ). W he n c ollecte d 
o n t he da y of st u d y dr u g d osi n g, t he A D A bl o o d sa m ple m ust be c ollecte d at t he sa me ti me as t he 
pre d ose P K sa m ple. T he prese nce of a nti- ma gr oli ma b a nti b o dies will be deter mi ne d b y a 
vali date d electr oc he mil u mi nesce nce i m m u n oassa y met h o d.
6. 9.  
Bi o m ar ker Assess me nts
Bi o mar ker sa m ples will be c ollecte d t o assess t he P D, M O A, a n d treat me nt res p o nse bi o mar kers, 
a n d t o defi ne c orrelates of cli nical efficac y a n d/ or safet y, as o utli ne d i n Secti o n 3. 8 . T he 
bi o mar ker sa m ple c ollecti o n sc he d ule is o utli ne d i n A p pe n di x Ta ble 3 .
C CI
C CI--

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 6 2
2 4 Oct o ber 2 0 2 3
Patie nts are re q uire d t o s u b mit a ma n dat or y pretreat me nt c ore nee dle or e xcisi o nal t u m or bi o ps y 
(fi ne nee dle as pirate is n ot a de q uate) fr o m a site n ot pre vi o usl y irra diate d, u nless n ot feasi ble as 
deter mi ne d b y t he i n vesti gat or a n d disc usse d wit h t he s p o ns or. A ne wl y o btai ne d bi o ps y, 
c ollecte d wit hi n 9 0 da ys pri or t o st u d y treat me nt start, is str o n gl y preferre d, b ut a n arc hi val 
sa m ple is acce pta ble. F or arc hi val sa m ples s u b mitte d i n lie u of ne wl y o btai ne d bi o psies, tiss ue 
c ollecte d wit hi n 6 m o nt hs pri or t o st u d y treat me nt start is str o n gl y preferre d w he ne ver p ossi ble.
Patie nts will als o s u b mit a ma n dat or y o n-treat me nt c ore nee dle or e xcisi o nal t u m or bi o ps y u nless 
n ot feasi ble as deter mi ne d b y t he i n vesti gat or a n d disc usse d wit h t he s p o ns or.
F or a d diti o nal details a n d i nstr ucti o ns re gar di n g tiss ue re q uire me nts a n d pr oce d ures f or sa m ple 
c ollecti o n, st ora ge, a n d s hi p me nt, refer t o t he St u d y La b orat or y Ma n ual.
6. 1 0.  
P osttre at me nt Assess me nts
P osttreat me nt assess me nts are pr o vi de d i n A p pe n di x Ta ble 2 . T here are 2 t y pes of f oll o w- u p 
visit: safet y f oll o w- u p ( 3 0 da ys [ ± 7 da ys] after t he last d ose of st u d y dr u g) a n d s ur vi val 
f oll o w- u p (e ver y 2 m o nt hs after safet y f oll o w- u p [ ± 7 da ys]). Patie nts w h o disc o nti n ue st u d y 
treat me nt are t o ret ur n f or a n E O T visit f or e val uati o n of safet y wit hi n 7 da ys of t heir last d ose or 
t he decisi o n t o e n d st u d y treat me nt. I n a d diti o n, patie nts are t o ha ve a safet y f oll o w- u p tele p h o ne 
call 3 0 da ys ( ± 7 da ys) after t heir last d ose of st u d y treat me nt. W he n a seri o us a d verse e ve nt 
( S A E) or treat me nt-relate d A E is re p orte d d uri n g t he tele p h o ne call, t he patie nt s h o ul d c o me t o 
t he cli nic f or p h ysical e xa mi nati o n a n d bl o o d tests, if cli nicall y nee de d. F oll o w- u p f or o n g oi n g 
S A Es or treat me nt-relate d A Es after t he safet y f oll o w- u p visit/call will st o p if a patie nt be gi ns 
a n ot her a ntica ncer t hera p y. Pre g na nc y testi n g will c o nti n ue m o nt hl y u p t o 6 m o nt hs after t he e n d 
of treat me nt per t he d urati o n of re q uire d c o ntrace pti o n as disc usse d i n A p pe n di x 6 . Testi n g 
d uri n g s ur vi val f oll o w- u p ma y be d o ne at h o me a n d t he res ult self-re p orte d b y t he patie nt. 
S ur vi val f oll o w- u p will be c o n d ucte d via a p h o ne call e ver y 2 m o nt hs u ntil deat h or e n d of st u d y. 
D urati o n of s ur vi val f oll o w- u p will be li mite d t o 3 years.
6. 1 1.   
Assess me nts f or E arl y Disc o nti n u ati o n Fr o m St u d y
If a patie nt disc o nti n ues st u d y d osi n g (f or e xa m ple, as a res ult of a n A E), e ver y atte m pt s h o ul d 
be ma de t o kee p t he patie nt i n t he st u d y a n d c o nti n ue t o perf or m t he re q uire d st u d y-relate d 
f oll o w- u p a n d pr oce d ures ( Secti o n 6. 1 1. 1 , Criteria f or Disc o nti n uati o n of St u d y Treat me nt). I n 
t he a bse nce of disease pr o gressi o n, sca ns s h o ul d c o nti n ue t o be c ollecte d per Secti o n 6. 6  
Efficac y Assess me nt, u ntil disease pr o gressi o n or i nitiati o n of s yste mic a ntit u m or t hera p y ot her 
t ha n t he st u d y treat me nt, w hic he ver is earlier. If t his is n ot p ossi ble or acce pta ble t o t he patie nt or 
i n vesti gat or, t he patie nt ma y be wit h dra w n fr o m t he st u d y. F or patie nts w h o disc o nti n ue fr o m t he 
st u d y pri or t o c o m pleti o n of all pr ot oc ol-re q uire d visits f or st u d y assess me nts or s ur vi val 
f oll o w- u p as descri be d i n t he sc he d ule of assess me nts (A p pe n di x Ta ble 2 ), t he i n vesti gat or ma y 
searc h p u blicl y a vaila ble rec or ds ( w here per mitte d b y l ocal la ws a n d re g ulati o ns) t o ascertai n 
s ur vi val stat us u nless t he patie nt wit h dra ws c o nse nt f or s uc h f oll o w- u p. T his e ns ures re d uce d 
ris k of missi n g critical efficac y data.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 6 3
2 4 Oct o ber 2 0 2 3
6. 1 1. 1.   
Criteri a f or Disc o nti n u ati o n of St u d y Tre at me nt
Criteria f or disc o nti n uati o n of st u d y treat me nt is pr o vi de d i n i n Secti o n 3. 4 .
6. 1 2.   
Criteri a f or Disc o nti n u ati o n Fr o m St u d y/ E n d of St u d y
Criteria f or disc o nti n uati o n fr o m st u d y is pr o vi de d i n Secti o n 3. 5 .
6. 1 3. 
P ostst u d y C are
U p o n wit h dra wal fr o m st u d y treat me nt, patie nts will recei ve t he care u p o n w hic h t he y a n d t heir 
p h ysicia ns a gree. Patie nts will be f oll o we d f or disease pr o gressi o n if a p plica ble, s ur vi val, a n d 
A Es as s pecifie d i n A p pe n di x Ta ble 1 . P ostst u d y treat me nt assess me nts are descri be d i n 
A p pe n di x Ta ble 2 .
6. 1 4.  
S a m ple St or a ge
T he st ore d bi ol o gical sa m ples ma y be use d b y Gilea d or its researc h part ner f or  
 testi n g t o 
pr o vi de a d diti o nal data t o a ns wer q uesti o ns t hat relate t o t he mai n st u d y. At t he e n d of t his st u d y, 
t hese sa m ples ma y be retai ne d i n st ora ge b y Gilea d f or a peri o d u p t o 1 5 years. If patie nts 
pr o vi de a d diti o nal s pecific c o nse nt, resi d ual P K sa m ples ma y be destr o ye d n o later t ha n 1 5 years 
after t he e n d of st u d y or per c o u ntr y re q uire me nts.
C CI-

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 6 4
2 4 Oct o ber 2 0 2 3
7.   
A D V E R S E E V E N T S A N D T O XI CI T Y M A N A G E M E N T
7. 1.   
Defi niti o ns of A d verse E ve nts a n d Seri o us A d verse E ve nts
7. 1. 1.   
A d verse E ve nts
A n A E is a n y u nt o war d me dical occ urre nce i n a cli nical st u d y patie nt a d mi nistere d a st u d y dr u g 
t hat d oes n ot necessaril y ha ve a ca usal relati o ns hi p wit h t he treat me nt. A n A E ca n t heref ore be 
a n y u nfa v ora ble a n d/ or u ni nte n de d si g n, s y m pt o m, or disease te m p orall y ass ociate d wit h t he use 
of a st u d y dr u g, w het her or n ot t he A E is c o nsi dere d relate d t o t he st u d y dr u g. A d verse e ve nts 
ma y als o i ncl u de pretreat me nt or p osttreat me nt c o m plicati o ns t hat occ ur as a res ult of 
pr ot oc ol-s pecifie d pr oce d ures or s pecial sit uati o ns ( Secti o n 7. 1. 3 ). A n A E d oes n ot i ncl u de t he 
f oll o wi n g:
•
Me dical or s ur gical pr oce d ures s uc h as s ur ger y, e n d osc o p y, t o ot h e xtracti o n, a n d tra nsf usi o n. 
T he c o n diti o n t hat le d t o t he pr oce d ure ma y be a n A E a n d m ust be re p orte d.
•
Pree xisti n g diseases, c o n diti o ns, or la b orat or y a b n or malities prese nt or detecte d bef ore t he 
scree ni n g visit t hat d o n ot w orse n
•
Sit uati o ns w here a n u nt o war d me dical occ urre nce has n ot occ urre d (e g, h os pitalizati o n f or 
electi ve s ur ger y, s ocial a n d/ or c o n ve nie nce a d missi o ns)
•
O ver d ose wit h o ut cli nical se q uelae ( Secti o n 7. 1. 3 )
•
A n y me dical c o n diti o n or cli nicall y si g nifica nt la b orat or y a b n or malit y wit h a n o nset date 
bef ore t he I C F is si g ne d a n d n ot relate d t o a pr ot oc ol-ass ociate d pr oce d ure is n ot a n A E b ut 
rat her c o nsi dere d t o be pree xisti n g a n d s h o ul d be d oc u me nte d as me dical hist or y.
Pree xisti n g e ve nts t hat i ncrease i n se verit y or c ha n ge i n nat ure after st u d y dr u g i nitiati o n or as a 
c o nse q ue nce of partici pati o n i n t he cli nical st u d y will als o be c o nsi dere d A Es.
7. 1. 2.  
Seri o us A d verse E ve nts
A n S A E is defi ne d as a n e ve nt t hat, at a n y d ose, res ults i n t he f oll o wi n g:
•
Deat h
•
A life-t hreate ni n g sit uati o n ( N ote: T he ter m “life-t hreate ni n g” i n t he defi niti o n of “seri o us” 
refers t o a n e ve nt i n w hic h t he patie nt was at ris k of deat h at t he ti me of t he e ve nt; it d oes n ot 
refer t o a n e ve nt t hat h y p ot heticall y mi g ht ha ve ca use d deat h if it were m ore se vere.)
•
I n- patie nt h os pitalizati o n or pr ol o n gati o n of e xisti n g h os pitalizati o n
•
Persiste nt or si g nifica nt disa bilit y/i nca pacit y

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 6 5
2 4 Oct o ber 2 0 2 3
•
A c o n ge nital a n o mal y/ birt h defect
•
A me dicall y i m p orta nt e ve nt or reacti o n: S uc h e ve nts ma y n ot be i m me diatel y 
life-t hreate ni n g or res ult i n deat h or h os pitalizati o n b ut ma y je o par dize t he patie nt or ma y 
re q uire i nter ve nti o n t o pre ve nt o ne of t he ot her o utc o mes c o nstit uti n g S A Es. Me dical a n d 
scie ntific j u d g me nt m ust be e xercise d t o deter mi ne w het her s uc h a n e ve nt is re p orta ble u n der 
e x pe dite d re p orti n g r ules. E xa m ples of me dicall y i m p orta nt e ve nts i ncl u de i nte nsi ve 
treat me nt i n a n e mer ge nc y r o o m or at h o me f or aller gic br o nc h os pas m; bl o o d d yscrasias or 
c o n v ulsi o ns t hat d o n ot res ult i n h os pitalizati o n; a n d de vel o p me nt of dr u g de pe n de nc y or 
dr u g a b use.
7. 1. 2. 1.  
Pr ot oc ol- S pecific A d verse E ve nt/ Seri o us A d verse E ve nt Clarificati o ns
Gi ve n pr o gressi o n of disease is o ne of t he e n d p oi nts of t he st u d y, i n or der t o mai ntai n st u d y 
i nte grit y, t he f oll o wi n g e ve nts t hat are assesse d as u nrelate d t o st u d y dr u g will n ot be c o nsi dere d 
A Es/ S A Es:
•
Pr o gressi o n of disease
•
Deat hs relate d t o pr o gressi o n of disease
E ve nts t hat are c o nsi dere d t o re prese nt pr o gressi o n of disease s h o ul d n ot be rec or de d as 
A Es/ S A Es u nless it is assesse d t hat st u d y dr u gs c o ntri b ute d t o disease pr o gressi o n. T hese data 
will be ca pt ure d as efficac y assess me nt data o nl y. If t here is a n y u ncertai nt y as t o w het her a n 
e ve nt is d ue t o disease pr o gressi o n, it s h o ul d be re p orte d as a n A E/ S A E.
Deat h t hat is attri b ute d b y t he i n vesti gat or as s olel y d ue t o disease pr o gressi o n a n d t hat occ urs 
d uri n g t he pr ot oc ol-s pecifie d A E re p orti n g peri o d s h o ul d be rec or de d o nl y o n t he deat h e C R F 
(ie, n ot c ollecte d as a n S A E o n t he A E e C R F).
7. 1. 2. 1. 1.   
Deat hs N ot Relate d t o Disease Pr o gressi o n
All ot her deat hs (ie, deat hs t hat are n ot d ue t o disease pr o gressi o n) occ urri n g d uri n g t he 
pr ot oc ol-s pecifie d A E re p orti n g peri o d, re gar dless of attri b uti o n, will be rec or de d o n t he A E 
e C R F a n d re p orte d wit hi n 2 4 h o urs of a ware ness a n d n o later t ha n t he ne xt b usi ness da y.
W he n rec or di n g a deat h o n t he e C R F, t he e ve nt or c o n diti o n t hat is c o nsi dere d t he pri mar y ca use 
of deat h s h o ul d be t he A E ter m, a n d t he o utc o me s h o ul d be deat h. A patie nt ca n o nl y ha ve 1 A E 
( S A E) wit h o utc o me of deat h a n d se verit y of C T C A E Gra de 5.
7. 1. 3.  
St u d y Dr u gs a n d Gile a d C o nc o mit a nt T her a p y S peci al Sit u ati o ns Re p orts
S pecial sit uati o n re p orts ( S S Rs) i ncl u de all re p orts of me dicati o n err or, a b use, mis use, o ver d ose, 
occ u pati o nal e x p os ure, dr u g i nteracti o ns, e x p os ure via breastfee di n g, u ne x pecte d be nefit, 
tra ns missi o n of i nfecti o us a ge nts via t he pr o d uct, c o u nterfeit or falsifie d me dici ne, a n d 
pre g na nc y re gar dless of a n ass ociate d A E.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 6 6
2 4 Oct o ber 2 0 2 3
Me dicati o n err or is a n y u ni nte nti o nal err or i n t he prescri bi n g, dis pe nsi n g, pre parati o n f or 
a d mi nistrati o n, or a d mi nistrati o n of a st u d y dr u g w hile t he me dicati o n is i n t he c o ntr ol of a 
healt h care pr ofessi o nal, patie nt, or c o ns u mer. Me dicati o n err ors ma y be classifie d as a 
me dicati o n err or wit h o ut a n A E, w hic h i ncl u des sit uati o ns of misse d d ose, me dicati o n err or wit h 
a n A E, i nterce pte d me dicati o n err or, or p ote ntial me dicati o n err or.
A b use is defi ne d as persiste nt or s p ora dic i nte nti o nal e xcessi ve use of a st u d y dr u g b y a patie nt.
Mis use is defi ne d as a n y i nte nti o nal a n d i na p pr o priate use of a st u d y dr u g t hat is n ot i n 
acc or da nce wit h t he pr ot oc ol i nstr ucti o ns or t he l ocal prescri bi n g i nf or mati o n.
A n o ver d ose is defi ne d as a n acci de ntal or i nte nti o nal a d mi nistrati o n of a q ua ntit y of a st u d y 
dr u g gi ve n per a d mi nistrati o n or c u m ulati vel y t hat is a b o ve t he ma xi m u m rec o m me n de d d ose as 
per pr ot oc ol or i n t he pr o d uct la beli n g (as it a p plies t o t he dail y d ose of t he patie nt i n q uesti o n). 
I n cases of a discre pa nc y i n dr u g acc o u nta bilit y, o ver d ose will be esta blis he d o nl y w he n it is 
clear t hat t he patie nt has ta ke n t he e xcess d ose(s). O ver d ose ca n n ot be esta blis he d w he n t he 
patie nt ca n n ot acc o u nt f or t he discre pa nc y, e xce pt i n cases i n w hic h t he i n vesti gat or has reas o n 
t o s us pect t hat t he patie nt has ta ke n t he a d diti o nal d ose(s).
Occ u pati o nal e x p os ure is defi ne d as e x p os ure t o a st u d y dr u g as a res ult of o ne’s pr ofessi o nal or 
n o n pr ofessi o nal occ u pati o n.
Dr u g i nteracti o n is defi ne d as a n y dr u g/ dr u g, dr u g/f o o d, or dr u g/ de vice i nteracti o n.
U ne x pecte d be nefit is defi ne d as a n u ni nte n de d t hera pe utic effect w here t he res ults are j u d ge d t o 
be desira ble a n d be neficial.
Tra ns missi o n of i nfecti o us a ge nts is defi ne d as a n y s us pecte d tra ns missi o n of a n i nfecte d a ge nt 
t hr o u g h a Gilea d st u d y dr u g.
C o u nterfeit or falsifie d me dici ne is defi ne d as a n y st u d y dr u g wit h a false re prese ntati o n of (a) its 
i de ntit y, ( b) its s o urce, or (c) its hist or y.
7. 2.   
Assess me nt of A d verse E ve nts a n d Seri o us A d verse E ve nts
T he i n vesti gat or or q ualifie d s u bi n vesti gat or is res p o nsi ble f or assessi n g A Es a n d S A Es f or 
ca usalit y a n d se verit y, a n d f or fi nal re vie w a n d c o nfir mati o n of acc urac y of e ve nt i nf or mati o n 
a n d assess me nts.
7. 2. 1.   
Assess me nt of C a us alit y f or St u d y Dr u gs, A ut h orize d A x M Ps, a n d 
Pr oce d ures
T he i n vesti gat or or q ualifie d s u bi n vesti gat or is res p o nsi ble f or assessi n g t he relati o ns hi p t o st u d y 
dr u g a n d A x M P usi n g cli nical j u d g me nt a n d t he f oll o wi n g c o nsi derati o ns:
•
N o : E vi de nce e xists t hat t he A E has a n eti ol o g y ot her t ha n t he st u d y dr u g. F or S A Es, a n 
alter nati ve ca usalit y m ust be pr o vi de d (e g, pree xisti n g c o n diti o n, u n derl yi n g disease, 
i nterc urre nt ill ness, or c o nc o mita nt me dicati o n).
•
Yes : T here is reas o na ble p ossi bilit y t hat t he e ve nt ma y ha ve bee n ca use d b y t he st u d y dr u g.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 6 7
2 4 Oct o ber 2 0 2 3
It s h o ul d be e m p hasize d t hat i neffecti ve treat me nt s h o ul d n ot be c o nsi dere d as ca usall y relate d i n 
t he c o nte xt of A E re p orti n g.
T he relati o ns hi p t o st u d y pr oce d ures (e g, i n vasi ve pr oce d ures s uc h as ve ni p u nct ure or bi o ps y) 
s h o ul d be assesse d usi n g t he f oll o wi n g c o nsi derati o ns:
•
N o: E vi de nce  e xists t hat t he A E has a n eti ol o g y ot her t ha n t he st u d y pr oce d ure.
•
Yes:  T he A E occ urre d as a res ult of pr ot oc ol pr oce d ures (e g, ve ni p u nct ure).
W he n t here is a reas o na ble p ossi bilit y t hat t he ca usalit y of t he A E/ S A E ca n be assi g ne d t o t he 
a ut h orize d A x M P, t he i n vesti gat or or q ualifie d s u bi n vesti gat or will nee d t o re p ort t he ca usalit y 
assess me nt f or t he a ut h orize d A x M Ps i n acc or da nce wit h t he e C R F.
7. 2. 2.   
Assess me nt of Se verit y
T he se verit y of A Es will be gra de d usi n g t he N CI C T C A E, Versi o n 5. 0. F or eac h e pis o de, t he 
hi g hest gra de attai ne d s h o ul d be re p orte d as defi ne d i n t he T o xicit y Gra di n g Scale ( A p pe n di x 5 ).
7. 3.  
I n vesti g at or Re p orti n g Re q uire me nts a n d I nstr ucti o ns
7. 3. 1.   
Re q uire me nts f or C ollecti o n Pri or t o St u d y Dr u g I niti ati o n
After i nf or me d c o nse nt, b ut pri or t o i nitiati o n of st u d y me dicati o n, t he f oll o wi n g t y pes of e ve nts 
m ust be re p orte d o n t he a p plica ble e C R Fs: all S A Es a n d A Es relate d t o pr ot oc ol- ma n date d 
pr oce d ures.
7. 3. 2.   
A d verse E ve nts
F oll o wi n g i nitiati o n of st u d y me dicati o n, all A Es, re gar dless of ca use or relati o ns hi p, will be 
c ollecte d u ntil 3 0 da ys after last a d mi nistrati o n of st u d y dr u g a n d re p orte d o n t he e C R Fs as 
i nstr ucte d.
All A Es will be f oll o we d u p u ntil res ol uti o n or u ntil t he A E is sta ble, if p ossi ble. Gilea d ma y 
re q uest t hat certai n A Es be f oll o we d be y o n d t he pr ot oc ol- defi ne d f oll o w- u p peri o d.
7. 3. 3.  
Seri o us A d verse E ve nts
All S A Es, re gar dless of ca use or relati o ns hi p, t hat occ ur after t he patie nt first c o nse nts t o 
partici pate i n t he st u d y (ie, si g ni n g t he I C F) a n d t hr o u g h o ut t he d urati o n of t he st u d y, i ncl u di n g 
t he p osttreat me nt f oll o w- u p visit, m ust be re p orte d o n t he a p plica ble e C R Fs a n d t o Gilea d 
Patie nt Safet y ( P S) as i nstr ucte d bel o w i n t his secti o n. T his als o i ncl u des a n y S A Es res ulti n g 
fr o m pr ot oc ol-ass ociate d pr oce d ures perf or me d after t he I C F is si g ne d.
A n y S A Es a n d deat hs t hat occ ur after t he p osttreat me nt f oll o w- u p visit b ut wit hi n 3 0 da ys of t he 
last d ose of st u d y dr u g, re gar dless of ca usalit y, s h o ul d als o be re p orte d.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 6 8
2 4 Oct o ber 2 0 2 3
I n vesti gat ors are n ot o bli gate d t o acti vel y see k S A Es after t he pr ot oc ol- defi ne d f oll o w- u p peri o d; 
h o we ver, if t he i n vesti gat or lear ns of a n y S A Es t hat occ ur after t he pr ot oc ol- defi ne d f oll o w- u p 
peri o d has c o ncl u de d a n d t he e ve nt is dee me d rele va nt t o t he use of st u d y dr u g, t he i n vesti gat or 
s h o ul d pr o m ptl y d oc u me nt a n d re p ort t he e ve nt t o Gilea d P S.
I nstr ucti o ns f or re p orti n g S A Es are descri be d i n Secti o n 7. 4. 1 .
7. 3. 4.  
St u d y Dr u g S peci al Sit u ati o ns Re p orts
All st u d y dr u g S S Rs t hat occ ur fr o m st u d y dr u g i nitiati o n a n d t hr o u g h o ut t he d urati o n of t he 
st u d y, i ncl u di n g t he p osttreat me nt f oll o w- u p visit, m ust be re p orte d t o Gilea d P S ( Secti o n 7. 4. 2 ). 
A d verse e ve nts a n d S A Es res ulti n g fr o m S S Rs m ust be re p orte d i n acc or da nce wit h t he A E a n d 
S A E re p orti n g g ui da nce ( Secti o n 7. 4 ).
7. 3. 5.   
C o nc o mit a nt T her a p y Re p orts
7. 3. 5. 1.   
Gilea d C o nc o mita nt T hera p y S pecial Sit uati o ns Re p ort
S pecial sit uati o ns i n v ol vi n g a Gilea d c o nc o mita nt t hera p y ( n ot c o nsi dere d st u d y dr u g) t hat occ ur 
after t he patie nt first c o nse nts t o partici pate i n t he st u d y (ie, si g ni n g t he i nf or me d c o nse nt) a n d 
t hr o u g h o ut t he d urati o n of t he st u d y, i ncl u di n g t he p osttreat me nt f oll o w- u p visit, m ust be 
re p orte d t o Gilea d P S utilizi n g t he pa per S S R f or m ( Secti o n 7. 4. 2. 2 ).
7. 3. 5. 2.   
N o n- Gilea d C o nc o mita nt T hera p y Re p ort
S pecial sit uati o ns i n v ol vi n g n o n- Gilea d c o nc o mita nt me dicati o ns d o n ot nee d t o be re p orte d o n 
t he S S R f or m; h o we ver, f or s pecial sit uati o ns t hat res ult i n A Es d ue t o a n o n- Gilea d c o nc o mita nt 
me dicati o n, t he A E s h o ul d be re p orte d o n t he A E f or m.
A n y i na p pr o priate use of c o nc o mita nt me dicati o ns pr o hi bite d b y t his pr ot oc ol s h o ul d n ot be 
re p orte d as “ mis use,” b ut ma y be m ore a p pr o priatel y d oc u me nte d as a pr ot oc ol de viati o n.
All cli nical se q uelae i n relati o n t o t hese S S Rs will be re p orte d as A Es or S A Es at t he sa me ti me 
usi n g t he A E e C R F a n d/ or t he S A E re p ort f or m. Details of t he s y m pt o ms a n d si g ns, cli nical 
ma na ge me nt, a n d o utc o me will be re p orte d, w he n a vaila ble.
7. 4.   
Re p orti n g Pr ocess f or Seri o us A d verse E ve nts a n d S peci al Sit u ati o n Re p orts
7. 4. 1.  
Seri o us A d verse E ve nt Re p orti n g Pr ocess
F or fatal or life-t hreate ni n g e ve nts, c o pies of h os pital case re p orts, a ut o ps y re p orts, a n d ot her 
d oc u me nts are als o t o be tra ns mitte d b y e mail or fa x w he n re q ueste d a n d a p plica ble. 
Tra ns missi o n of s uc h d oc u me nts s h o ul d occ ur wit h o ut pers o nal patie nt i de ntificati o n, 
mai ntai ni n g t he tracea bilit y of a d oc u me nt t o t he patie nt i de ntifiers.
A d diti o nal i nf or mati o n ma y be re q ueste d t o e ns ure t he ti mel y c o m pleti o n of acc urate safet y 
re p orts.

M a gr oli m a b 
Gil e a d  S ci e n c e s , I n c. 
Pr o to c ol  G S -U S- 5 4 8 -5 9 1 8 
A m e n d m e nt s 
A n y  m e di c ati o ns  n e c e s s ai y  f or tr e atm e nt of th e  S A E  m u st b e r e c or d ed  o n t o t h e c o n c o mi t a nt 
m e di c at i o n s e ctio n of t h e p ati e n t' s e C R F  a n d t h e  S A E  n a n at iv e s e cti o n of t h e S af et y  R e p o 1t 
F o n n e C R F . 
7. 4. 1. 1.  
El e ctr o n i c S e ri ous  A d v er s e  E v e nt  R e p o rti ng  P r o c ess 
Sit e  p er s o n n el  wi ll r e c or d  all S A E  d at a  o n t h e  a p p li c a bl e e C R F s  a n d fro m t h er e  tr an s mit t he  S A E 
i nf on n ati o n t o Gi le a d  P S  wit h i n 2 4 h o ur s of th e  i nv e s tig at or' s  k n o wl e d g e of t h e e v e nt  fr o m IC F 
si g n atur e t h r ou g h o ut t h e  d ur at i o n of t h e st u d y , i ncl u di ng t h e  pr ot o c ol -r e quir e d p o stt re at m e nt 
f ollo w - u p p er i o d. 
If it is n ot  p o s si bl e  t o re c o r d  a n d tr a n s mit t h e S A E  i nf on n ati o n  el e ctr o n i c ally, r e c o r d t he  S A E  o n 
t h e p a p e r S A E  r ep o 1ti n g f o 1 m a n d t r a n s mit wit hi n 2 4 h o ur s: 
Gi l e a d: 
P P D 
If a n  S A E  h as  b e e n r e p o 1t e d  vi a  a  p a p er  f on n  b e c a u s e  t h e e C R F  d at a b as e  h as  b e e n  l o ck e d,  n o 
fi nth er  a cti o n i s  n e c ess a 1y. If th e  d at a b as e  i s  not l o c k e d,  a n y S A E  re p o 1t e d  vi a p a p er  m u st  b e 
tr an s cri b e d as  s o o n as  p o s si bl e  o n t h e  a p p li c a bl e e C R F s  a n d  tr a n smi tte d t o Gil e a d  P S. 
7 . 4. 2. 
7. 4. 2. 1. 
S p e ci al  S it u ati o ns R e p o rti n g  P r o c e s s 
P a p e r S p e ci al  Sit u ati o ns  R e p o 1t i ng  P r o c e s s f or St u d y  D r n g 
A ll s p e ci al sit u ati o ns  wi ll b e re c o rd e d  o n t h e S S R f on n  a n d  tr a n smi tte d b y e m ai li ng  or  f a xi ng t h e 
r ep o 1t  f on n  wit hi n 2 4 h o ur s of t h e i nv e sti g at o r' s k n o w le d g e of t h e e v e nt  t o t h e att e n ti on of 
Gi le a d  P S  fr om  stu d y  d r ng  i niti ati on t h r ou g h o ut t h e  d ur at i o n of t h e st u d y , i ncl u di ng t h e  pr ot o c ol -
r e quir e d p o stt re at m e nt  f oll o w- u p p er io d. 
P P D 
S e e  S e c tio n  7 . 4.2. 2  f or i nstr ncti o ns  o n r e p o rti ng  s p e ci al sit u ati o ns  wi t h Gi le a d  c o n c o mi t a nt 
m e di c at i o ns. 
C O N FI D E N TI A L 
P a g e  6 9 
2 4  O c to b er  2 0 2 3 

M a gr oli m a b 
Gil e a d  S ci e n c e s , I n c. 
7. 4. 2. 2. 
R e p o 1ii n g  P r o c e s s f or  Gil e a d  C o n c o mit ant  M e di c ati o n s 
Pr o to c ol  G S -U S - 5 4 8- 5 9 1 8 
A m e n d m e nt s 
S p e ci a l  sit uati o ns t h at  i nv ol v e  c o n c o mit ant  m e di c ati o n s  m a n uf a ct ur e d  b y  Gil e a d  th at  ar e  n ot 
c o n s i de r e d st u d y di u g s  m u st  b e  re p o1ie d wit hi n 2 4 h o ur s of t h e i nv e st ig at or' s  k n o wl e d g e  of  t h e 
e v e nt  t o Gil e a d  P S  utili z i ng  t h e p a p er  S S R  f o1 m  t o: 
Gil e a d: 
P P D 
A n y  i n a p pr o pri at e u s e of c o n c o mit ant m e di c ati o n s pr o hi bit e d b y  t hi s pr ot o c ol  s h oul d  n ot  b e 
r e p o 1i e d as  " mi s u s e, "  b ut  m a y  b e  m or e  a p pr o p riat e l y d o c u m e nt e d  as  a  pr ot o c ol  d e vi ati o n. 
S p e ci a l  sit uati o ns  i nv ol v i ng  n o n- Gil e a d c o n c o mit ant  m e di c ati o n s  d o  n ot  n e e d  t o b e  r ep o 1i e d  o n 
t h e S S R  f o 1 m;  ho w e v er , s p e ci al  sit uati o ns t h at res ult i n A E s  d u e  t o a  n o n- Gil e a d  c o n c o mit a nt 
m e di c ati o n m u st b e  r e p o 1i e d as a n A E. 
7. 4. 2. 3. 
Pr e g n a n c y  R e p o 1ii n g  Pr o c e s s 
T h e  i n v esti g at or w ill r e p o 1i pr e g n a n ci e s i n f em al e  st u d y p at i ent s  w h o  ar e i de ntifi e d  aft er 
i niti atio n of st u d y di u g  a n d t hr o u g h o ut th e  st u d y , i ncl u di ng t h e  pr ot o c ol -re quir e d  p o stt re at m e nt 
f oll o w- u p p eri o d  or  6  m o nt h s  aft er th e  last  d os e of l at e st a di ni n ist er e d st u d y tr e at m en t, 
w h i ch e v er  i s l o ng e r, t o Gil e a d  P S  wit hi n 2 4 h o ur s of b e c o mi n g  a w a r e of t h e pr e g n a n c y  us i ng  t h e 
pr e g n a n c y  r e p o 1i f on n.  C a nt a .ct d et ail s  f or tr a ns mitti n g  t h e pr e g n a n c y  r e p o 1i f o1 m  ar e  as  f oll o ws: 
Gil e a d 
P P D 
T h e  pr e g n a n c y  its elf is n ot  c o n s i de r e d a n A E ,  n or is a n  i n d u c e d el e cti v e  a b o 1ii o n  t o t e 1 mi n at e a 
pr e g n a n c y  wit h o ut  m e di c al  r eas o ns. 
A ll ot h er  pr e m at ur e  t e 1 mi n ati o ns of pr e g n a n c y  ( e g ,  a s p o nt a n e ou s  a b o 1ii on,  a n  i nd u c e d 
t her a p e u ti c a b orti o n  d u e  t o c o m p lic ati o ns  or  ot h er  m e di c al  re a s o n s) m u st b e  r e p o 1i e d wit hi n 
2 4 h o ur s  as  a n  S A E,  as  d e s cr i be d i n S e cti o n 7. 4 . 1. T h e  u n d e rly i ng  m e di c al  re a s o n  f or t hi s 
pr o c e d ur e  s h oul d  b e  re c or d e d  as  th e A E t e 1 m. 
A s p o nt a n e o u s a b o 1ii o n i s al w a y s  c o ns i d er e d t o b e  a n  S A E  an d w ill b e  re p o1ie d as  d e s cr i be d i n 
S e cti o n  7. 4. 1.  F mi h e 1 m o r e ,  a n y S A E  o c c u ni n g  as  a n  a d v ers e  pr e g n a n c y  o u t c o m e aft er  t h e st u d y 
m u st b e r ep o 1i e d  t o t h e Gil e a d  P S. 
C O N FI D E N TI A L 
P a g e  7 0 
2 4  O c to b er  2 0 2 3 

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 7 1
2 4 Oct o ber 2 0 2 3
T he patie nt will recei ve a p pr o priate m o nit ori n g a n d care u ntil t he c o ncl usi o n of t he pre g na nc y. 
T he o utc o me of t he pre g na nc y s h o ul d be re p orte d t o Gilea d P S usi n g t he pre g na nc y o utc o me 
re p ort f or m. If t he e n d of t he pre g na nc y occ urs after t he st u d y has bee n c o m plete d, t he o utc o me 
s h o ul d be re p orte d directl y t o Gilea d P S. Gilea d P S c o ntact i nf or mati o n is as f oll o ws: e mail: 
Refer t o A p pe n di x 6  f or Pre g na nc y Preca uti o ns, Defi niti o n f or Fe male of C hil d beari n g P ote ntial, 
a n d C o ntrace pti ve Re q uire me nts.
7. 5.   
Gile a d Re p orti n g Re q uire me nts
De pe n di n g o n rele va nt l ocal le gislati o n or re g ulati o ns, i ncl u di n g t he a p plica ble U S F D A C o de of 
Fe deral Re g ulati o ns, t he E U Cli nical Trials Directi ve ( 2 0 0 1/ 2 0/ E C) a n d rele va nt u p dates, a n d 
ot her c o u ntr y-s pecific le gislati o n or re g ulati o ns, Gilea d ma y be re q uire d t o e x pe dite t o 
w orl d wi de re g ulat or y a ge ncies re p orts of S A Es t hat ma y be i n t he f or m of li ne listi n gs, seri o us 
a d verse dr u g reacti o ns, or s us pecte d u ne x pecte d seri o us a d verse reacti o ns ( S U S A Rs). I n 
acc or da nce wit h t he E U Cli nical Trials Directi ve ( 2 0 0 1/ 2 0/ E C), Gilea d or a s pecifie d desi g nee 
will n otif y w orl d wi de re g ulat or y a ge ncies a n d t he rele va nt I E C i n c o ncer ne d Me m ber States of 
a p plica ble S U S A Rs as o utli ne d i n c urre nt re g ulati o ns.
Assess me nt of e x pecte d ness f or S A Es will be deter mi ne d b y Gilea d usi n g refere nce safet y 
i nf or mati o n s pecifie d i n t he I B or rele va nt l ocal la bel as a p plica ble.
All i n vesti gat ors will recei ve a safet y letter n otif yi n g t he m of rele va nt S U S A R re p orts ass ociate d 
wit h a n y st u d y dr u g. T he i n vesti gat or s h o ul d n otif y t he I R B or I E C of S U S A R re p orts as s o o n as 
is practical, w here t his is re q uire d b y l ocal re g ulat or y a ge ncies, a n d i n acc or da nce wit h t he l ocal 
i nstit uti o nal p olic y.
7. 6.   
Cli nic al L a b or at or y A b n or m alities a n d Ot her A b n or m al Assess me nts as 
A d verse E ve nts or Seri o us A d verse E ve nts
La b orat or y a b n or malities wit h o ut cli nical si g nifica nce are n ot t o be rec or de d as A Es or S A Es. 
H o we ver, la b orat or y a b n or malities (e g, cli nical c he mistr y, he mat ol o g y, uri nal ysis) t hat re q uire 
me dical or s ur gical i nter ve nti o n or lea d t o st u d y dr u g i nterr u pti o n, m o dificati o n, or 
disc o nti n uati o n m ust be rec or de d as a n A E, as well as a n S A E, if a p plica ble. I n a d diti o n, 
la b orat or y or ot her a b n or mal assess me nts (e g, E C G, x-ra ys, vital si g ns) t hat are ass ociate d wit h 
si g ns a n d/ or s y m pt o ms m ust be rec or de d as a n A E or S A E if t he y meet t he defi niti o n of a n A E 
or S A E as descri be d i n Secti o ns 7. 1. 1  a n d 7. 1. 2 . If t he la b orat or y a b n or malit y is part of a 
s y n dr o me, rec or d t he s y n dr o me or dia g n osis (e g, a ne mia), n ot t he la b orat or y res ult (e g, 
decrease d he m o gl o bi n).
Se verit y s h o ul d be rec or de d a n d gra de d acc or di n g t o t he N CI C T C A E, Versi o n 5. 0. F or A Es 
ass ociate d wit h la b orat or y a b n or malities, t he e ve nt s h o ul d be gra de d o n t he basis of t he cli nical 
se verit y i n t he c o nte xt of t he u n derl yi n g c o n diti o ns; t his ma y or ma y n ot be i n a gree me nt wit h 
t he gra di n g of t he la b orat or y a b n or malit y.
P P D

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 7 2
2 4 Oct o ber 2 0 2 3
7. 7.   
A b n or m al Li ver F u ncti o n Tests
Li ver t o xicit y will be e val uate d f or all patie nts.
I n t he a bse nce of a n e x pla nati o n f or i ncrease d li ver f u ncti o n tests, s uc h as viral he patitis, 
pre-e xisti n g or ac ute li ver disease, or e x p os ure t o ot her a ge nts ass ociate d wit h li ver i nj ur y, t he 
patie nt ma y be disc o nti n ue d fr o m t he st u d y treat me nt if t he i n vesti gat or deter mi nes t hat it is n ot 
i n t he patie nt’s best i nterest t o c o nti n ue. Disc o nti n uati o n of treat me nt s h o ul d be c o nsi dere d if 
t here is a n i n dicati o n of se vere li ver i nj ur y acc or di n g t o H y’s La w, defi ne d b y F D A G ui da nce f or 
I n d ustr y, Dr u g-I n d uce d Li ver I nj ur y: Pre mar keti n g Cli nical E val uati o n {U. S. De part me nt of 
Healt h a n d H u ma n Ser vices 2 0 0 9 }, as:
•
Treat me nt-e mer ge nt A L T or A S T ele vati o n ( ≥ 3  U L N), A N D
•
Treat me nt-e mer ge nt t otal bilir u bi n ele vati o n ( > 2  U L N), a n d a bse nce of c h olestasis 
( defi ne d as al kali ne p h os p hatase < 2  U L N), A N D
•
N o ot her g o o d e x pla nati o n f or t he i nj ur y ( he patitis A, B, C, or ot her viral he patic i nj ur y, 
alc o h ol i n gesti o n, c o n gesti ve heart fail ure, w orse ni n g li ver metastases).
7. 8.  
T o xicit y M a n a ge me nt
7. 8. 1.   
M a gr oli m a b
7. 8. 1. 1.  
T y pe a n d Scree n a n d Direct A nti gl o b uli n Test
Ma gr oli ma b ma y i nterfere wit h R B C p he n ot y pi n g d ue t o e x pecte d c oati n g of t he R B C 
me m bra ne. D ue t o t he ris k of de vel o pi n g a ne mia, a n d beca use ma gr oli ma b ma y ma ke 
p he n ot y pi n g diffic ult, A B O/ R h t y pe, a nti b o d y scree n, e xte n de d R B C p he n ot y pi n g or ge n ot y pi n g, 
a n d direct a nti gl o b uli n test ( D A T) nee d t o be perf or me d at scree ni n g bef ore e x p os ure t o 
ma gr oli ma b, as descri be d i n Secti o n 7. 8. 1. 1. 1 . 
Re d bl o o d cell p he n ot y pi n g/ ge n ot y pi n g, A B O t y pe, a n d D A T nee d n ot be re peate d if res ults 
date d bef ore scree ni n g are a vaila ble. A nti b o d y scree n nee d n ot be re peate d if res ults date d bef ore 
scree ni n g are a vaila ble, u nless t he patie nt was tra nsf use d si nce t hat ti me. 
7. 8. 1. 1. 1.   
A ne mia, Bl o o d Cr oss- matc hi n g, a n d Pac ke d Re d Bl o o d Cell Tra nsf usi o n 
Pr oce d ures
Ma gr oli ma b bi n ds t o R B Cs a n d lea ds t o er yt hr o p ha g oc yt osis. C D 4 7 is a me m ber of t he R h 
c o m ple x i n t he R B C’s me m bra ne. T heref ore, w he n ma gr oli ma b bi n ds t o C D 4 7, it is li kel y t o 
i nterfere wit h r o uti ne bl o o d ba n k tests nee de d i n case of tra nsf usi o n. N otif y bl o o d tra nsf usi o n 
ce nters/ bl o o d ba n ks of t his i nterfere nce wit h bl o o d ba n k testi n g a n d i nf or m t he m t hat a patie nt 
will recei ve ma gr oli ma b.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 7 3
2 4 Oct o ber 2 0 2 3
I n cli nical st u dies, a ne mia is t he m ost c o m m o n treat me nt-relate d A E a n d is t y picall y ma nifeste d 
as a decli ne i n he m o gl o bi n of a b o ut 0. 5 g/ d L t o 1. 5 g/ d L o bser ve d i n t he first 1 t o 2 wee ks of 
treat me nt. T his decrease i n he m o gl o bi n le vel has bee n acce pta ble i n patie nts wit h n o ot her 
si g nifica nt diseases or me dical c o n diti o ns. H o we ver, f or patie nts wit h si g nifica nt diseases or 
me dical c o n diti o ns, s uc h as u nsta ble a n gi na, isc he mic heart disease, or u nc o ntr olle d dia betes 
mellit us, treat me nt ‑relate d a ne mia c o ul d be life‑t hreate ni n g or fatal. Si g nifica nt dr o ps i n 
he m o gl o bi n le vel ( 2 g/ d L or hi g her) ha ve als o bee n o bser ve d i n earl y d oses.
Patie nts wit h a l o w baseli ne he m o gl o bi n le vel, es peciall y t h ose wit h car diac hist or y or ris k 
fact ors, m ust be m o nit ore d cl osel y after i nitial a d mi nistrati o ns of ma gr oli ma b as pree xisti n g 
a ne mia c o ul d be e xacer bate d. Re d bl o o d cell tra nsf usi o ns are per mitte d pri or t o st u d y treat me nt 
t o e ns ure a de q uate he m o gl o bi n le vel as per i n vesti gat or cli nical j u d g me nt. 
Wit hi n 2 4 h o urs pri or t o eac h of t he first 2 d oses of ma gr oli ma b i nf usi o n d uri n g i nitial treat me nt, 
all patie nts m ust ha ve a d oc u me nte d he m o gl o bi n ≥ 9 g/ d L. Patie nts w h o d o n ot meet t hese 
criteria m ust be tra nsf use d a n d ha ve t heir he m o gl o bi n rec hec ke d t o meet 9 g/ d L pri or t o eac h of 
t he first 2 d oses of ma gr oli ma b. He m o gl o bi n s h o ul d be m o nit ore d fre q ue ntl y f or res p o nse a n d/ or 
t o xicit y pri or t o eac h d ose a n d 3 t o 6 h o urs after t he i nitiati o n of t he first a n d sec o n d d oses of 
ma gr oli ma b. Bl o o d tra nsf usi o ns s h o ul d be c o nsi dere d as cli nicall y a p pr o priate. C o nsi der 
a d diti o nal he m o gl o bi n m o nit ori n g d uri n g t he first wee k of ma gr oli ma b treat me nt i n patie nts wit h 
s y m pt o ms of a ne mia or at i ncrease d ris k f or c o m plicati o ns of a ne mia.
Pri or t o i nitiati o n of ma gr oli ma b, A B O/ R h t y pe a n d scree n, D A T, a n d e xte n de d R B C 
p he n ot y pi n g (i ncl u di n g mi n or a nti ge ns s uc h as R h, Cc Ee, C w, M N Ss, K k, F ya, F y b, J ka, a n d 
J k b) are t o be perf or me d f or eac h patie nt. Re d bl o o d cell ge n ot y pi n g i nstea d of e xte n de d R B C 
p he n ot y pi n g is acce pta ble f or a n y patie nt. Re d bl o o d cell ge n ot y pi n g (i nstea d of a n e xte n de d 
R B C p he n ot y pe) m ust be perf or me d if a patie nt recei ve d a n y R B C or w h ole bl o o d tra nsf usi o n 
wit hi n t he pre vi o us 3 m o nt hs ( u nless la b orat or y has a vaila bilit y f or s pecial tec h ni q ues f or 
perf or mi n g p he n ot y pi n g f or patie nts wit h rece nt tra nsf usi o n). Res ults m ust be a vaila ble bef ore 
t he first d ose of ma gr oli ma b. 
7. 8. 1. 1. 2.  
F or Patie nts After E x p os ure t o Ma gr oli ma b
A n a d diti o nal he m o gl o bi n m ust be c hec ke d 3 t o 6 h o urs after t he i nitiati o n of t he first a n d sec o n d 
d oses of ma gr oli ma b d uri n g i nitial treat me nt. T he patie nt s h o ul d be tra nsf use d as cli nicall y 
a p pr o priate. I n vesti gat ors s h o ul d c o nsi der a d diti o nal he m o gl o bi n m o nit ori n g d uri n g t he first 
wee k of treat me nt i n patie nts wit h s y m pt o ms of a ne mia or at i ncrease d ris k f or c o m plicati o ns of 
a ne mia.
F or all electi ve R B C a n d platelet tra nsf usi o ns, use le u k oc yte-re d uce d a n d ga m ma-irra diate d u nits 
per i nstit uti o nal g ui deli nes. F or R B C tra nsf usi o ns, p he n ot y pe/ ge n ot y pe- matc he d u nits are 
preferre d. H o we ver, C M V-ser o ne gati ve u nits f or C M V-ser o ne gati ve patie nts will n ot be re q uire d 
f or t his st u d y.
I n case A B O/ R h t y pe ca n n ot be res ol ve d, use pretreat me nt p he n ot y pe/ ge n ot y pe- matc he d u nits 
f or mi n or R B C a nti ge ns ( Cc Ee a n d K k, t o t he feasi ble e xte nt). Re gar di n g t he A B O t y pe, t he 
i nstit uti o n ca n use hist orical bl o o d gr o u p or O t y pe as per t he i nstit uti o nal g ui deli nes. 

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 7 4
2 4 Oct o ber 2 0 2 3
F or e mer ge nc y tra nsf usi o ns, t he tra nsf usi o n ce nters ma y c o nsi der usi n g e mer ge nc y Gr o u p O re d 
cells if p he n ot y pe/ ge n ot y pe- matc he d u nits are n ot a vaila ble.
W he ne ver p ossi ble, bl o o d plas ma t hera p y s h o ul d be bl o o d t y pe s pecific. Platelets s h o ul d be 
bl o o d t y pe c o m pati ble w he ne ver p ossi ble a n d, if n ot, s h o ul d ha ve bee n teste d a n d f o u n d n ot t o 
ha ve hi g h titer a nti- A or a nti- B. Ot her wise, plas ma a n d platelet pr o d ucts ca n be pr o vi de d as per 
t he i nstit uti o nal p olic y.
A rece nt re p ort has s u g geste d t hat cr oss- matc h i nterfere nce b y R B Cs d ue t o treat me nt wit h 
ma gr oli ma b ma y be res ol ve d b y use of ga m ma-cl o ne a nti-I g G a n d m ulti ple all oa ds or pti o ns wit h 
pa pai n-treate d R B C sa m ples, p o ole d si n gle d o n or a p heresis platelets, or c o m mercial h u ma n 
platelet c o nce ntrate pr o d uct if re q uire d { Tr o u g ht o n 2 0 1 8 , Velli q uette 2 0 1 9 }.
7. 8. 1. 2.   
Ma na ge me nt of I nf usi o n-relate d Reacti o ns
I nf usi o n-relate d reacti o ns are defi ne d b y t he N CI C T C A E, Versi o n 5. 0 as “a dis or der 
c haracterize d b y a d verse reacti o n t o t he i nf usi o n of p har mac ol o gical or bi ol o gical s u bsta nces” 
(A p pe n di x 5 ). F or t he p ur p oses of t his st u d y, t he ti me fra me f or I R R assess me nt is t he 2 4- h o ur 
peri o d be gi n ni n g fr o m t he start of t he i nf usi o n. Pre me dicati o n use descri be d i n Secti o n 5. 6  will 
be use d t o ma na ge I R Rs pree m pti vel y.
Rec o m me n dati o ns f or t he ma na ge me nt of I R Rs relate d t o ma gr oli ma b are pr o vi de d i n Ta ble 1 1 .
T a ble 1 1.
M a n a ge me nt of I nf usi o n-rel ate d Re acti o ns
I nf usi o n- Rel ate d Re acti o ns
C T C A E Gr a de 
M a n a ge me nt
Gr a de 1
Mil d tra nsie nt reacti o n.
Re mai n at be dsi de a n d m o nit or patie nt u ntil rec o ver y fr o m s y m pt o ms.
Patie nts w h o e x perie nce I R Rs wit h t he first 2 d oses of ma gr oli ma b s h o ul d 
c o nti n ue pre me dicati o n wit h c ortic oster oi ds pri or t o s u bse q ue nt d oses at t he 
i n vesti gat or’s discreti o n.
Gr a de 2
Re q uiri n g s y m pt o matic treat me nt 
a n d pr o p h ylactic me dicati o ns f or 
≤ 2 4 h o urs.
I nterr u pt ma gr oli ma b t hera p y per pr ot oc ol a n d be gi n a n I V i nf usi o n of 
n or mal sali ne a n d c o nsi der treati n g t he patie nt wit h di p he n h y dra mi ne 5 0 m g 
I V ( or e q ui vale nt) a n d/ or 5 0 0 t o 7 5 0 m g of oral aceta mi n o p he n.
Re mai n at be dsi de a n d m o nit or patie nt u ntil res ol uti o n of s y m pt o ms.
C ortic oster oi d t hera p y ma y als o be gi ve n at t he discreti o n of t he i n vesti gat or.
If t he i nf usi o n is i nterr u pte d, wait u ntil s y m pt o ms res ol ve, t he n restart t he 
i nf usi o n at 5 0 % of t he ori gi nal i nf usi o n rate.
If n o f urt her c o m plicati o ns occ ur after 1 h o ur ( ± 1 0 mi n utes), t he rate ma y be 
i ncrease d t o 1 0 0 % of t he ori gi nal i nf usi o n rate. M o nit or t he patie nt cl osel y.
If s y m pt o ms rec ur, st o p i nf usi o n a n d disc o n nect patie nt fr o m t he i nf usi o n 
a p parat us. N o f urt her ma gr oli ma b will be a d mi nistere d at t hat visit.
Patie nts w h o e x perie nce I R Rs wit h t he first 2 d oses of ma gr oli ma b s h o ul d 
c o nti n ue pre me dicati o n wit h c ortic oster oi ds pri or t o s u bse q ue nt d oses at t he 
i n vesti gat or’s discreti o n.
T he a m o u nt of ma gr oli ma b i nf use d m ust be rec or de d o n t he e C R F.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 7 5
2 4 Oct o ber 2 0 2 3
I nf usi o n- Rel ate d Re acti o ns
C T C A E Gr a de 
M a n a ge me nt
Patie nts w h o e x perie nce a Gra de 2 i nf usi o n-relate d reacti o n d uri n g t he 
p osti nf usi o n o bser vati o n peri o d t hat d oes n ot res ol ve t o ≤ Gra de 1 d uri n g t hat 
ti me s h o ul d be o bser ve d u ntil t he A E res ol ves or sta bilizes, wit h vital si g n 
meas ure me nts as me dicall y i n dicate d f or t he ma na ge me nt of t he A E.
Gr a de 3- 4
Gra de 3: Pr ol o n ge d reacti o ns or 
rec urre nce of s y m pt o ms 
f oll o wi n g i nitial i m pr o ve me nt, or 
w here h os pitalizati o n is i n dicate d 
f or ot her cli nical se q uelae.
Gra de 4: Life-t hreate ni n g 
c o nse q ue nces, w here ur ge nt 
i nter ve nti o n is i n dicate d.
I m me diatel y disc o nti n ue i nf usi o n of ma gr oli ma b.
Be gi n a n I V i nf usi o n of n or mal sali ne a n d c o nsi der treati n g t he patie nt as 
f oll o ws: A d mi nister br o nc h o dilat ors, e pi ne p hri ne 0. 2 t o 1 m g of a 
1: 1 0 0 0 s ol uti o n f or S C a d mi nistrati o n or 0. 1 t o 0. 2 5 m g of a 
1: 1 0, 0 0 0 s ol uti o n i njecte d sl o wl y f or I V a d mi nistrati o n a n d/ or 
di p he n h y dra mi ne 5 0 m g I V wit h met h yl pre d nis ol o ne 1 0 0 m g I V ( or 
e q ui vale nt), as nee de d.
T he patie nt s h o ul d be m o nit ore d u ntil t he i n vesti gat or is c o mf orta ble t hat t he 
s y m pt o ms will n ot rec ur.
Patie nts w h o e x perie nce Gra de 3 I R Rs m ust be gi ve n pre me dicati o n pri or t o 
s u bse q ue nt d oses. I n t his setti n g, pre me dicati o n wit h oral aceta mi n o p he n 
( 6 5 0 t o 1 0 0 0 m g), oral or I V di p he n h y dra mi ne ( 2 5 t o 5 0 m g), a n d I V 
de xa met has o ne ( 4 t o 2 0 m g), or a c o m para ble re gi me n, is rec o m me n de d f or 
t he s u bse q ue nt 2 d oses. C o nti n ue d pre me dicati o n wit h c ortic oster oi ds 
be y o n d t hese 2 d oses ma y be a d mi nistere d at t he discreti o n of t he treati n g 
p h ysicia n. 
Patie nts w h o recei ve pre me dicati o n a n d still e x perie nce a rec urre nt Gra de 3 
I R R or patie nts w h o e x perie nce a Gra de 4 I R R at a n y ti me s h o ul d be 
per ma ne ntl y disc o nti n ue d fr o m t he st u d y treat me nt.
F or a na p h yla xis, i n vesti gat ors s h o ul d f oll o w t heir i nstit uti o nal g ui deli nes f or 
treat me nt.
All patie nts wit h ≥ Gra de 3 I R Rs will be o bser ve d u ntil t he A E res ol ves or 
sta bilizes, wit h vital si g n meas ure me nts a n d a d diti o nal e val uati o ns as 
me dicall y i n dicate d f or t he ma na ge me nt of t he A Es.
A E = a d verse e ve nt; C T C A E = C o m m o n Ter mi n ol o g y Criteria f or A d verse E ve nts; e C R F = electr o nic case re p ort f or m; 
I R R = i nf usi o n-relate d reacti o n; I V = i ntra ve n o us; S C = s u bc uta ne o us
7. 8. 1. 3.   
Ma na ge me nt of P ne u m o nitis
P ne u m o nitis has bee n i nfre q ue ntl y o bser ve d i n patie nts recei vi n g ma gr oli ma b. Ge nerall y, 
i m m u ne-relate d A Es ha ve n ot bee n o bser ve d i n cli nical use wit h ma gr oli ma b. I n c o ntrast t o 
T-cell c hec k p oi nt i n hi bit ors, ma gr oli ma b pri maril y e xerts its a ntit u m or efficac y t hr o u g h 
macr o p ha ge- me diate d p ha g oc yt osis of t u m or cells. N o ns pecific T-cell or ot her h ost i m m u ne 
res p o nses t hat are see n wit h T-cell c hec k p oi nt i n hi bit ors ha ve n ot bee n o bser ve d wit h 
ma gr oli ma b i n n o ncli nical st u dies. A d diti o nall y, n o e ve nts of macr o p ha ge acti vati o n s y n dr o me 
or he m o p ha g oc ytic l y m p h o histi oc yt osis ha ve bee n re p orte d i n cli nical st u dies.
I n i nsta nces of s us pecte d p ne u m o nitis, first r ule o ut n o ni nfla m mat or y ca uses (e g, i nfecti o ns). If a 
n o ni nfla m mat or y ca use is i de ntifie d, treat acc or di n gl y a n d c o nti n ue t hera p y per pr ot oc ol. 
E val uate wit h i ma gi n g (e g, c hest x-ra y or C T) a n d p ul m o nar y c o ns ultati o n.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 7 6
2 4 Oct o ber 2 0 2 3
Ma na ge me nt of p ote ntial p ne u m o nitis is detaile d i n Ta ble 1 2  a n d f oll o ws A merica n S ociet y of 
Cli nical O nc ol o g y ( A S C O) g ui deli nes f or i m m u ne-relate d A Es { Bra h mer 2 0 1 8 }. Patie nts w h o 
e x perie nce Gra de 3 or 4 p ne u m o nitis will be per ma ne ntl y disc o nti n ue d fr o m st u d y treat me nt.
T a ble 1 2.
P ne u m o nitis M a n a ge me nt Al g orit h m
C T C A E Gr a de of 
P ne u m o nitis
M a n a ge me nt
F oll o w- U p
Gr a de 1
Ra di o gra p hic c ha n ges 
( C X R or C T) o nl y.
M o nit or f or si g ns a n d s y m pt o ms wee kl y a n d 
c o nsi der m o nit ori n g wit h C X R.
C o nsi der p ul m o nar y a n d i nfecti o us disease 
c o ns ults.
C o nsi der re-i ma gi n g wit h C T i n 
3- 4 wee ks as cli nicall y i n dicate d.
Ma y res u me ma gr oli ma b wit h 
ra di o gra p hic e vi de nce of 
i m pr o ve me nt or res ol uti o n.
If n o cli nical i m pr o ve me nt or 
w orse ni n g, treat as Gra de 2.
Gr a de 2
Mil d t o m o derate ne w 
s y m pt o ms.
I nterr u pt ma gr oli ma b t hera p y per pr ot oc ol.
P ul m o nar y a n d i nfecti o us disease c o ns ults.
C o nsi der e m pirical a nti bi otics.
M o nit or si g ns a n d s y m pt o ms e ver y 2- 3 da ys; 
c o nsi der h os pitalizati o n.
1 m g/ k g/ da y oral pre d nis o ne or I V e q ui vale nt.
C o nsi der br o nc h osc o p y, l u n g bi o ps y.
Re-i ma ge e ver y 1- 3 da ys.
If i m pr o vi n g t o baseli ne, ta per 
c ortic oster oi ds o ver 4- 6 wee ks 
a n d res u me ma gr oli ma b t hera p y 
per pr ot oc ol.
If n o cli nical i m pr o ve me nt after 
4 8- 7 2 h o urs or w orse ni n g, treat 
as Gra de 3- 4.
Gr a de 3- 4
Se vere ne w s y m pt o ms; 
ne w/ w orse ni n g h y p o xia; 
life-t hreate ni n g.
Disc o nti n ue ma gr oli ma b t hera p y.
H os pitalize.
P ul m o nar y a n d i nfecti o us disease c o ns ults.
1- 2 m g/ k g/ da y met h yl pre d nis ol o ne I V or I V 
e q ui vale nt.
A d d e m pirical a nti bi otics a n d c o nsi der 
pr o p h ylactic a nti bi otics f or o p p ort u nistic 
i nfecti o ns.
C o nsi der br o nc h osc o p y, l u n g bi o ps y.
If i m pr o vi n g t o baseli ne, ta per 
c ortic oster oi ds o ver 4- 6 wee ks.
If n o cli nical i m pr o ve me nt after 
4 8 h o urs or w orse ni n g, c o nsi der 
a d diti o nal i m m u n os u p pressi o n 
(e g, i nfli xi ma b, 
c ycl o p h os p ha mi de, I V 
i m m u n o gl o b uli n, m yc o p he n olate 
m ofetil).
C T = c o m p ute d t o m o gra p h y; C T C A E = C o m m o n Ter mi n ol o g y Criteria f or A d verse E ve nts; C X R = c hest x-ra y; 
I V = i ntra ve n o us
7. 8. 1. 4.  
T hr o m b oe m b olic E ve nts
T hr o m b oe m b olic e ve nts, i ncl u di n g dee p vei n t hr o m b oses a n d p ul m o nar y e m b olis ms, ha ve bee n 
re p orte d i n s o me patie nts recei vi n g ma gr oli ma b, s o meti mes earl y i n t hera p y. A vaila ble data f or 
ma gr oli ma b d o n ot s u p p ort a clear or c o nsiste nt relati o ns hi p bet wee n cli nical t hr o m b oe m b olic 
e ve nts a n d ma gr oli ma b use. Patie nts s h o ul d be cl osel y m o nit ore d f or t he s y m pt o ms of 
t hr o m b oe m b olic e ve nts a n d treate d acc or di n gl y.
7. 8. 1. 5.  
Se vere Ne utr o pe nia
Se vere ne utr o pe nia a n d fe brile ne utr o pe nia ha ve bee n re p orte d i n patie nts treate d wit h 
ma gr oli ma b. Cl ose m o nit ori n g of he mat ol o gic para meters ( A p pe n di x Ta ble 1  a n d 
A p pe n di x Ta ble 2 ) i ncl u di n g ne utr o p hils is re q uire d f or all patie nts treate d wit h ma gr oli ma b. 

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 7 7
2 4 Oct o ber 2 0 2 3
Pr o p h ylactic a nti bi otics a n d/ or a nti m yc otics s h o ul d be c o nsi dere d. A d mi nister 
gra n ul oc yte-c ol o n y sti m ulati n g fact or if cli nicall y i n dicate d.
Rec o m me n dati o ns f or ma gr oli ma b d ose dela y i n case of se vere ne utr o pe nia: 
•
F or Gra de 3 ne utr o pe nia wit h o ut fe ver or i nfecti o n, dela y of ma gr oli ma b d osi n g is n ot 
rec o m me n de d.
•
F or Gra de 4 ne utr o pe nia ( A N C < 5 0 0/ μ L) wit h o ut fe ver or i nfecti o n, or Gra de 3 or hi g her 
ne utr o pe nia wit h fe ver or i nfecti o n, ma gr oli ma b d ose dela y s h o ul d be c o nsi dere d. U p o n 
res ol uti o n t o Gra de ≤ 2, res u mi n g ma gr oli ma b at t he sa me d ose s h o ul d be c o nsi dere d.
•
F or persiste nt se vere ne utr o pe nia or fe brile ne utr o pe nia ( > 2 occ urre nces), disc o nti n uati o n of 
ma gr oli ma b ca n be c o nsi dere d.
7. 8. 1. 6.  
Seri o us I nfecti o ns
Patie nts ( wit h or wit h o ut ne utr o pe nia) s h o ul d be re g ularl y m o nit ore d f or si g ns a n d s y m pt o ms of 
i nfecti o n. F or patie nts wit h pr ol o n ge d ne utr o pe nia or patie nts at ris k, c o nsi der i nfecti o n 
pr o p h yla xis i ncl u di n g a nti bi otics (e g, fl u or o q ui n ol o ne) or a ntif u n gal a ge nts (e g, oral triaz oles or 
pare nteral ec hi n oca n di n) i n acc or da nce wit h c urre nt g ui deli nes.
F or seri o us i nfecti o ns, h ol d ma gr oli ma b u ntil t he i nfecti o n has res ol ve d cli nicall y. F or seri o us 
i nfecti o ns t hat re mai n acti ve f or ≥ 1 4 da ys, c o nsi der disc o nti n uati o n of ma gr oli ma b.
7. 8. 2.   
D ocet a xel
Safet y ma na ge me nt g ui deli nes f or d oceta xel are descri be d i n Secti o n 5. 3. 3 . A d diti o nal safet y 
g ui deli nes are pr o vi de d i n t he d oceta xel prescri bi n g i nf or mati o n. D oceta xel prescri bi n g 
i nf or mati o n pr o vi des g ui da nce o n a d mi nistrati o n, c o ntrai n dicati o ns, s pecial war ni n gs a n d 
preca uti o ns, as well as i nteracti o n wit h ot her me dici nal pr o d ucts.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 7 8
2 4 Oct o ber 2 0 2 3
8.  
S T A TI S TI C A L C O N SI D E R A TI O N S
T his secti o n pr o vi des a hi g h-le vel descri pti o n of t he pla n ne d a nal yses a n d assesse d sa m ple sizes 
wit h ass u m pti o ns. A d diti o nal details of t he statistical met h o ds will be pr o vi de d i n t he statistical 
a nal ysis pla n, i ncl u di n g a n y de viati o ns fr o m t he ori gi nal statistical a nal yses pla n ne d. 
8. 1.   
A n al ysis O bjecti ves a n d E n d p oi nts
T he o bjecti ves a n d e n d p oi nts are pr o vi de d i n Secti o n 2 .
8. 2.  
Pl a n ne d A n al yses
8. 2. 1.   
D ose Deter mi n ati o n A n al ysis
F or t he p ur p oses of ma ki n g t he d ose de-escalati o n decisi o ns f or Safet y R u n-i n C o h ort 1, d ose 
deter mi nati o n a nal yses of rele va nt safet y data f oc usi n g o n D L Ts a n d o verall safet y pr ofile will 
be c o n d ucte d b y t he s p o ns or after all patie nts ha ve c o m plete d re q uire d d osi n g c ycles ( 2 1 da ys) 
a n d t he f oll o w- u p peri o d as defi ne d i n Secti o n 3. 1. 1 . Safet y assess me nts (e g, A Es, E C G, 
la b orat or y res ults) will be dis pla ye d b y c o h ort t o facilitate d ose de-escalati o n decisi o ns.
8. 2. 2.  
Pri m ar y A n al ysis
F or eac h of t he s u bc o h orts i n P hase 2 C o h ort 1, t he pri mar y a nal ysis of O R R will be c o n d ucte d 
at least a p pr o xi matel y 6 m o nt hs after t he last patie nt is e nr olle d, o utsta n di n g data q ueries ha ve 
bee n res ol ve d or a dj u dicate d as u nres ol va ble, a n d t he data ha ve bee n clea ne d a n d fi nalize d f or 
t he a nal ysis.
8. 2. 3.  
Fi n al A n al ysis
A fi nal a nal ysis ma y be perf or me d after all patie nts ha ve c o m plete d t he st u d y or disc o nti n ue d 
earl y, o utsta n di n g data q ueries ha ve bee n res ol ve d or a dj u dicate d as u nres ol va ble, a n d t he data 
ha ve bee n clea ne d a n d fi nalize d.
8. 3.   
A n al ysis C o n ve nti o ns
8. 3. 1.   
A n al ysis Sets
8. 3. 1. 1.   
M o difie d I T T A nal ysis Set
T he m o difie d I T T A nal ysis Set i ncl u des all e nr olle d patie nts w h o t o o k at least 1 d ose of a n y 
st u d y dr u g. T his is t he pri mar y a nal ysis set f or efficac y a nal yses of P hase 2 C o h orts 1a, 1 b, 
a n d 1c.
8. 3. 1. 2.  
Safet y A nal ysis Set
T he Safet y A nal ysis Set i ncl u des all patie nts w h o t o o k at least 1 d ose of a n y st u d y dr u g. T his is 
t he pri mar y a nal ysis set f or safet y a nal yses (e xce pt f or D L Ts) of b ot h Safet y R u n-i n C o h ort 1 
a n d P hase 2 C o h orts 1a, 1 b, a n d 1c.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 7 9
2 4 Oct o ber 2 0 2 3
8. 3. 1. 3.   
D ose- Li miti n g T o xicit y E val ua ble A nal ysis Set
F or Safet y R u n-i n C o h ort 1, t he pri mar y a nal ysis set f or t he pri mar y D L T a nal ysis is t he D L T 
E val ua ble A nal ysis Set, defi ne d as all patie nts w h o meet 1 of t he f oll o wi n g criteria i n t he D L T 
e val ua ble peri o d ( defi ne d as wit hi n 2 1 da ys of t he first d osi n g c ycle):
•
T he patie nt e x perie nce d a D L T at a n y ti me after i nitiati o n of t he first i nf usi o n of ma gr oli ma b.
•
T he patie nt di d n ot e x perie nce a D L T a n d c o m plete d at least 2 i nf usi o ns of ma gr oli ma b 
( 2 1- da y c ycle) a n d at least 1 d ose of d oceta xel i n Safet y R u n-i n C o h ort 1.
8. 3. 1. 4.  
P har mac o ki netics
T he P K a nal ysis will be c o n d ucte d o n t he P K A nal ysis Set, defi ne d as all patie nts w h o recei ve d 
a n y a m o u nt of ma gr oli ma b a n d ha ve at least 1 meas ura ble p osttreat me nt ser u m c o nce ntrati o n of 
ma gr oli ma b.
8. 3. 1. 5.  
I m m u n o ge nicit y
T he i m m u n o ge nicit y a nal ysis will be c o n d ucte d o n t he I m m u n o ge nicit y A nal ysis Set, defi ne d as 
all patie nts w h o recei ve d a n y a m o u nt of ma gr oli ma b a n d ha ve at least 1 e val ua ble 
a nti- ma gr oli ma b a nti b o d y test res ult.
8. 3. 1. 6.  
Bi o mar ker
T he bi o mar ker a nal ysis will be c o n d ucte d o n t he Bi o mar ker A nal ysis Set, defi ne d as all patie nts 
w h o recei ve d a n y st u d y dr u g a n d ha ve at least 1 e val ua ble bi o mar ker meas ure me nt a vaila ble.
8. 3. 2.   
D at a H a n dli n g C o n ve nti o ns
B y- patie nt listi n gs will be create d f or i m p orta nt varia bles fr o m eac h e C R F m o d ule. S u m mar y 
ta bles f or c o nti n u o us varia bles will c o ntai n t he f oll o wi n g statistics: N ( n u m ber i n a nal ysis set), 
n ( n u m ber wit h data), mea n, S D, 9 5 % CIs o n t he mea n, me dia n, mi ni m u m, a n d ma xi m u m. 
S u m mar y ta bles f or cate g orical varia bles will i ncl u de: N, n, perce nta ge, a n d 9 5 % CIs o n t he 
perce nta ge. U nless ot her wise i n dicate d, 9 5 % CIs f or bi nar y varia bles will be calc ulate d usi n g t he 
bi n o mial distri b uti o n (e xact met h o d) a n d will be 2-si de d. Data will be descri be d a n d s u m marize d 
b y treat me nt gr o u p a n d c o h ort.
T he baseli ne val ue use d i n eac h a nal ysis will be t he last ( m ost rece nt) pretreat me nt val ue bef ore 
or o n t he first d osi n g date of st u d y treat me nt. As a p pr o priate, c ha n ges fr o m baseli ne t o eac h 
s u bse q ue nt ti me p oi nt will be descri be d a n d s u m marize d. Gra p hical tec h ni q ues (ie, waterfall 
pl ots, Ka pla n- Meier [ K M] c ur ves, li ne pl ots) ma y be use d w he n s uc h met h o ds are a p pr o priate 
a n d i nf or mati ve. A nal yses will be base d u p o n t he o bser ve d data u nless met h o ds f or ha n dli n g 
missi n g data are s pecifie d. If t here is a si g nifica nt de gree of n o n n or malit y, a nal yses ma y be 
perf or me d o n l o g-tra nsf or me d data or n o n para metric tests ma y be a p plie d, as a p pr o priate.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 8 0
2 4 Oct o ber 2 0 2 3
8. 4.   
De m o gr a p hic a n d B aseli ne C h ar acteristics A n al ysis
De m o gra p hic a n d baseli ne meas ure me nts will be s u m marize d usi n g sta n dar d descri pti ve 
met h o ds. De m o gra p hic s u m maries will i ncl u de se x, race/et h nicit y, a n d a ge. Baseli ne data will 
i ncl u de a s u m mar y of b o d y wei g ht, hei g ht, b o d y mass i n de x, selecte d la b orat or y data, me dical 
a n d ca ncer hist or y, pri or treat me nt a n d n u m ber of pri or treat me nt(s), t u m or i ma gi n g f or baseli ne 
res p o nse assess me nt, a n d E C O G perf or ma nce stat us.
8. 5.  
Effic ac y A n al ysis
8. 5. 1.  
Pri m ar y Effic ac y E n d p oi nt A n al ysis
F or P hase 2 C o h ort 1, O R R al o n g wit h t he 9 5 % CI base d o n t he Cl o p per- Pears o n met h o d will be 
esti mate d f or eac h c o h ort ( P hase 2 C o h orts 1a, 1 b, a n d 1c). Patie nts w h o d o n ot ha ve s ufficie nt 
baseli ne or o n-st u d y t u m or assess me nt t o c haracterize res p o nse will be c o u nte d as 
n o nres p o n ders.
8. 5. 2.  
Sec o n d ar y Effic ac y E n d p oi nt A n al yses
F or a nal yses of P F S, O S, a n d D O R, t he K M esti mate of t he s ur vi val f u ncti o n will be c o m p ute d, 
a n d t he res ults will be prese nte d usi n g a K M c ur ve. T he me dia n d urati o n will be pr o vi de d al o n g 
wit h c orres p o n di n g 9 5 % CIs.
8. 6.  
S afet y A n al ysis
8. 6. 1.  
Pri m ar y S afet y E n d p oi nt A n al ysis
F or Safet y R u n-i n C o h ort 1, t he i nci de nce of D L Ts d uri n g t he D L T assess me nt peri o d b y c o u nt 
a n d perce nta ge will be re p orte d f or Safet y R u n-i n C o h ort 1 usi n g t he D L T E val ua ble A nal ysis 
Set. T he D L T assess me nt peri o d is defi ne d as t he first c ycle ( 2 1 da ys).
8. 6. 2.   
Ot her S afet y A n al ysis
All safet y data c ollecte d o n or after t he date t hat st u d y dr u g was first dis pe nse d u p t o t he date of 
last d ose of st u d y dr u g + 3 0 da ys will be s u m marize d b y c o h ort ( Safet y R u n-i n C o h ort 1, P hase 2 
C o h orts 1a, 1 b, a n d 1c, res pecti vel y). Data f or t he pretreat me nt a n d treat me nt-free safet y 
f oll o w- u p peri o ds will be i ncl u de d i n data listi n gs. F or cate g orical safet y data, i ncl u di n g 
i nci de nce of A Es a n d cate g orizati o ns of la b orat or y data, c o u nts a n d perce nta ges of patie nts will 
be s u m marize d. F or c o nti n u o us safet y data, i ncl u di n g la b orat or y data, n u m ber of patie nts, mea n, 
S D, mi ni m u m, q uartiles, me dia n, a n d ma xi m u m will be s u m marize d.
8. 6. 3.  
E xte nt of E x p os ure
A patie nt’s e xte nt of e x p os ure t o st u d y dr u gs data will be ge nerate d fr o m t he st u d y dr u g 
a d mi nistrati o n data. E x p os ure data will be s u m marize d b y c o h ort ( Safet y R u n-i n C o h ort 1, 
P hase 2 C o h orts 1a, 1 b, a n d 1c, res pecti vel y).

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 8 1
2 4 Oct o ber 2 0 2 3
8. 6. 4.   
A d verse E ve nts
Cli nical a n d la b orat or y A Es will be c o de d usi n g t he Me d D R A. S yste m or ga n class, hi g h-le vel 
gr o u p ter m, hi g h-le vel ter m, preferre d ter m, a n d l o wer-le vel ter m will be attac he d t o t he cli nical 
data base.
E ve nts will be s u m marize d o n t he basis of t he date of o nset f or t he e ve nt. A treat me nt-e mer ge nt 
A E will be defi ne d as a n y A E t hat be gi ns o n or after t he date of t he first d ose of a n y st u d y dr u g 
u p t o 3 0 da ys after t he date of t he last d ose of a n y st u d y dr u g or t he da y bef ore i nitiati o n of 
s u bse q ue nt a ntica ncer t hera p y, w hic he ver occ urs first.
S u m maries ( n u m ber a n d perce nta ge of patie nts) of treat me nt-e mer ge nt A Es ( b y s yste m or ga n 
class a n d preferre d ter m) will be pr o vi de d b y c o h ort ( Safet y R u n-i n C o h ort 1, P hase 2 
C o h orts 1a, 1 b, a n d 1c, res pecti vel y).
8. 6. 5.  
L a b or at or y E v al u ati o ns
Selecte d la b orat or y data ( usi n g c o n ve nti o nal u nits) will be s u m marize d usi n g o nl y o bser ve d data. 
Data a n d c ha n ge fr o m baseli ne at all sc he d ule d ti me p oi nts will be s u m marize d.
Gra de d la b orat or y a b n or malities will be defi ne d usi n g t he gra di n g sc he me i n A p pe n di x 5 .
I nci de nce of treat me nt-e mer ge nt la b orat or y a b n or malities, defi ne d as val ues t hat i ncrease at least 
1 t o xicit y gra de fr o m baseli ne at a n y ti me p oi nt p ost baseli ne, u p t o a n d i ncl u di n g t he date of t he 
last d ose of st u d y dr u g pl us 3 0 da ys or t he da y bef ore i nitiati o n of ne w a ntica ncer t hera p y, 
w hic he ver is earlier, will be s u m marize d b y c o h ort ( Safet y R u n-i n C o h ort 1, P hase 2 C o h orts 1a, 
1 b, a n d 1c, res pecti vel y). If baseli ne data are missi n g, t he n a n y gra de d a b n or malit y (ie, at least a 
Gra de 1) will be c o nsi dere d treat me nt-e mer ge nt.
La b orat or y a b n or malities t hat occ ur bef ore t he first d ose of st u d y dr u g or after t he patie nt has 
bee n disc o nti n ue d fr o m treat me nt f or at least 3 0 da ys will be i ncl u de d i n a data listi n g.
8. 6. 6.   
Ot her S afet y E v al u ati o ns
Vital si g ns a n d p h ysical e xa mi nati o n fi n di n gs will be s u m marize d b y c o h ort ( Safet y R u n-i n 
C o h ort 1, P hase 2 C o h orts 1a, 1 b, a n d 1c, res pecti vel y). Details will be pr o vi de d i n t he statistical 
a nal ysis pla n.
8. 7.  
P h ar m ac o ki netic A n al ysis
T he P K A nal ysis Set will be use d f or s u m maries of P K c o nce ntrati o n of ma gr oli ma b vers us ti me. 
Ser u m c o nce ntrati o ns will be liste d a n d s u m marize d f or ma gr oli ma b usi n g descri pti ve statistics 
b y sa m pli n g ti me p oi nt a n d treat me nt. Gra p hical pl ots of i n di vi d ual ser u m c o nce ntrati o n vers us 
ti me a n d mea n c o nce ntrati o n vers us ti me b y treat me nt will be ge nerate d. All data fr o m t his st u d y 
ma y be c o m bi ne d wit h P K data fr o m ot her c o m pa n y s p o ns ore d cli nical st u dies a n d a nal yze d 
usi n g a p o p ulati o n P K m o del. S uc h a n a nal ysis w o ul d be re p orte d se paratel y.

M a gr oli m a b 
Gil e a d S c ie n c es , I n c. 
8. 8.  
I m m u n o g e ni cit y A n al ysis 
Pr ot o c ol  G S -U S - 5 48- 5 9 1 8 
A m e n d m e nt s 
I m m u no g e ni cit y w ill b e  ass ess e d  us i n g a  3- ti er-s cre e n , c o nf n m at o 1 y , a n d tit er-a p pr o a c h  o n 
st u d y s a m pl e s. T h e  r at e a n d m a g nit u d e of a nti- m a gr oli m a b  a nti b o d y  i n ci d e n c e, pr e v a l e n c e, 
p er s ist en c e , a n d tr a nsi e n c e  w ill b e  su m m a ri z e d f or t h e I m m u no  
A n al  sis  S et.  Ti t er 
su m m ari e s m a 
al s o  b e  e n er at e d  if rel e v a nt. 
8. 9.  
Bi o m a r k e r  A n al ysis 
T h e  b a s e li ne l e v e l, a bs ol ut e  l ev e l, a n d  c h a n g e  fro m  b a s e li ne l e v e l o v e r ti m e wi ll b e  su m m ari z e d 
u si n g d e s cri ptiv e  statisti cs  f or e a c h  bi o m a r k er at  s a m  l e c o lle cti o n  ti m e  o i nt  b  c o h ort , as 
8. 1 0.  
S a m pl e  S i z e 
T a bl e 1 3 pr e s ent s t h e s am pl e  si z e  c al c ul ati o n s.  F or  P h a s e  2  C o h o 1i  1,  a  s am pl e  si z e of  3 0  p ati e nts 
i n t h e m N S C L C  c o h o 1i  a n d  4 0  p ati e nts f or t h e  mS C L C  c o h o 1i w er e  c al c ul at e d u s i ng  o n e s am pl e 
pr o p o 1ii o n  t est.  T h e  s a mpl e  si z e of  2 6  p ati e nts  f or t h e m U C  c o h o 1i  w as  c al c ul at e d  us i n g e x a ct 
m et h o d  i nst ea d of o n e  s am pl e  t e st d u e  t o s m aller  s a mpl e  si z e . 
T a bl e  1 3. 
S a m pl e  S i z e C al c ul ati o n s 
1- s i d e d 
T u m o r  T y p e  
S a m pl e  Si z e  
N ull O R R 
Alt e m ati v e  O R R 
al p h a 
P o w e 1· 
m N S C L C 
3 0 
1 3 % 
2 5 % 
0. 2 
8 1 % 
m U C 
2 6 
1 2. 4 % 
2 8 % 
0. 1 
7 8 % 
m S C L C 
4 0 
9 % 
2 0 % 
0. 1 5 
8 4 % 
m N S C L C  =  m et a s t ati c n o ~ m a ll c ell  lu n g  c a n c er ; m S C L C  =  m et ast ati c  s m all  c e ll lu n g  c a n c er ;  mU C  =  m et ast ati c  ur ot h eli a l 
c a n c er ; O R R =  o bj e cti v e  r esp o n s e r at e 
T h e  n ull  O R R  f or e a c h of t h e res p e cti v e  t u m or c o h o rts  ar e  b a s e d o n  h i st oric a l t a x a n e effi c a c y 
d at a  i n t h e s e c on d li n e s etti n g { B ell m u nt  2 0 1 7 , Ritt m e y er  2 0 1 7 , S mit  1 9 9 8 }.  P o w e r c al c ul ati o ns 
w er e  p erf o n n e d  u s i ng  E A S T  6. 5  a n d  n Q u e 1 y 8. 0. 
C O N FI D E N TI A L 
P a g e  8 2 
2 4  O c to b er  2 0 2 3 

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 8 3
2 4 Oct o ber 2 0 2 3
9.   
R E S P O N SI BI LI TI E S
9. 1.  
I n vesti g at or Res p o nsi bilities
9. 1. 1.   
G o o d Cli nic al Pr actice
T he i n vesti gat or will e ns ure t hat t his st u d y is c o n d ucte d i n acc or da nce wit h I nter nati o nal C o u ncil 
f or Har m o nisati o n (I C H) E 6( R 2) a d de n d u m t o its g ui deli ne f or G C P a n d a p plica ble la ws a n d 
re g ulati o ns.
9. 1. 2.  
Fi n a nci al Discl os ure
T he i n vesti gat or a n d s u bi n vesti gat ors will pr o vi de pr o m pt a n d acc urate d oc u me ntati o n of t heir 
fi na ncial i nterest or arra n ge me nts wit h Gilea d, or pr o prietar y i nterests i n t he st u d y dr u g d uri n g 
t he c o urse of a cli nical st u d y. T his d oc u me ntati o n m ust be pr o vi de d pri or t o t he i n vesti gat or’s 
(a n d a n y s u bi n vesti gat or’s) partici pati o n i n t he st u d y. T he i n vesti gat or a n d s u bi n vesti gat or a gree 
t o n otif y Gilea d of a n y c ha n ge i n re p orta ble i nterests d uri n g t he st u d y a n d f or 1 year f oll o wi n g 
c o m pleti o n of t he st u d y. St u d y c o m pleti o n is defi ne d as t he date w he n t he last patie nt c o m pletes 
t he pr ot oc ol- defi ne d acti vities.
9. 1. 3.  
I nstit uti o n al Re vie w B o ar d/I n de pe n de nt Et hics C o m mittee Re vie w a n d 
A p pr o v al
T he i n vesti gat or ( or Gilea d as a p pr o priate acc or di n g t o l ocal re g ulati o ns) will s u b mit t his 
pr ot oc ol, I C F, a n d a n y acc o m pa n yi n g material t o be pr o vi de d t o t he patie nt (s uc h as 
a d vertise me nts, patie nt i nf or mati o n s heets, or descri pti o ns of t he st u d y use d t o o btai n i nf or me d 
c o nse nt) t o a n I R B/I E C. T he i n vesti gat or will n ot be gi n a n y st u d y patie nt acti vities u ntil 
a p pr o val fr o m t he I R B/I E C has bee n d oc u me nte d a n d pr o vi de d as a letter t o t he i n vesti gat or.
Bef ore i m ple me ntati o n, t he i n vesti gat or will s u b mit t o a n d recei ve d oc u me nte d a p pr o val fr o m 
t he I R B/I E C a n y m o dificati o ns ma de t o t he pr ot oc ol or a n y acc o m pa n yi n g material t o be 
pr o vi de d t o t he patie nt after i nitial I R B/I E C a p pr o val, wit h t he e xce pti o n of t h ose necessar y t o 
re d uce i m me diate ris k t o st u d y patie nts.
9. 1. 4.  
I nf or me d C o nse nt
T he i n vesti gat or is res p o nsi ble f or o btai ni n g writte n i nf or me d c o nse nt fr o m eac h i n di vi d ual 
partici pati n g i n t his st u d y after a de q uate e x pla nati o n of t he ai ms, met h o ds, o bjecti ves, a n d 
p ote ntial hazar ds of t he st u d y bef ore u n derta ki n g a n y st u d y-relate d pr oce d ures. T he i n vesti gat or 
m ust use t he m ost c urre nt I R B-  or I E C-a p pr o ve d I C F f or d oc u me nti n g writte n i nf or me d c o nse nt. 
Eac h I C F ( or asse nt as a p plica ble) will be a p pr o priatel y si g ne d a n d date d b y t he patie nt or t he 
patie nt’s le gall y a ut h orize d re prese ntati ve, t he pers o n c o n d ucti n g t he c o nse nt disc ussi o n, a n d a n 
i m partial wit ness (if re q uire d b y I R B or I E C or l ocal re q uire me nts).

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 8 4
2 4 Oct o ber 2 0 2 3
T he I C F will i nf or m patie nts a b o ut ge n o mic testi n g a n d/ or pla n ne d sa m ple rete nti o n. I n a d diti o n 
t o t he st u d y-s pecific I C F t o be si g ne d b y eac h patie nt partici pati n g i n t he st u d y, patie nts will be 
re q uire d t o d oc u me nt a gree me nt t o pr o vi de a d diti o nal sa m ples or t o all o w t he use of t he 
re mai n der of t heir alrea d y c ollecte d s peci me ns f or 
, i n acc or da nce wit h 
a p plica ble re g ulati o ns. T he res ults of t he tests perf or me d o n t he sa m ples will n ot be gi ve n t o t he 
patie nt or t he i n vesti gat or.
9. 1. 5.   
C o nfi de nti alit y
T he i n vesti gat or m ust e ns ure t hat patie nts’ a n o n y mit y will be strictl y mai ntai ne d a n d t hat t heir 
i de ntities are pr otecte d fr o m u na ut h orize d parties. O nl y a n i de ntificati o n c o de a n d a n y ot her 
u ni q ue i de ntifier(s) as all o we d b y l ocal la w (s uc h as year of birt h) will be rec or de d o n a n y f or m 
or bi ol o gical sa m ple s u b mitte d t o Gilea d, I R B/I E C, or t he la b orat or y. La b orat or y s peci me ns 
m ust be la bele d i n s uc h a wa y as t o pr otect patie nt i de ntit y w hile all o wi n g t he res ults t o be 
rec or de d t o t he pr o per patie nt. Refer t o s pecific la b orat or y i nstr ucti o ns. N O T E: T he i n vesti gat or 
m ust kee p a scree ni n g l o g wit h details f or all patie nts scree ne d a n d e nr olle d i n t he st u d y, i n 
acc or da nce wit h t he site pr oce d ures a n d re g ulati o ns. Patie nt data will be pr ocesse d i n acc or da nce 
wit h all a p plica ble re g ulati o ns.
T he i n vesti gat or a grees t hat all i nf or mati o n recei ve d fr o m Gilea d, i ncl u di n g b ut n ot li mite d t o t he 
I B, t his pr ot oc ol, C R Fs/e C R Fs, st u d y dr u g i nf or mati o n, a n d a n y ot her st u d y i nf or mati o n, re mai n 
t he s ole a n d e xcl usi ve pr o pert y of Gilea d d uri n g t he c o n d uct of t he st u d y a n d t hereafter. T his 
i nf or mati o n is n ot t o be discl ose d t o a n y t hir d part y (e xce pt e m pl o yees or a ge nts directl y 
i n v ol ve d i n t he c o n d uct of t he st u d y or as re q uire d b y la w) wit h o ut pri or writte n c o nse nt fr o m 
Gilea d. T he i n vesti gat or f urt her a grees t o ta ke all reas o na ble preca uti o ns t o pre ve nt t he 
discl os ure b y a n y e m pl o yee or a ge nt of t he st u d y site t o a n y t hir d part y or ot her wise i nt o t he 
p u blic d o mai n.
9. 1. 6.  
St u d y Files a n d Rete nti o n of Rec or ds
T he i n vesti gat or m ust mai ntai n a de q uate a n d acc urate rec or ds t o e na ble t he c o n d uct of t he st u d y 
t o be f ull y d oc u me nte d a n d t he st u d y data t o be s u bse q ue ntl y verifie d. T hese d oc u me nts s h o ul d 
be classifie d i nt o at least t he f oll o wi n g 2 cate g ories: ( 1) i n vesti gat or’s st u d y file, a n d ( 2) patie nt 
cli nical s o urce d oc u me nts.
T he i n vesti gat or’s st u d y file will c o ntai n t he pr ot oc ol/a me n d me nts, C R Fs/e C R Fs, I R B/I E C a n d 
g o ver n me ntal a p pr o val wit h c orres p o n de nce, t he I C F, dr u g rec or ds, staff c urric ul u m vitae a n d 
a ut h orizati o n f or ms, a n d ot her a p pr o priate d oc u me nts a n d c orres p o n de nce.
T he re q uire d s o urce data s h o ul d i ncl u de se q ue ntial n otes c o ntai ni n g at least t he f oll o wi n g 
i nf or mati o n f or eac h patie nt:
•
Patie nt i de ntificati o n
•
D oc u me ntati o n t hat patie nt meets eli gi bilit y criteria (ie, me dical hist or y, p h ysical 
e xa mi nati o n, a n d c o nfir mati o n of dia g n osis [t o s u p p ort i ncl usi o n a n d e xcl usi o n criteria])
C CI

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 8 5
2 4 Oct o ber 2 0 2 3
•
D oc u me ntati o n of t he reas o n(s) a c o nse nte d patie nt is n ot e nr olle d
•
Partici pati o n i n st u d y (i ncl u di n g st u d y n u m ber)
•
St u d y disc usse d a n d date of i nf or me d c o nse nt
•
Dates of all visits
•
D oc u me ntati o n t hat pr ot oc ol-s pecific pr oce d ures were perf or me d
•
Res ults of efficac y para meters, as re q uire d b y t he pr ot oc ol
•
Start a n d e n d date (i ncl u di n g d ose re gi me n) of st u d y dr u g, i ncl u di n g dates of dis pe nsi n g a n d 
ret ur n
•
Rec or d of all A Es a n d ot her safet y para meters (start a n d e n d date, a n d i ncl u di n g ca usalit y 
a n d se verit y) a n d d oc u me ntati o n t hat a de q uate me dical care has bee n pr o vi de d f or a n y A E
•
C o nc o mita nt me dicati o n (start a n d e n d date; d ose if rele va nt; d ose c ha n ges)
•
Date of st u d y c o m pleti o n a n d reas o n f or earl y disc o nti n uati o n, if it occ urs
All cli nical st u d y d oc u me nts m ust be retai ne d b y t he i n vesti gat or f or at least 2 years or acc or di n g 
t o l ocal la ws, w hic he ver is l o n ger, after t he last a p pr o val of a mar keti n g a p plicati o n i n a n I C H 
re gi o n (ie, U S, E ur o pe, or Ja pa n) a n d u ntil t here are n o pe n di n g or pla n ne d mar keti n g 
a p plicati o ns i n a n I C H re gi o n; or, if n o a p plicati o n is file d or if t he a p plicati o n is n ot a p pr o ve d 
f or s uc h i n dicati o n, f or 2 years after t he i n vesti gati o n is disc o nti n ue d a n d re g ulat or y a ut h orities 
ha ve bee n n otifie d. I n vesti gat ors ma y be re q uire d t o retai n d oc u me nts l o n ger if s pecifie d b y 
re g ulat or y re q uire me nts, b y l ocal re g ulati o ns, or b y a n a gree me nt wit h Gilea d. T he i n vesti gat or 
m ust n otif y Gilea d bef ore destr o yi n g a n y cli nical st u d y rec or ds.
S h o ul d t he i n vesti gat or wis h t o assi g n t he st u d y rec or ds t o a n ot her part y or m o ve t he m t o a n ot her 
l ocati o n, Gilea d m ust be n otifie d i n a d va nce.
If t he i n vesti gat or ca n n ot pr o vi de f or t his arc hi vi n g re q uire me nt at t he st u d y site f or a n y or all of 
t he d oc u me nts, s pecial arra n ge me nts m ust be ma de bet wee n t he i n vesti gat or a n d Gilea d t o st ore 
t hese rec or ds sec urel y a wa y fr o m t he site s o t hat t he y ca n be ret ur ne d seale d t o t he i n vesti gat or 
i n case of a n i ns pecti o n. W he n s o urce d oc u me nts are re q uire d f or t he c o nti n ue d care of t he 
patie nt, a p pr o priate c o pies s h o ul d be ma de f or st ora ge a wa y fr o m t he site.
9. 1. 7.   
C ase Re p ort F or ms
F or eac h patie nt c o nse nte d, a n e C R F case b o o k will be c o m plete d b y a n a ut h orize d st u d y staff 
me m ber w h ose trai ni n g f or t his f u ncti o n is c o m plete d i n t he electr o nic data ca pt ure ( E D C) 
s yste m. T he e C R F case b o o k will o nl y ca pt ure t he data re q uire d per t he pr ot oc ol sc he d ules of 
assess me nts. T he I ncl usi o n/ E xcl usi o n Criteria a n d E nr oll me nt e C R Fs s h o ul d be c o m plete d o nl y 
after all data relate d t o eli gi bilit y ha ve bee n recei ve d. Data e ntr y s h o ul d be perf or me d i n 

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 8 6
2 4 Oct o ber 2 0 2 3
acc or da nce wit h t he C R F C o m pleti o n G ui deli nes pr o vi de d b y t he s p o ns or. S u bse q ue nt t o data 
e ntr y, a st u d y m o nit or will perf or m s o urce data verificati o n wit hi n t he E D C s yste m. S yste m-
ge nerate d or ma n ual q ueries will be iss ue d i n t he E D C s yste m as data discre pa ncies are 
i de ntifie d b y t he m o nit or or Gilea d staff w h o r o uti nel y re vie w t he data f or c o m plete ness, 
c orrect ness, a n d c o nsiste nc y. T he site i n vesti gat or, site c o or di nat or, or ot her desi g nee is 
res p o nsi ble f or res p o n di n g t o t he q ueries i n a ti mel y ma n ner, wit hi n t he s yste m, eit her b y 
c o nfir mi n g t he data as c orrect or u p dati n g t he ori gi nal e ntr y, a n d pr o vi di n g t he reas o n f or t he 
u p date (e g, data e ntr y err or). Ori gi nal e ntries as well as a n y c ha n ges t o data fiel ds will be st ore d 
i n t he a u dit trail of t he s yste m. At a mi ni m u m, pri or t o a n y i nteri m ti me p oi nts or data base l oc k 
(as i nstr ucte d b y Gilea d), t he i n vesti gat or will use his/ her l o gi n cre de ntials t o c o nfir m t hat t he 
f or ms ha ve bee n re vie we d, a n d t hat t he e ntries acc uratel y reflect t he i nf or mati o n i n t he s o urce 
d oc u me nts. At t he c o ncl usi o n of t he st u d y, Gilea d will pr o vi de t he site i n vesti gat or wit h a rea d-
o nl y arc hi ve c o p y of t he data e ntere d b y t hat site. T his arc hi ve m ust be st ore d i n acc or da nce wit h 
t he rec or ds rete nti o n re q uire me nts o utli ne d i n Secti o n 9. 1. 6 .
9. 1. 8.  
I n vesti g at or I ns pecti o ns
T he i n vesti gat or will ma ke a vaila ble all s o urce d oc u me nts a n d ot her rec or ds f or t his st u d y t o 
Gilea d’s a p p oi nte d st u d y m o nit ors, t o I R Bs/I E Cs, or t o re g ulat or y a ut h orit y or healt h a ut h orit y 
i ns pect ors.
9. 1. 9.  
Pr ot oc ol C o m pli a nce
T he i n vesti gat or is res p o nsi ble f or e ns uri n g t he st u d y is c o n d ucte d i n acc or da nce wit h t he 
pr oce d ures a n d e val uati o ns descri be d i n t his pr ot oc ol.
9. 2.  
S p o ns or Res p o nsi bilities
9. 2. 1.  
Pr ot oc ol M o dific ati o ns
Pr ot oc ol m o dificati o ns ma y be ma de o nl y b y t he s p o ns or.
9. 2. 2.  
St u d y Re p ort a n d P u blic ati o ns
A cli nical st u d y re p ort ( C S R) will be pre pare d a n d pr o vi de d t o t he re g ulat or y a ge ncies w he n 
a p plica ble a n d i n acc or da nce wit h l ocal re g ulat or y re q uire me nts. Gilea d will e ns ure t hat t he 
re p ort meets t he sta n dar ds set o ut i n t he I C H G ui deli ne f or Str uct ure a n d C o nte nt of Cli nical 
St u d y Re p orts (I C H E 3). N ote t hat a n a b bre viate d re p ort ma y be pre pare d i n certai n cases. F or 
st u dies wit h sites i n c o u ntries f oll o wi n g t he E U Re g ulati o n N o. 5 3 6/ 2 0 1 4, a C S R will be 
s u b mitte d wit hi n 1 year ( 6 m o nt hs f or pe diatric st u dies, i n acc or da nce wit h Re g ulati o n [ E C] 
N o. 1 9 0 1/ 2 0 0 6) after t he gl o bal e n d of st u d y (as defi ne d i n Secti o n 3. 5 ).
I n vesti gat ors i n t his st u d y ma y c o m m u nicate, orall y prese nt, or p u blis h st u d y data i n scie ntific 
j o ur nals or ot her sc h olarl y me dia i n acc or da nce wit h t he Gilea d cli nical trial a gree me nt:

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 8 7
2 4 Oct o ber 2 0 2 3
9. 3.  
J oi nt I n vesti g at or/ S p o ns or Res p o nsi bilities
9. 3. 1.  
P a y me nt Re p orti n g
I n vesti gat ors a n d t heir st u d y staff ma y be as ke d t o pr o vi de ser vices perf or me d u n der t his 
pr ot oc ol (e g, atte n da nce at i n vesti gat or meeti n gs). If re q uire d u n der t he a p plica ble stat ut or y a n d 
re g ulat or y re q uire me nts, Gilea d will ca pt ure a n d discl ose t o fe deral a n d state a ge ncies a n y 
e x pe nses pai d or rei m b urse d f or s uc h ser vices, i ncl u di n g a n y cli nical st u d y pa y me nts, meal, 
tra vel e x pe nses or rei m b urse me nts, c o ns ulti n g fees, a n d a n y ot her tra nsfer of val ue.
9. 3. 2.   
Access t o I nf or m ati o n f or M o nit ori n g
T he m o nit or is res p o nsi ble f or r o uti ne re vie w of t he C R F/e C R F at re g ular i nter vals t hr o u g h o ut 
t he st u d y t o verif y a d here nce t o t he pr ot oc ol a n d t he c o m plete ness, c o nsiste nc y, a n d acc urac y of 
t he data bei n g e ntere d o n t he m. T he m o nit or s h o ul d ha ve access t o a n y patie nt rec or ds nee de d t o 
verif y t he e ntries i n t he C R F/e C R F. T he i n vesti gat or a grees t o c o o perate wit h t he m o nit or t o 
e ns ure t hat a n y pr o ble ms detecte d t hr o u g h a n y t y pe of m o nit ori n g (ce ntral, o n site) are res ol ve d.
9. 3. 3.   
Access t o I nf or m ati o n f or A u diti n g or I ns pecti o ns
Re prese ntati ves of re g ulat or y a ut h orities or Gilea d ma y c o n d uct i ns pecti o ns or a u dits of t he 
cli nical st u d y. If t he i n vesti gat or is n otifie d of a n i ns pecti o n b y a re g ulat or y a ut h orit y, t he 
i n vesti gat or a grees t o n otif y t he Gilea d me dical m o nit or i m me diatel y. T he i n vesti gat or a grees t o 
pr o vi de t o re prese ntati ves of a re g ulat or y a ge nc y or Gilea d access t o rec or ds, facilities, a n d 
pers o n nel f or t he effecti ve c o n d uct of a n y i ns pecti o n or a u dit.
9. 3. 4.  
St u d y Disc o nti n u ati o n
B ot h Gilea d a n d t he i n vesti gat or reser ve t he ri g ht t o ter mi nate t he st u d y at a n y ti me. S h o ul d t his 
be necessar y, b ot h parties will arra n ge disc o nti n uati o n pr oce d ures a n d n otif y t he patie nts, 
a p pr o priate re g ulat or y a ut h orit y, I R Bs, a n d I E Cs. I n ter mi nati n g t he st u d y, Gilea d a n d t he 
i n vesti gat or will e ns ure t hat a de q uate c o nsi derati o n is gi ve n t o t he pr otecti o n of t he patie nts’ 
i nterests.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 8 8
2 4 Oct o ber 2 0 2 3
1 0.   
R E F E R E N C E S
A d va ni R, Fli n n I, P o p ple well L, F orer o A, Bartlett N L, G h os h N, et al. C D 4 7 Bl oc ka de b y 
H u 5 F 9- G 4 a n d Rit u xi ma b i n N o n- H o d g ki n's L y m p h o ma. N E n gl J Me d 2 0 1 8; 3 7 9 
( 1 8): 1 7 1 1- 2 1.
Balar A V, Gals k y M D, R ose n ber g J E, P o wles T, Petr yla k D P, Bell m u nt J, et al. Atez oliz u ma b as 
first-li ne treat me nt i n cis plati n-i neli gi ble patie nts wit h l ocall y a d va nce d a n d 
metastatic ur ot helial carci n o ma: a si n gle-ar m, m ultice ntre, p hase 2 trial. La ncet 
2 0 1 7; 3 8 9 ( 1 0 0 6 4): 6 7- 7 6.
Bell m u nt J, de Wit R, Va u g h n DJ, Fra det Y, Lee J L, F o n g L, et al. Pe m br oliz u ma b as Sec o n d-
Li ne T hera p y f or A d va nce d Ur ot helial Carci n o ma. N E n gl J Me d 2 0 1 7; 3 7 6 
( 1 1): 1 0 1 5- 2 6.
Bra h mer J, Lacc hetti C, Sc h nei der B, At ki ns M, Brassil K, Cateri n o J, et al. Ma na ge me nt of 
I m m u ne- Relate d A d verse E ve nts i n Patie nts Treate d Wit h I m m u ne C hec k p oi nt 
I n hi bit or T hera p y: A merica n S ociet y of Cli nical O nc ol o g y Cli nical Practice 
G ui deli ne. J o ur nal of cli nical O nc ol o g y 2 0 1 8; 3 6 ( 1 7).
C ha o M P, Aliza de h A A, Ta n g C, Ja n M, Weiss ma n- Ts u ka m ot o R, Z ha o F, et al. T hera pe utic 
a nti b o d y tar geti n g of C D 4 7 eli mi nates h u ma n ac ute l y m p h o blastic le u ke mia. 
Ca ncer Res 2 0 1 1a; 7 1 ( 4): 1 3 7 4- 8 4.
C ha o M P, Aliza de h A A, Ta n g C, M y kle b ust J H, Var g hese B, Gill S, et al. A nti- C D 4 7 a nti b o d y 
s y ner gizes wit h rit u xi ma b t o pr o m ote p ha g oc yt osis a n d era dicate n o n- H o d g ki n 
l y m p h o ma. Cell 2 0 1 0a; 1 4 2: 6 9 9- 7 1 3.
C ha o M P, Jais wal S, Weiss ma n- Ts u ka m ot o R, Aliza de h A A, Ge ntles AJ, V ol k mer J, et al. 
Calretic uli n Is t he D o mi na nt Pr o- P ha g oc ytic Si g nal o n M ulti ple H u ma n Ca ncers 
a n d Is C o u nter bala nce d b y C D 4 7. Scie nce tra nslati o nal me dici ne 2 0 1 0 b; 2 
( 6 3): 6 3ra 9 4.
C ha o M P, Majeti R, Weiss ma n I L. Pr o gra m me d cell re m o val: a ne w o bstacle i n t he r oa d t o 
de vel o pi n g ca ncer. Nat Re v Ca ncer. 2 0 1 2; 1 2 ( 1): 5 8- 6 7.
C ha o M P, Ta n g C, Pac h y ns ki R K, C hi n R, Majeti R, Weiss ma n I L. E xtra n o dal disse mi nati o n of 
n o n- H o d g ki n l y m p h o ma re q uires C D 4 7 a n d is i n hi bite d b y a nti- C D 4 7 a nti b o d y 
t hera p y. Bl o o d 2 0 1 1 b; 1 1 8 ( 1 8): 4 8 9 0- 9 0 1.
C he n J Y, Mc Ke n na K M, C h oi T S, D ua n J, Br o w n L, Ste wart JJ, et al. R B C- S pecific C D 4 7 
Pr u ni n g C o nfers Pr otecti o n a n d U n derlies t he Tra nsie nt A ne mia i n Patie nts 
Treate d wit h A nti- C D 4 7 A nti b o d y 5 F 9 [ A bstract]. Bl o o d ( A S H A n n ual Meeti n g 
A bstracts) 2 0 1 8; 1 3 2 ( S u p pl 1): 2 3 2 7.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 8 9
2 4 Oct o ber 2 0 2 3
E dris B, Weis k o pf K, V ol k mer A K, V ol k mer J P, Willi n g ha m S B, C o ntreras- Tr ujill o H, et al. 
A nti b o d y t hera p y tar geti n g t he C D 4 7 pr otei n is effecti ve i n a m o del of a g gressi ve 
metastatic lei o m y osarc o ma. Pr oc Natl Aca d Sci U S A 2 0 1 2; 1 0 9 ( 1 7): 6 6 5 6- 6 1.
Eise n ha uer E A, T herasse P, B o gaerts J, Sc h wartz L H, Sar ge nt D, F or d R, et al. Ne w Res p o nse 
E val uati o n Criteria i n S oli d T u m o urs: Re vise d R E CI S T G ui deli ne ( Versi o n 1. 1). 
E ur J Ca ncer 2 0 0 9; 4 5 ( 2): 2 2 8- 4 7.
Etti n ger D S, W o o d D E, A g gar wal C, Ais ner D L, A kerle y W, Ba u ma n J R, et al. N C C N 
G ui deli nes I nsi g hts: N o n- S mall Cell L u n g Ca ncer, Versi o n 1. 2 0 2 0. J Natl C o m pr 
Ca nc Net w 2 0 1 9; 1 7 ( 1 2): 1 4 6 4- 7 2.
Fis her G A, La k ha ni NJ, E n g C, Hec ht J R, Be n dell J C, P hili p P A, et al. A p hase I b/II st u d y of t he 
a nti- C D 4 7 a nti b o d y ma gr oli ma b wit h cet u xi ma b i n s oli d t u m or a n d c ol orectal 
ca ncer patie nts [ A bstract 1 1 4]. Gastr oi ntesti nal Ca ncers S y m p osi u m; 2 0 2 0 2 3- 2 5 
Ja n uar y; Sa n Fra ncisc o, C A. 
H or n L, Ma nsfiel d A S, Szczes na A, Ha vel L, Krza k o ws ki M, H oc h mair MJ, et al. First- Li ne 
Atez oliz u ma b pl us C he m ot hera p y i n E xte nsi ve- Sta ge S mall- Cell L u n g Ca ncer. N 
E n gl J Me d 2 0 1 8; 3 7 9 ( 2 3): 2 2 2 0- 9.
Jais wal S, Ja mies o n C H, Pa n g W W, Par k C Y, C ha o M P, Majeti R, et al. C D 4 7 Is U p- Re g ulate d 
o n Circ ulati n g He mat o p oietic Ste m Cells a n d Le u ke mia Cells t o A v oi d 
P ha g oc yt osis. Cell 2 0 0 9; 1 3 8 ( 2): 2 7 1- 8 5.
Ki m D, Wa n g J, Willi n g ha m S B, Marti n R, Wer ni g G, Weiss ma n I L. A nti- C D 4 7 a nti b o dies 
pr o m ote p ha g oc yt osis a n d i n hi bit t he gr o wt h of h u ma n m yel o ma cells. Le u ke mia 
2 0 1 2; 2 6 ( 1 2): 2 5 3 8- 4 5.
Li u J, Wa n g L, Z ha o F, Tse n g S, Nara ya na n C, S h ura L, et al. Pre- Cli nical De vel o p me nt of a 
H u ma nize d A nti- C D 4 7 A nti b o d y wit h A nti- Ca ncer T hera pe utic P ote ntial. P L o S 
O ne. 2 0 1 5a; 1 0 ( 9):e 0 1 3 7 3 4 5.
Li u X, P u Y, Cr o n K, De n g L, Kli ne J, Frazier W A, et al. C D 4 7 bl oc ka de tri g gers T cell-
me diate d destr ucti o n of i m m u n o ge nic t u m ors. Nat Me d 2 0 1 5 b; 2 1 ( 1 0): 1 2 0 9- 1 5.
Majeti R, C ha o M P, Aliza de h A A, Pa n g W W, Jais wal S, Gi b bs K D, Jr., et al. C D 4 7 Is a n 
A d verse Pr o g n ostic Fact or a n d T hera pe utic A nti b o d y Tar get o n H u ma n Ac ute 
M yel oi d Le u ke mia Ste m Cells. Cell 2 0 0 9; 1 3 8 ( 2): 2 8 6- 9 9.
O ke n M M, Creec h R H, T or me y D C, H ort o n J, Da vis T E, Mc Fa d de n E T, et al. T o xicit y a n d 
res p o nse criteria of t he Easter n C o o perati ve O nc ol o g y Gr o u p. A m J Cli n O nc ol 
1 9 8 2; 5 ( 6): 6 4 9- 5 5.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 9 0
2 4 Oct o ber 2 0 2 3
Paz ‑Ares L, D v or ki n M, C he n Y, Rei n m ut h N, H otta K, Tr u k hi n D, et al. D ur val u ma b pl us 
plati n u m-et o p osi de vers us plati n u m-et o p osi de i n first-li ne treat me nt of e xte nsi ve-
sta ge s mall-cell l u n g ca ncer ( C A S PI A N): a ra n d o mise d, c o ntr olle d, o pe n-la bel, 
p hase 3 trial. La ncet 2 0 1 9; 3 9 4 ( 1 0 2 1 2): 1 9 2 9- 3 9.
Ritt me yer A, Barlesi F, Water ka m p D, Par k K, Ciar diell o F, v o n Pa wel J, et al. Atez oliz u ma b 
vers us d oceta xel i n patie nts wit h pre vi o usl y treate d n o n-s mall-cell l u n g ca ncer 
( O A K): a p hase 3, o pe n-la bel, m ultice ntre ra n d o mise d c o ntr olle d trial. La ncet 
2 0 1 7; 3 8 9 ( 1 0 0 6 6): 2 5 5- 6 5.
R ossi A, Di Mai o M, C hi o di ni P, R u d d R M, O ka m ot o H, S karl os D V, et al. Car b o plati n- or 
cis plati n- base d c he m ot hera p y i n first-li ne treat me nt of s mall-cell l u n g ca ncer: t he 
C O CI S meta-a nal ysis of i n di vi d ual patie nt data. J Cli n O nc ol 2 0 1 2; 3 0 ( 1 4): 1 6 9 2-
8.
Sall ma n D A, Asc h A, Al- Mal ki M, Lee D, Garcia- Ma ner o G, D o n nella n W, et al. T olera bilit y 
a n d Efficac y of t he First-i n- Class A nti- C D 4 7 A nti b o d y Ma gr oli ma b C o m bi ne d 
Wit h Azaciti di ne i n M D S a n d A M L Patie nts: P hase 1 b Res ults [ Prese ntati o n]. 
A merica n S ociet y of Cli nical O nc ol o g y ( A S C O) A n n ual Meeti n g Virt ual; 2 0 2 0. 
S he p her d F A, Da nce y J, Ra mla u R, Matts o n K, Gralla R, O' R o ur ke M, et al. Pr os pecti ve 
ra n d o mize d trial of d oceta xel vers us best s u p p orti ve care i n patie nts wit h n o n-
s mall-cell l u n g ca ncer pre vi o usl y treate d wit h plati n u m- base d c he m ot hera p y. J 
Cli n O nc ol 2 0 0 0; 1 8 ( 1 0): 2 0 9 5- 1 0 3.
Si kic BI, La k ha ni N, Pat nai k A, S ha h S A, C ha n da na S R, Rasc o D, et al. First-i n- H u ma n, First-
i n- Class P hase I Trial of t he A nti- C D 4 7 A nti b o d y H u 5 F 9- G 4 i n Patie nts Wit h 
A d va nce d Ca ncers. J Cli n O nc ol 2 0 1 9; 3 7 ( 1 2): 9 4 6- 5 3.
Si kic BI, Pa d da S K, S ha h S A, C ole vas A D, Nara ya na n S, Fis her G A, et al. A first-i n- h u ma n, 
first-i n-class p hase I trial of t he a nti- C D 4 7 a nti b o d y H u 5 F 9- G 4 i n patie nts wit h 
a d va nce d ca ncers.  2 0 1 6:
S mit E F, F o k ke ma E, Bies ma B, Gr oe n HJ, S n oe k W, P ost m us P E. A p hase II st u d y of paclita xel 
i n hea vil y pretreate d patie nts wit h s mall-cell l u n g ca ncer. Br J Ca ncer 1 9 9 8; 7 7 
( 2): 3 4 7- 5 1.
Ta x otere ®, Gilea d Scie nces I nc. Ta x otere ® ( d oceta xel) S u m mar y of Pr o d uct C haracteristics. 
F oster Cit y, C A. Re vise d 0 6/ 2 0 2 0.  1 9 9 5:
Ta x otere ®, Gilea d Scie nces I nc. Ta x otere ® ( d oceta xel) I njecti o n C o nce ntrate, I ntra ve n o us 
I nf usi o n. U. S. Prescri bi n g I nf or mati o n. F oster Cit y, C A. Re vise d 0 5/ 2 0 2 1.  1 9 9 6:
Tr o u g ht o n M C, Si m m o ns L W, La n gle y C, Y o ussef M, Mar q ues M B. A N o vel Use of H u ma n 
Platelet C o nce ntrate t o Res ol ve I nterfere nce of A nti- C D 4 7 i n Ser ol o gic Testi n g 
[I G T 4 6]. Tra nsf usi o n 2 0 1 8; 5 8 ( S 2): 1 7 9 A- 8 0 A.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 9 1
2 4 Oct o ber 2 0 2 3
Tse n g D, V ol k mer J P, Willi n g ha m S B, C o ntreras- Tr ujill o H, Fat h ma n J W, Fer n h off N B, et al. 
A nti- C D 4 7 a nti b o d y- me diate d p ha g oc yt osis of ca ncer b y macr o p ha ges pri mes a n 
effecti ve a ntit u m or T-cell res p o nse. Pr oc Natl Aca d Sci U S A 2 0 1 3; 1 1 0 
( 2 7): 1 1 1 0 3- 8.
U. S. De part me nt of Healt h a n d H u ma n Ser vices, F o o d a n d Dr u g A d mi nistrati o n, Ce nter f or 
Dr u g E val uati o n a n d Researc h ( C D E R), Ce nter f or Bi ol o gics E val uati o n a n d 
Researc h ( C B E R). G ui da nce f or I n d ustr y Dr u g-I n d uce d Li ver I nj ur y:  
Pre mar keti n g Cli nical E val uati o n.  J ul y, 2 0 0 9.
Va n C utse m E, Ma yer RJ, La ure nt S, Wi n kler R, Gra val os C, Be na vi des M, et al. T he s u b gr o u ps 
of t he p hase III R E C O U R S E trial of trifl uri di ne/ti piracil ( T A S- 1 0 2) vers us 
place b o wit h best s u p p orti ve care i n patie nts wit h metastatic c ol orectal ca ncer. 
E ur J Ca ncer 2 0 1 8; 9 0: 6 3- 7 2.
Velli q uette R W, Aesc hli ma n n J, Kir ke gaar d J, S ha karia n G, L o mas- Fra ncis C, West h off C M. 
M o n ocl o nal a nti- C D 4 7 i nterfere nce i n re d cell a n d platelet testi n g. Tra nsf usi o n 
2 0 1 9; 5 9 ( 2): 7 3 0- 7.
v o n der Maase H, Ha nse n S W, R o berts J T, D o gli otti L, Oli ver T, M o ore MJ, et al. Ge mcita bi ne 
a n d cis plati n vers us met h otre xate, vi n blasti ne, d o x or u bici n, a n d cis plati n i n 
a d va nce d or metastatic bla d der ca ncer: res ults of a lar ge, ra n d o mize d, 
m ulti nati o nal, m ultice nter, p hase III st u d y. J Cli n O nc ol 2 0 0 0; 1 8 ( 1 7): 3 0 6 8- 7 7.
V u k y J, Balar A V, Castella n o D, O' D o n nell P H, Gri vas P, Bell m u nt J, et al. L o n g- Ter m 
O utc o mes i n K E Y N O T E- 0 5 2: P hase II St u d y I n vesti gati n g First- Li ne 
Pe m br oliz u ma b i n Cis plati n-I neli gi ble Patie nts Wit h L ocall y A d va nce d or 
Metastatic Ur ot helial Ca ncer. J Cli n O nc ol 2 0 2 0; 3 8 ( 2 3): 2 6 5 8- 6 6.
Willi n g ha m S B, V ol k mer J P, Ge ntles AJ, Sa h o o D, Daler ba P, Mitra S S, et al. T he C D 4 7-si g nal 
re g ulat or y pr otei n al p ha ( SI R Pa) i nteracti o n is a t hera pe utic tar get f or h u ma n 
s oli d t u m ors. Pr oc Natl Aca d Sci U S A 2 0 1 2; 1 0 9 ( 1 7): 6 6 6 2- 7.
Ya ma m ot o N, Ts ur uta ni J, Y os hi m ura N, Asai G, M ori ya ma A, Na ka ga wa K, et al. P hase II 
st u d y of wee kl y paclita xel f or rela pse d a n d refract or y s mall cell l u n g ca ncer. 
A ntica ncer Res 2 0 0 6; 2 6 ( 1 B): 7 7 7- 8 1.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 9 2
2 4 Oct o ber 2 0 2 3
1 1.   
A P P E N DI C E S
A p pe n di x 1.  
I n vesti gat or Si g nat ure Pa ge
A p pe n di x 2.   
Mar keti n g A ut h orizati o n Stat us of St u d y I nter ve nti o ns
A p pe n di x 3.  
Sc he d ules of Assess me nt
A p pe n di x 4.  
Pa n de mic Ris k Assess me nt a n d Miti gati o n Pla n
A p pe n di x 5.  
T o xicit y Gra di n g Scale f or Se verit y of A d verse E ve nts a n d La b orat or y 
A b n or malities
A p pe n di x 6.  
Pre g na nc y Preca uti o ns, Defi niti o n f or Fe male of C hil d beari n g P ote ntial, a n d 
C o ntrace pti ve Re q uire me nts
A p pe n di x 7.  
Easter n C o o perati ve O nc ol o g y Gr o u p ( E C O G) Perf or ma nce Stat us
A p pe n di x 8.  
Res p o nse E val uati o n Criteria i n S oli d T u m ors ( R E CI S T, Versi o n 1. 1)
A p pe n di x 9.  
C o u ntr y- S pecific Re q uire me nts
A p pe n di x 1 0.   
A me n d me nt Hist or y

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 9 3
2 4 Oct o ber 2 0 2 3
A p pe n di x 1.  
I n vesti g at or Si g n at ure P a ge
GI L E A D S CI E N C E S, I N C.
3 3 3 L A K E SI D E D RI V E
F O S T E R CI T Y, C A 9 4 4 0 4
S T U D Y A C K N O W L E D G M E N T
A P hase 2, M ulti- Ar m St u d y of Ma gr oli ma b i n Patie nts wit h S oli d T u m ors
G S- U S- 5 4 8- 5 9 1 8 A me n d me nt 5; 2 4 Oct o ber 2 0 2 3
T his pr ot oc ol has bee n a p pr o ve d b y Gilea d Scie nces, I nc. T he f oll o wi n g si g nat ure d oc u me nts 
t his a p pr o val.
[ See a p pe n de d electr o nic si g n at ure]
Na me ( Pri nte d)
Me dical M o nit or
Si g nat ure
[ See a p pe n de d electr o nic si g n at ure]
Date
I N V E S TI G A T O R S T A T E M E N T
I ha ve rea d t he pr ot oc ol, i ncl u di n g all a p pe n dices, a n d I a gree t hat it c o ntai ns all necessar y 
details f or me a n d m y staff t o c o n d uct t his st u d y as descri be d. I will c o n d uct t his st u d y as 
o utli ne d herei n a n d will ma ke a reas o na ble eff ort t o c o m plete t he st u d y wit hi n t he ti me 
desi g nate d.
I will pr o vi de all st u d y pers o n nel u n der m y s u per visi o n c o pies of t he pr ot oc ol a n d access t o all 
i nf or mati o n pr o vi de d b y Gilea d Scie nces, I nc. I will disc uss t his material wit h t he m t o e ns ure 
t hat t he y are f ull y i nf or me d a b o ut t he dr u gs a n d t he st u d y.
Pri nci pal I n vesti gat or Na me ( Pri nte d)
Si g nat ure
Date
Site N u m ber
P P D-

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 9 4
2 4 Oct o ber 2 0 2 3
A p pe n di x 2.   
M ar keti n g A ut h oriz ati o n St at us of St u d y I nter ve nti o ns
St u d y 
I nter ve nti o n 
N a me
C ate g or y
A ut h orize d i n 
≥ 1 C o u ntr y 
F oll o wi n g E U 
Re g ul ati o n 
N o. 5 3 6/ 2 0 1 4
A ut h orize d 
i n ≥ 1 I C H 
C o u ntr y
A ut h orize d b y 
S wiss me dic
Ma gr oli ma b 
St u d y dr u g
N o a
N o a
N o a
D oceta xel
St u d y dr u g
Yes
Yes
Yes
Aceta mi n o p he n
A x M P
Yes
Yes
Yes
Di p he n h y dra mi ne
A x M P
Yes
Yes
Yes
De xa met has o ne
A x M P
Yes
Yes
Yes
A x M P = a u xiliar y me dici nal pr o d uct; E U = E ur o pea n U ni o n; I C H = I nter nati o nal C o u ncil f or Har m o nisati o n ( of Tec h nical 
Re q uire me nts f or P har mace uticals f or H u ma n Use) 
a  
Rati o nale descri be d i n Secti o n 1

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8 
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 9 5
2 4 Oct o ber 2 0 2 3
A p pe n di x 3.  
Sc he d ules of Assess me nt
A p pe n di x T a ble 1. 
S afet y R u n-i n C o h ort 1 a n d P h ase 2 C o h ort 1: Sc he d ule of Assess me nts – Scree ni n g a n d Tre at me nt 
Peri o d 
Visit Wi n d o w ( D a ys)
Scree ni n g
D a y - 3 0 t o - 1
C ycle ( 2 1- d a y c ycles)
1 a
2 a
3 a
4 + a
N o ne 
± 3 b
± 3 b
± 3 b
± 3 b
C ycle D a y
1 
2 
8 
1 5 
1 
8 
1 5 
1
1
I nf or me d c o nse nt
X
De m o gra p hics
X
Me dical a n d ca ncer hist or y
X
E C O G
X
X
X
X
X
Vital si g ns, hei g ht, a n d wei g ht c
X
X
X 
X 
X 
X 
X 
X
X
P h ysical e xa mi nati o n d
X
X
X 
X 
X 
X 
X
X
E C G (si n gle)
X
Pre g na nc y test e 
X
X
X
X
X
He mat ol o g y b, f
X
X f
X 
X f
X 
X 
X 
X 
X
X
Ha pt o gl o bi n a n d L D H b
X
X 
X
Ser u m or plas ma c he mistr y b
X
X
X 
X 
X 
X 
X 
X
X
C oa g ulati o n g
X
Bl o o d, t y pe a n d scree n ( A B O/ R h), D A T, a n d 
e xte n de d R B C p he n ot y pi n g a n d ge n ot y pi n g
X
Uri nal ysis b, h
X
T u m or i ma gi n g i 
X
X, Q 9 W
T u m or bi o ps y 
Refer t o A p pe n di x Ta ble 3

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8 
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 9 6
2 4 Oct o ber 2 0 2 3
Visit Wi n d o w ( D a ys)
Scree ni n g
D a y - 3 0 t o - 1
C ycle ( 2 1- d a y c ycles)
1 a
2 a
3 a
4 + a
N o ne 
± 3 b
± 3 b
± 3 b
± 3 b
C ycle D a y
1 
2 
8 
1 5 
1 
8 
1 5 
1
1
A d verse e ve nts j 
X
C o nc o mita nt me dicati o ns
X
Rece pt or occ u pa nc y
Circ ulati n g t u m or D N A
P B M C
Ser u m a n d plas ma bi o mar kers
W h ole bl o o d R N A
I m m u n o p he n ot y pi n g assa y
T C R se q ue nci n g
St o ol micr o bi o me
Ge n o mic bl o o d sa m ple
P K
A nti dr u g a nti b o dies
Refer t o A p pe n di x Ta ble 3
I R T re gistrati o nk
X
X
X 
X 
X 
X 
X 
X
X
Pre me dicati o n f or ma gr oli ma b l
X
X
Ma gr oli ma b
m
X
X 
X 
X 
X 
X 
X
X
D oceta xel
X
X
X
X
A B O = a n y of t he 4 bl o o d gr o u ps A, B, A B, a n d O c o m prisi n g t he A B O s yste m; a P T T = acti vate d partial t hr o m b o plasti n ti me; C T = c o m p ute d t o m o gra p h y; D A T = direct 
a nti gl o b uli n test; E C G = electr ocar di o gra m; E C O G = Easter n C o o perati ve O nc ol o g y Gr o u p; I N R = i nter nati o nal n or malize d rati o; I R T = I nteracti ve Res p o nse Tec h n ol o g y; 
L D H = lactate de h y dr o ge nase; M RI = ma g netic res o na nce i ma gi n g; P B M C = peri p heral bl o o d m o n o n uclear cell; P K = p har mac o ki netics; P T = pr ot hr o m bi n ti me; P T T = partial 
t hr o m b o plasti n ti me; Q 9 W = e ver y 9 wee ks; R E CI S T = Res p o nse E val uati o n Criteria i n S oli d T u m ors; R h = r hes us; R P 2 D = rec o m me n de d P hase 2 d ose; T C R = T cell rece pt or
N ote: Refer t o Secti o n 6. 5  Safet y Assess me nts f or c o m plete list of a nal ytes t o be teste d.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8 
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 9 7
2 4 Oct o ber 2 0 2 3
a  
I n cases of ma gr oli ma b re pri mi n g f oll o wi n g a treat me nt dela y ( Secti o n 5. 5 ), efficac y, bi o mar ker, P K, a n d i m m u n o ge nicit y assess me nts will f oll o w t he sc he d ule of t he 
assi g ne d c ycle n u m ber. Ma gr oli ma b d osi n g a n d t he safet y assess me nt will f oll o w C ycle 1 (refer t o Ta ble 2  or Ta ble 3  as a p pr o priate), a n d t he n s u bse q ue ntl y s witc h bac k t o 
t he ne xt assi g ne d c ycle sc he d ule. Ma gr oli ma b s h o ul d n ot be gi ve n o n c o nsec uti ve da ys. Refer t o f o ot n ote (l) f or pre me dicati o n re q uire me nt.
b  
Pretreat me nt assess me nts are t o be c ollecte d wit hi n 3 da ys pri or t o a n y st u d y treat me nt a d mi nistrati o n. Wit hi n 2 4 h o urs pri or t o eac h of t he first 2 d oses of ma gr oli ma b 
i nf usi o n d uri n g i nitial treat me nt, all patie nts m ust ha ve a d oc u me nte d he m o gl o bi n ≥ 9 g/ d L. Patie nts w h o d o n ot meet t hese criteria m ust be tra nsf use d a n d ha ve t heir 
he m o gl o bi n rec hec ke d t o meet 9 g/ d L pri or t o eac h of t he first 2 d oses of ma gr oli ma b.
c   
Hei g ht will be c ollecte d at scree ni n g o nl y. Vital si g n meas ure me nts will be c ollecte d pre d ose o n t he sa me da y as i nf usi o n of a n y st u d y treat me nt. Wei g ht will be c ollecte d at 
scree ni n g a n d Da y 1 of eac h c ycle.
d  
C o m plete p h ysical e xa mi nati o n is t o be perf or me d at scree ni n g a n d s y m pt o m- directe d p h ysical e xa mi nati o n is t o be perf or me d fr o m C ycle 1 Da y 1.
e  
Ser u m pre g na nc y test will be c o n d ucte d at scree ni n g. T he C ycle 1 Da y 1 pre g na nc y test d oes n ot nee d t o be re peate d if t he scree ni n g pre g na nc y test was perf or me d wit hi n t he 
7 2 h o urs bef ore st u d y treat me nt a d mi nistrati o n. Uri ne or ser u m pre g na nc y tests will be c o n d ucte d fr o m C ycle 1 Da y 1.
f   
A c o m plete bl o o d c o u nt wit h differe ntial, platelets, a n d retic ul oc ytes will be c o n d ucte d. A n a d diti o nal he m o gl o bi n m ust be c hec ke d  3 t o 6 h o urs after t he i nitiati o n of t he first 
a n d sec o n d d oses of ma gr oli ma b d uri n g i nitial treat me nt (refer t o Secti o n 7. 8. 1. 1 ). Pretreat me nt assess me nts are t o be c ollecte d wit hi n 2 4 h o urs pri or t o t he first 2 ma gr oli ma b 
d oses per Secti o n 7. 8. 1. 1 .
g  
T he a nal ytes t o be teste d are P T, I N R, a n d a P T T ( or P T T).
h  
Refle x micr osc o pic testi n g base d o n ot her a b n or malities.
i  
C T/ M RI will be perf or me d per Secti o n 6. 6 . Per R E CI S T, Versi o n 1. 1, if a patie nt ac hie ves a n i nitial o bjecti ve res p o nse o n i ma gi n g, a n i ma gi n g assess me nt at least 4 wee ks 
later is re q uire d f or c o nfir me d res p o nse. C o nfir mati o n of disease pr o gressi o n t hr o u g h a s u bse q ue nt res p o nse assess me nt at least 4 wee ks a part ma y als o be c o nsi dere d per 
Secti o n 3. 4 . T he o n-treat me nt i ma gi n g wi n d o w is ± 7 da ys.
j   
D uri n g scree ni n g, c ollect a d verse e ve nts relate d t o pr ot oc ol- ma n date d pr oce d ures.
k  
I R T re gistrati o n will be re q uire d f or scree ni n g, e nr oll me nt, a n d w he n dis pe nsi n g a n y st u d y dr u g s u p plie d b y Gilea d.
l  
Pre me dicati o n wit h aceta mi n o p he n a n d di p he n h y dra mi ne is re q uire d pri or t o t he a d mi nistrati o n of t he first 2 d oses of st u d y treat me nt a n d i n case of rei ntr o d ucti o n wit h 
re pri mi n g.
m   
Ma gr oli ma b will be a d mi nistere d first bef ore d oceta xel. All patie nts s h o ul d be m o nit ore d h o url y d uri n g i nf usi o n. Patie nts t o be m o nit ore d (i ncl u di n g meas ure me nt of vital 
si g ns, as cli nicall y a p pr o priate) f or si g ns a n d s y m pt o ms of I R Rs, w hic h ha ve bee n o bser ve d i n pre vi o us ma gr oli ma b st u dies. P osti nf usi o n m o nit ori n g t o be gi n after t he 
i nf usi o n is c o m plete b ut pri or t o a d mi nisteri n g d oceta xel. P osti nf usi o n m o nit ori n g is n ot re q uire d f or d oses after C ycle 1. T he R P 2 D will be deter mi ne d i n Safet y R u n-i n 
C o h ort 1. T he ma gr oli ma b d osi n g re gi me n is descri be d i n Ta ble 2  f or Safet y R u n-i n C o h ort 1 a n d Ta ble 3  f or P hase 2 C o h ort 1.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8 
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 9 8
2 4 Oct o ber 2 0 2 3
A p pe n di x T a ble 2. 
Sc he d ule of Assess me nts – P osttre at me nt
E O T Visit
S afet y F oll o w- u p 
Visit/ C all ( Tele p h o ne) a
Pre- Pr o gressi o n Visit b
S ur vi v al F oll o w- u p
Wit hi n 7 D a ys after L ast 
D ose or E O T Decisi o n
3 0 D a ys
after L ast D ose
After S afet y F oll o w- U p 
U ntil Dise ase 
Pr o gressi o n
E ver y 2 M o nt hs 
After S afet y 
F oll o w- U p
Visit Wi n d o w
± 7 D a ys
± 7 D a ys
± 7 D a ys
Uri ne or ser u m pre g na nc y test c
X
X
X
X
He mat ol o g y d 
X
Ser u m or plas ma c he mistr y 
X
P har mac o ki netics
A nti dr u g a nti b o dies 
Rece pt or occ u pa nc y
Circ ulati n g t u m or D N A
W h ole bl o o d R N A
Ser u m a n d plas ma bi o mar kers
Refer t o A p pe n di x Ta ble 3
T u m or i ma gi n g f or res p o nse assess me nt e
X
X
E C O G
X
Vital si g ns 
X
S y m pt o m- directe d p h ysical e xa mi nati o n
X
A d verse e ve nts f
X
X
C o nc o mita nt me dicati o ns
X
X
Ne w a ntica ncer t hera p y g
X
X
X
S ur vi val f oll o w- u p
E ver y 2 m o nt hs h
C T = c o m p ute d t o m o gra p h y; E C O G = Easter n C o o perati ve O nc ol o g y Gr o u p; E O T = e n d of treat me nt; M RI = ma g netic res o na nce i ma gi n g; T C R = T cell rece pt or

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8 
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 9 9
2 4 Oct o ber 2 0 2 3
a  
If t he patie nt e x perie nces a treat me nt-relate d A E or a n S A E (re gar dless of attri b uti o n), t he patie nt m ust be as ke d t o c o me t o t he site.
b  
T his will o nl y a p pl y f or patie nts w h o st o p st u d y treat me nt n ot relate d t o ra di o gra p hic disease pr o gressi o n a n d will c o nti n ue t o ha ve t u m or i ma gi n g. See f o ot n ote (e) f or details 
o n t u m or i ma gi n g sc he d ule. Pre- pr o gressi o n visits will be c o m plete d first bef ore pr ocee di n g t o s ur vi val f oll o w- u p.
c  
Pre g na nc y testi n g will c o nti n ue m o nt hl y u p t o 6 m o nt hs after t he e n d of treat me nt per t he d urati o n of re q uire d c o ntrace pti o n as disc usse d i n A p pe n di x 6 . Testi n g d uri n g 
s ur vi val f oll o w- u p ma y be d o ne at h o me a n d t he res ult self-re p orte d b y t he patie nt.
d   
A c o m plete bl o o d c o u nt wit h differe ntial, platelets, a n d retic ul oc ytes will be c o n d ucte d.
e  
T u m or i ma gi n g at E O T visit n ot re q uire d if perf or me d wit hi n t he last 3 0 da ys or pr o gressi ve disease has bee n d oc u me nte d. C T/ M RI will be perf or me d per Secti o n 6. 6 . F or 
patie nts w h o st o p st u d y treat me nt n ot relate d t o ra di o gra p hic disease pr o gressi o n (e g, e x perie nce d u ne x pecte d t o xicit y), sca ns s h o ul d c o nti n ue t o be c ollecte d a p pr o xi matel y 
e ver y 9 wee ks ( 2 1- da y d osi n g c ycle) u ntil disease pr o gressi o n or i nitiati o n of s yste mic a ntit u m or t hera p y ot her t ha n t he st u d y treat me nt, w hic he ver is earlier.
f  
Re p ort all A Es t hr o u g h t he Safet y F oll o w- u p Visit/ Call, a n d a n y treat me nt-relate d S A Es t hereafter.
g  
C ollect ne w a ntica ncer t hera p y data f oll o wi n g t he last d ose of st u d y treat me nt u ntil t he e n d of s ur vi val f oll o w- u p.
h  
S ur vi val f oll o w- u p will be c o n d ucte d via a p h o ne call e ver y 2 m o nt hs u ntil deat h or e n d of st u d y. D urati o n of s ur vi val f oll o w- u p will be li mite d t o 3 years.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8 
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 0 0
2 4 Oct o ber 2 0 2 3
A p pe n di x T a ble 3. 
P h ar m ac o ki netic, A nti dr u g A nti b o dies, a n d Bi o m ar ker: Sc he d ule of Assess me nts
C ycle 1 
C ycle 2 
C ycle 3 
C ycle 4 
C ycle 5 
C ycle 7 
C ycle 1 0 
C ycle 1 3 
E O T
C ycle D a y
Scree ni n g
D a y −3 0 
t o −1
1 
8 
1 5 
1 
1 
1 
1 
1 
1 
1
P K a
X 
X
X 
X b
X 
X 
X 
X 
X
A nti dr u g a nti b o dies c
X
X 
X
X 
X 
X 
X 
X
Rece pt or occ u pa nc y d
X 
X 
X
X 
X 
X
X
X
Circ ulati n g t u m or D N A e
X 
X
X
X 
X
X
X
P B M C f
X 
X
X 
X
T C R se q ue nci n g f
X 
X
X 
X
I m m u n o p he n ot y pi n g assa yf
X 
X g
X 
X
Ser u m a n d plas ma bi o mar kers h
X 
X g
X 
X 
X
X
X
W h ole bl o o d R N A
h
X 
X g
X 
X 
X
X
X
St o ol micr o bi o me i
X
X
Ge n o mic bl o o d sa m ple j
X
T u m or bi o ps y
X
X k
A D A = a nti dr u g a nti b o dies; E O T = e n d of treat me nt; P B M C = peri p heral bl o o d m o n o n uclear cell; P K = p har mac o ki netic; R O = rece pt or occ u pa nc y; T C R = T-cell rece pt or
a  
P K sa m ples will be c ollecte d fr o m patie nts w h o are assi g ne d t o recei ve ma gr oli ma b. P K sa m ples are t o be c ollecte d pre d ose wit hi n 1 2 h o urs pri or t o t he first a d mi nistrati o n of 
ma gr oli ma b gi ve n i n C ycles 1, 2, 3, 5, 7, 1 0, 1 3, a n d o n C ycle 1 Da y 8 a n d at t he e n d of treat me nt.
b  
I n C ycle 3, P K sa m ples are t o be c ollecte d pre d ose ( wit hi n 1 2 h o urs) a n d p ost- d ose at 1 h o ur ( ± 1 5 mi n) after t he e n d of t he i nf usi o n of t he first a d mi nistrati o n of ma gr oli ma b 
gi ve n.
c   
A D A sa m ples will be c ollecte d fr o m patie nts w h o are assi g ne d t o recei ve ma gr oli ma b. A D A sa m ples are t o be c ollecte d pri or t o t he a d mi nistrati o n of ma gr oli ma b at t he sa me 
ti me as t he pre d ose P K sa m ples i n C ycles 1, 2, 3, 5, 7, 1 0, 1 3, a n d e n d of treat me nt.
d  
R O sa m ples will be c ollecte d fr o m patie nts w h o are assi g ne d t o recei ve ma gr oli ma b. R O sa m ples are t o be c ollecte d pre d ose wit hi n 1 2 h o urs pri or t o a d mi nistrati o n of 
ma gr oli ma b o n C ycle 1 Da y 1, C ycle 1 Da y 8, a n d C ycle 1 Da y 1 5, pre d ose wit hi n 1 2 h o urs pri or t o t he first a d mi nistrati o n of ma gr oli ma b gi ve n i n C ycles 3, 4, 5, a n d 1 0, 
a n d at e n d of treat me nt, if occ urri n g bef ore C ycle 1 0. R O sa m ples will be c ollecte d at select sites o nl y.
e  
Sa m ples will be c ollecte d at scree ni n g a n d pre d ose wit hi n 1 2 h o urs pri or t o t he a d mi nistrati o n of ma gr oli ma b o n C ycle 1 Da y 1 a n d C ycle 1 Da y 1 5, pre d ose wit hi n 1 2 h o urs 
pri or t o t he first a d mi nistrati o n of ma gr oli ma b gi ve n i n C ycles 3, 4, a n d 7, a n d at e n d of treat me nt (re gar dless of ti me of occ urre nce).
f  
Sa m ples will be c ollecte d pre d ose wit hi n 1 2 h o urs pri or t o a d mi nistrati o n of ma gr oli ma b o n C ycle 1 Da y 1 a n d C ycle 1 Da y 8, a n d pre d ose wit hi n 1 2 h o urs pri or t o t he first 
a d mi nistrati o n of ma gr oli ma b gi ve n i n C ycles 2 a n d 3. P M B C a n d i m m u n o p he n ot y pi n g will be c ollecte d at select sites o nl y.
g  
F or ser u m a n d plas ma bi o mar kers, w h ole bl o o d R N A, a n d i m m u n o p he n ot y pi n g assa y, a n a d diti o nal sa m ple will be c ollecte d 4 h o urs p ost d ose o n C ycle 1 Da y 8.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8 
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 0 1
2 4 Oct o ber 2 0 2 3
h  
Sa m ples will be c ollecte d pre d ose wit hi n 1 2 h o urs pri or t o a d mi nistrati o n of ma gr oli ma b o n C ycle 1 Da y 1 a n d C ycle 1 Da y 8, pre d ose wit hi n 1 2 h o urs pri or t o t he first 
a d mi nistrati o n of ma gr oli ma b gi ve n i n C ycles 2, 3, 4, a n d 7, a n d at e n d of treat me nt if occ urri n g bef ore C ycle 7.
i  
St o ol micr o bi o me t o be c ollecte d pre d ose o n or bef ore C ycle 1 Da y 1 a n d a n yti me wit hi n 7 da ys of C ycle 3 Da y 1.
j  
T he ge n o mic bl o o d sa m ple ca n be c ollecte d at C ycle 1 Da y 1 or at a n y ti me d uri n g t he st u d y.
k   
O n-treat me nt t u m or bi o ps y ca n be c ollecte d a n y ti me bet wee n C ycle 3 Da y 1 a n d C ycle 4 Da y 1.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8 
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 0 2
2 4 Oct o ber 2 0 2 3
A p pe n di x 4.  
P a n de mic Ris k Assess me nt a n d Miti g ati o n Pl a n
D uri n g a n o n g oi n g pa n de mic, p ote ntial ris ks ass ociate d wit h patie nts bei n g u na ble t o atte n d 
st u d y visits ha ve bee n i de ntifie d f or t his st u d y. S pecial pa n de mic meas ures ca n be a p plie d o nl y 
w he n i n acc or da nce wit h t he c urre nt sit uati o n a n d a p plica ble l ocal a ut h orit y re g ulati o ns, 
rec o m me n dati o ns, or si milar.
T hese p ote ntial ris ks a n d miti gati o n pla ns ca n be s u m marize d as f oll o ws:
1)
Sc he d ule of assess me nts:
a)
P h ysical e xa mi nati o n:
i)
I n or der t o li mit a patie nt’s ti me i n t he cli nic, a virt ual visit ma y be c o n d ucte d f or t he 
p h ysical e xa mi nati o n assess me nt. Vital si g ns ma y be o mitte d f or virt ual visits. 
H o we ver, d osi n g a n d bi ol o gical sa m ple c ollecti o n s h o ul d occ ur per pr ot oc ol i n t he 
cli nic.
b)
D osi n g:
i)
Patie nts ma y be u na ble t o ret ur n t o t he site f or a n u m ber of visits t o recei ve t he st u d y 
dr u g, or t he site ma y be u na ble t o acce pt a n y patie nt visits. Wit h o ut st u d y dr u gs, t he 
patie nt w o ul d n ot be a ble t o sta y o n t he st u d y dr u g as pla n ne d per pr ot oc ol.
Miti gati o n pla n: If per mitte d b y l ocal et hics c o m mittee/i nstit uti o nal re vie w b oar ds 
n o n-i n vesti gati o nal pr o d uct as deter mi ne d b y s p o ns or (ie, d oceta xel) ca n be a d mi nistere d 
at a cli nic cl oser t o t he patie nt, u n der t he s u per visi o n of a lice nse d p h ysicia n. If 
necessar y, a d osi n g dela y f or ma gr oli ma b m ust be disc usse d wit h t he s p o ns or i n t his 
i nsta nce. A virt ual st u d y visit, via p h o ne or vi de o c o nfere nci n g, m ust be perf or me d pri or 
t o re m ote d osi n g. At t he earliest o p p ort u nit y, t he site will sc he d ule i n- pers o n patie nt 
visits a n d ret ur n t o t he pr ot oc ol’s re g ular sc he d ule of assess me nts. A q ualifie d c o urier 
ma y be c o nsi dere d t o s hi p t he dr u g fr o m sites t o t he alter nate cli nic.
c)
Ge neral patie nt selecti o n g ui da nce:
i)
T o mi ni mize patie nts recei vi n g re d bl o o d cell tra nsf usi o ns, we rec o m me n d selecti n g 
patie nts wit h hi g her he m o gl o bi n t hres h ol ds at baseli ne a n d use i ntra ve n o us ir o n 
a n d/ or er yt hr o p oieti n w here cli nicall y i n dicate d.
2)
St u d y dr u g s u p plies t o patie nts a n d sites:
a)
S hi p me nts of st u d y dr u g fr o m t he s p o ns or t o t he i n vesti gati o nal site c o ul d be dela ye d 
beca use of tra ns p ortati o n iss ues. Wit h o ut st u d y dr u g, t he patie nt w o ul d n ot be a ble t o sta y 
o n t he st u d y dr u g as pla n ne d per pr ot oc ol.
Miti gati o n pla n: T he sites’ st u d y dr u g i n ve nt or y s h o ul d be cl osel y m o nit ore d. Site staff 
s h o ul d n otif y t he s p o ns or or dele gate if t he y f oresee s h orta ge i n st u d y dr u g i n ve nt or y or if 
t here is a n y i nterr u pti o n i n l ocal s hi p pi n g ser vice. T he s p o ns or will c o nti n ue t o m o nit or 
i n ve nt or y at t he st u d y dr u g de p ot a n d st u d y sites. Ma n ual s hi p me nts will be tri g gere d as 
necessar y.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8 
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 0 3
2 4 Oct o ber 2 0 2 3
3)
Patie nt safet y m o nit ori n g a n d f oll o w- u p:
a)
Patie nts ma y be u na ble or u n willi n g t o c o me t o t he st u d y site f or t heir sc he d ule d st u d y 
visits as re q uire d per pr ot oc ol.
Miti gati o n pla n: F or patie nts w h o ma y be u na ble or u n willi n g t o visit t he st u d y site f or 
t heir sc he d ule d st u d y visits as re q uire d per pr ot oc ol, t he pri nci pal i n vesti gat or or 
q ualifie d dele gate will c o n d uct a virt ual st u d y visit, via p h o ne or vi de o c o nfere nci n g, t o 
assess t he patie nt wit hi n t he tar get visit wi n d o w date w he ne ver p ossi ble. D uri n g t he 
virt ual st u d y visit, t he f oll o wi n g i nf or mati o n at mi ni m u m will be re vie we d:
i) 
C o nfir m if patie nt has e x perie nce d a n y a d verse e ve nts ( A Es)/seri o us a d verse e ve nts 
( S A Es)/s pecial sit uati o ns (i ncl u di n g pre g na nc y) a n d f oll o w- u p o n a n y u nres ol ve d 
A E/ S A Es
ii)
Re vie w c urre nt list of c o nc o mita nt me dicati o ns a n d d oc u me nt a n y ne w c o nc o mita nt 
me dicati o ns
iii) If a p plica ble, c o nfir m t hat patie nt-re p orte d o utc o mes ha ve bee n c o m plete d a n d 
tra ns mitte d w here p ossi ble
b)
Patie nts ma y be u na ble or u n willi n g t o tra vel t o t he site f or pla n ne d assess me nts (e g, 
safet y bl o o d dra ws); he nce, sa m ples ma y n ot be a nal yze d at t he site la b orat or y a n d/ or 
se nt f or ce ntral la b orat or y a nal yses.
Miti gati o n pla n: Accre dite d l ocal la b orat ories t hat are n ot affiliate d wit h t he site ma y be 
utilize d as a p pr o priate t o m o nit or patie nt safet y u ntil t he patie nt ca n ret ur n t o t he site f or 
t heir re g ular f oll o w- u p per pr ot oc ol. A n y la b orat or y assess me nts c o n d ucte d at a l ocal 
la b orat or y d ue t o t he pa n de mic will be d oc u me nte d acc or di n gl y. Pre g na nc y testi n g ma y 
be perf or me d usi n g a h o me uri ne pre g na nc y test if l ocal la b orat or y pre g na nc y testi n g is 
n ot feasi ble. Alter nati ve sa m ple ha n dli n g a n d st ora ge ma y be p ossi ble f or sa m ples 
r o uti nel y se nt t o t he ce ntral la b orat or y, sites s h o ul d refer t o t he st u d y la b orat or y ma n ual 
a n d disc uss wit h t he s p o ns or f or f urt her g ui da nce.
c)
Patie nts ma y be u na ble or u n willi n g t o atte n d t he st u d y visit t o si g n a n u p date d i nf or me d 
c o nse nt f or m versi o n if t here is a n u p date.
Miti gati o n pla n: T he site staff will f oll o w t heir a p pr o ve d c o nse nt pr ocess a n d re mai n i n 
c o m plia nce wit h l ocal E C/I R B a n d nati o nal la ws a n d re g ulati o ns. Re m ote c o nse nt will be 
all o we d if it has bee n a p pr o ve d b y t he l ocal E C/I R B. T he c o nse nt pr ocess will be 
d oc u me nte d a n d c o nfir me d b y n or mal c o nse nt pr oce d ure at t he earliest o p p ort u nit y.
d)
T he safet y of trial patie nts is i m p orta nt a n d testi n g of c or o na vir us disease 2 0 1 9 
( C O VI D- 1 9) i nfecti o n will be base d o n l ocal cli nical g ui deli nes f or testi n g base d o n 
si g ns/s y m pt o ms a n d or s us pecte d e x p os ure t o C O VI D- 1 9.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8 
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 0 4
2 4 Oct o ber 2 0 2 3
Miti gati o n pla n: If patie nt has a dia g n osis of C O VI D- 1 9 w hile o n t his cli nical st u d y, 
st u d y dr u gs ma y be hel d u ntil cli nical i m pr o ve me nt or res ol uti o n i n acc or da nce wit h t he 
treati n g p h ysicia n’s j u d g me nt a n d ge neral ma gr oli ma b d ose dela y g ui da nce i n t he 
pr ot oc ol. A d diti o nal s u p p orti ve care a n d treat me nt meas ures f or C O VI D- 1 9 i nfecti o n o n 
t he st u d y will be perf or me d i n acc or da nce wit h l ocal i nstit uti o nal g ui deli nes. Patie nts 
wit h a C O VI D- 1 9 i nfecti o n w hile partici pati n g i n t he cli nical trial will ha ve t his e ve nt 
d oc u me nte d as a n a d verse e ve nt i n t he cli nical data base.
4)
Pr ot oc ol a n d m o nit ori n g c o m plia nce:
a)
Pr ot oc ol de viati o ns ma y occ ur, i n case sc he d ule d visits ca n n ot occ ur as pla n ne d per 
pr ot oc ol.
Miti gati o n pla n: If it is n ot p ossi ble t o c o m plete a re q uire d pr oce d ure, a n u nsc he d ule d 
visit s h o ul d be c o n d ucte d as s o o n as p ossi ble w he n c o n diti o ns all o w. T he sit uati o n s h o ul d 
be rec or de d a n d e x plai ne d as a pr ot oc ol de viati o n. A n y misse d patie nt visits or de viati o n 
t o t he pr ot oc ol d ue t o t he pa n de mic m ust be re p orte d i n t he electr o nic case re p ort f or m 
a n d descri be d i n t he cli nical st u d y re p ort. A n y virt ual st u d y visits t hat are c o n d ucte d i n 
lie u of cli nic visits d ue t o t he pa n de mic will be d oc u me nte d as a pr ot oc ol de viati o n 
relate d t o t he pa n de mic.
b) 
M o nit ors ma y be u na ble t o carr y o ut s o urce data re vie w, s o urce data verificati o n, or st u d y 
dr u g acc o u nta bilit y or assess pr ot oc ol a n d G o o d Cli nical Practice c o m plia nce. T his ma y 
lea d t o dela ys i n s o urce data verificati o n, a n i ncrease i n pr ot oc ol de viati o ns, or u n der 
re p orti n g of A Es.
Miti gati o n pla n: T he st u d y m o nit or is t o re mai n i n cl ose c o m m u nicati o n wit h t he site t o 
e ns ure data e ntr y a n d q uer y res ol uti o n. T he st u d y m o nit or is t o refere nce t he St u d y 
M o nit ori n g Pla n f or g ui da nce o n h o w t o c o n d uct a re m ote m o nit ori n g visit. T he st u d y 
staff is t o sa ve a n d d oc u me nt all rele va nt c o m m u nicati o n i n t he st u d y files. T he stat us of 
sites t hat ca n n ot acce pt m o nit ori n g visits a n d/ or patie nts o n site m ust be trac ke d ce ntrall y 
a n d u p date d o n a re g ular basis.
5) 
Missi n g data a n d data i nte grit y:
a)
T here ma y be a n i ncrease d a m o u nt of missi n g data d ue t o patie nts missi n g 
visits/assess me nts. T his c o ul d ha ve a n i m pact o n t he a nal ysis a n d t he i nter pretati o n of 
cli nical st u d y data.
Miti gati o n pla n: I m plicati o ns of a pa n de mic o n met h o d ol o gical as pects f or t he st u d y will 
be t h or o u g hl y assesse d a n d d oc u me nte d, a n d rele va nt acti o ns will be ta ke n as a p pr o priate 
(ie, m o dificati o n of t he statistical a nal ysis pla n) a n d i n c o m plia nce wit h re g ulat or y 
a ut h orities’ g ui da nce. O verall, t he cli nical st u d y re p ort will descri be t he i m pact of t he 
pa n de mic o n t he i nter preta bilit y of st u d y data.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8 
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 0 5
2 4 Oct o ber 2 0 2 3
Ris ks will be assesse d c o nti n u o usl y, a n d te m p orar y meas ures will be i m ple me nte d t o miti gate 
t hese ris ks as part of a miti gati o n pla n, as descri be d a b o ve. T hese meas ures will be 
c o m m u nicate d t o t he rele va nt sta ke h ol ders as a p pr o priate a n d are i nte n de d t o pr o vi de alter nati ve 
met h o ds t hat will e ns ure t he e val uati o n a n d assess me nt of t he safet y of patie nts w h o are e nr olle d 
i n t his st u d y.
Si nce t hese p ote ntial ris ks are c o nsi dere d miti gate d wit h t he i m ple me ntati o n of t hese meas ures, 
t he e x pecte d be nefit-ris k assess me nt of ma gr oli ma b i n st u d y patie nts re mai ns u nc ha n ge d. I n case 
of a n i ncrease i n t hese p ote ntial ris ks, w hic h ca n n ot be miti gate d d ue t o t he escalati o n of a 
pa n de mic, e nr oll me nt of ne w patie nts will be place d o n h ol d u ntil t he pa n de mic o ut brea k is 
u n der c o ntr ol b y f oll o wi n g l ocal re g ulat or y g ui deli nes.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8 
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 0 6
2 4 Oct o ber 2 0 2 3
A p pe n di x 5.  
T o xicit y Gr a di n g Sc ale f or Se verit y of A d verse E ve nts a n d 
L a b or at or y A b n or m alities
htt ps://cte p.ca ncer. g o v/ pr ot oc ol De vel o p me nt/electr o nic _a p plicati o ns/ d ocs/ C T C A E _ v 5 _ Q uic k _ R 
efere nce _ 8. 5 x 1 1. p df

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8 
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 0 7
2 4 Oct o ber 2 0 2 3
A p pe n di x 6.  
Pre g n a nc y Prec a uti o ns, Defi niti o n f or Fe m ale of C hil d be ari n g 
P ote nti al, a n d C o ntr ace pti ve Re q uire me nts
1)   
Defi niti o ns
a.   
Defi niti o n of C hil d be ari n g P ote nti al
F or t he p ur p oses of t his st u d y, a fe male- b or n patie nt is c o nsi dere d of c hil d beari n g p ote ntial 
f oll o wi n g t he i nitiati o n of p u bert y ( Ta n ner sta ge 2) u ntil bec o mi n g p ost me n o pa usal, u nless t he 
patie nt is per ma ne ntl y sterile or has me dicall y d oc u me nte d o varia n fail ure.
W o me n are c o nsi dere d t o be i n a p ost me n o pa usal state w he n t he y are ≥ 5 4 years of a ge wit h 
cessati o n of pre vi o usl y occ urri n g me nses f or ≥ 1 2 m o nt hs wit h o ut a n alter nati ve ca use. I n 
a d diti o n, w o me n of < 5 4 years of a ge wit h a me n orr hea of ≥ 1 2 m o nt hs ma y als o be c o nsi dere d 
p ost me n o pa usal if t heir f ollicle-sti m ulati n g h or m o ne le vel is i n t he p ost me n o pa usal ra n ge a n d 
t he y are n ot usi n g h or m o nal c o ntrace pti o n or h or m o nal re place me nt t hera p y.
Per ma ne nt sterilizati o n i ncl u des h ysterect o m y, bilateral o o p h orect o m y, or bilateral 
sal pi n gect o m y i n a fe male patie nt of a n y a ge.
b.   
Defi niti o n of M ale Fertilit y
F or t he p ur p oses of t his st u d y, a male- b or n patie nt is c o nsi dere d fertile after t he i nitiati o n of 
p u bert y u nless t he patie nt is per ma ne ntl y sterile b y bilateral orc hi dect o m y or me dical d oc u me ntati o n.
2)   
C o ntr ace pti o n Re q uire me nts f or Fe m ale P atie nts
a.  
St u d y Dr u g Effects o n Pre g n a nc y a n d H or m o n al C o ntr ace pti o n
Ma gr oli ma b is c o ntrai n dicate d i n pre g na nc y as a hi g her i nci de nce of t otal pre g na nc y l oss has 
bee n o bser ve d i n a n e m br y ofetal de vel o p me nt t o xicit y st u d y i n c y n o m ol g us m o n ke ys a n d t here 
is a str o n g s us pici o n of h u ma n fet ot o xicit y i n earl y pre g na nc y base d o n t he n o ncli nical data. F or 
ma gr oli ma b, t here is n o a ntici pate d p har mac o ki netic i nteracti o n wit h pr o gesti n or ot her ster oi ds 
base d o n t he disti nct cleara nce pat h wa ys.
Base d o n t he mec ha nis m of acti o n ( M O A) a n d fi n di n gs i n a ni mals, d oceta xel ca n ca use fetal 
har m w he n a d mi nistere d t o a pre g na nt w o ma n. W o me n of c hil d beari n g p ote ntial s h o ul d be 
a d vise d t o use effecti ve c o ntrace pti o n a n d a v oi d bec o mi n g pre g na nt d uri n g t hera p y wit h 
d oceta xel. If t he patie nt bec o mes pre g na nt w hile recei vi n g d oceta xel, t he patie nt s h o ul d be 
a p prise d of t he p ote ntial hazar d t o t he fet us. T here is n o c o ntrai n dicati o n t o h or m o nal 
c o ntrace pti o n acc or di n g t o t he d oceta xel prescri bi n g i nf or mati o n.
b.   
C o ntr ace pti o n Re q uire me nts f or Fe m ale P atie nts of C hil d be ari n g P ote nti al
T he i ncl usi o n of fe male patie nts of c hil d beari n g p ote ntial re q uires t he use of hi g hl y effecti ve 
c o ntrace pti ve meas ures wit h a fail ure rate of < 1 % per year. T he y m ust ha ve a ne gati ve ser u m 
pre g na nc y test at scree ni n g a n d a ne gati ve pre g na nc y test is re q uire d pri or t o st u d y treat me nt 
a d mi nistrati o n o n C ycle 1 Da y 1. T he C ycle 1 Da y 1 pre g na nc y test d oes n ot nee d t o be re peate d 
if t he scree ni n g pre g na nc y test was perf or me d wit hi n t he 7 2 h o urs bef ore st u d y treat me nt 
a d mi nistrati o n. Pre g na nc y tests will be perf or me d at t he be gi n ni n g of eac h c ycle t hereafter 
( descri be d i n t he pr ot oc ol), a n d c o nti n ue m o nt hl y u p t o 6 m o nt hs after t he e n d of treat me nt per 
t he d urati o n of re q uire d c o ntrace pti o n.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8 
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 0 8
2 4 Oct o ber 2 0 2 3
D urati o n of re q uire d c o ntrace pti o n f or fe male patie nts i n t his cli nical trial s h o ul d start fr o m 
Scree ni n g visit u ntil 6 m o nt hs after last d ose of t he latest a d mi nistere d st u d y dr u g.
Fe male patie nts m ust a gree t o o ne of t he f oll o wi n g c o ntrace pti ve met h o ds:
C o m plete a bsti ne nce fr o m i nterc o urse of re pr o d ucti ve p ote ntial. A bsti ne nce is a n acce pta ble 
met h o d of c o ntrace pti o n o nl y w he n it is i n li ne wit h t he patie nt’s preferre d a n d us ual lifest yle.
Or
•
C o nsiste nt a n d c orrect use of 1 of t he f oll o wi n g met h o ds of birt h c o ntr ol liste d bel o w:

N o n- h or m o nal i ntra uteri ne de vice (I U D)

H or m o nal I U D ( m ust be use d i n c o nj u ncti o n wit h a barrier met h o d)

Bilateral t u bal occl usi o n ( u p o n me dical assess me nt of s ur gical s uccess)

Vasect o m y i n t he male part ner ( u p o n me dical assess me nt of s ur gical s uccess)
Or
Fe male patie nts w h o wis h t o use a h or m o nall y base d met h o d m ust use it i n c o nj u ncti o n wit h a 
barrier met h o d, prefera bl y a male c o n d o m. H or m o nal met h o ds are restricte d t o t h ose ass ociate d 
wit h t he i n hi biti o n of o v ulati o n. H or m o nall y base d c o ntrace pti ves a n d barrier met h o ds per mitte d 
f or use i n t his pr ot oc ol are as f oll o ws:
•
H or m o nal met h o ds (eac h met h o d m ust be use d wit h a barrier met h o d, prefera bl y male 
c o n d o m)

Oral c o ntrace pti ves (eit her c o m bi ne d or pr o gester o ne o nl y)

I njecta ble pr o gester o ne

Tra ns der mal c o ntrace pti ve patc h

C o ntrace pti ve va gi nal ri n g

S u b der mal c o ntrace pti ve i m pla nt
•
Barrier met h o ds (eac h met h o d m ust be use d wit h a h or m o nal met h o d)

Male c o n d o m ( wit h or wit h o ut s per mici de)

Fe male c o n d o m ( wit h or wit h o ut s per mici de)

Dia p hra g m wit h s per mici de

Cer vical ca p wit h s per mici de

S p o n ge wit h s per mici de

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8 
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 0 9
2 4 Oct o ber 2 0 2 3
I ncl usi o n of met h o ds of c o ntrace pti o n i n t his list of per mitte d met h o ds d oes n ot i m pl y t hat t he 
met h o d is a p pr o ve d i n a n y c o u ntr y or re gi o n. Met h o ds s h o ul d o nl y be use d if l ocall y a p pr o ve d.
Fe male patie nts m ust als o refrai n fr o m e g g d o nati o n, cr y o preser vati o n of cells, a n d i n vitr o 
fertilizati o n d uri n g treat me nt a n d u ntil t he e n d of c o ntrace pti o n re q uire me nt. If nee de d, fe male 
patie nts s h o ul d be a d vise d t o see k a d vice a b o ut e g g d o nati o n a n d cr y o preser vati o n pri or t o 
treat me nt.
3)   
C o ntr ace pti o n Re q uire me nts f or M ale P atie nts
It is t he oreticall y p ossi ble t hat a rele va nt s yste mic c o nce ntrati o n of st u d y dr u g ma y be ac hie ve d 
i n a fe male part ner fr o m e x p os ure t o t he patie nt’s se mi nal fl ui d a n d p ose a p ote ntial ris k t o a n 
e m br y o/fet us. Male patie nts wit h fe male part ners of c hil d beari n g p ote ntial m ust use c o n d o ms 
d uri n g treat me nt a n d u ntil 6 m o nt hs after last d ose of t he latest a d mi nistere d st u d y dr u g. If t he 
fe male part ner of c hil d beari n g p ote ntial is n ot pre g na nt, use of a n y hi g hl y effecti ve l ocall y 
a p pr o ve d c o ntrace pti ve meas ure s h o ul d als o be c o nsi dere d.
Male patie nts m ust als o refrai n fr o m s per m d o nati o n a n d cr y o preser vati o n of cells d uri n g 
treat me nt a n d u ntil t he e n d of c o ntrace pti o n re q uire me nt. If nee de d, male patie nts s h o ul d be 
a d vise d t o see k a d vice a b o ut s per m d o nati o n a n d cr y o preser vati o n pri or t o treat me nt.
4)   
U n acce pt a ble Birt h C o ntr ol Met h o ds
Birt h c o ntr ol met h o ds t hat are u nacce pta ble i ncl u de peri o dic a bsti ne nce (e g, cale n dar, o v ulati o n, 
s y m pt ot her mal, p ost o v ulati o n met h o ds), wit h dra wal (c oit us i nterr u pt us), s per mici des o nl y, a n d 
lactati o nal a me n orr hea met h o d. A fe male c o n d o m a n d a male c o n d o m s h o ul d n ot be use d 
t o get her.
5)  
Pr oce d ures t o be F oll o we d i n t he E ve nt of Pre g n a nc y
Fe male patie nts will be i nstr ucte d t o n otif y t he i n vesti gat or if t he y bec o me pre g na nt or s us pect 
t he y are pre g na nt at a n y ti me fr o m start of t he st u d y t o 6 m o nt hs after last st u d y dr u g d ose. St u d y 
dr u g m ust be disc o nti n ue d i m me diatel y.
Male patie nts w h ose part ner has bec o me pre g na nt or s us pects s he is pre g na nt fr o m start of st u d y 
t o 6 m o nt hs after last st u d y dr u g d ose m ust als o re p ort t he i nf or mati o n t o t he i n vesti gat or. 
Part ner pre g na nc y i nf or mati o n will n ot be c ollecte d i n t his st u d y; h o we ver, t he i n vesti gat or 
s h o ul d rei nf orce pr o per c o ntrace pti o n use wit h t he st u d y patie nt if a part ner pre g na nc y is 
re p orte d. I nstr ucti o ns f or re p orti n g pre g na nc y a n d pre g na nc y o utc o me are o utli ne d i n 
Secti o n 7. 4. 2. 3 .

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8 
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 1 0
2 4 Oct o ber 2 0 2 3
A p pe n di x 7.  
E aster n C o o per ati ve O nc ol o g y Gr o u p ( E C O G) Perf or m a nce St at us
Gr a de
0
F ull y acti ve, a ble t o carr y o n all pre- disease perf or ma nce wit h o ut restricti o n
1
Restricte d i n p h ysicall y stre n u o us acti vit y b ut a m b ulat or y a n d a ble t o carr y o ut w or k of a li g ht 
or se de ntar y nat ure (e g, li g ht h o use w or k, office w or k)
2
A m b ulat or y a n d ca pa ble of all self-care b ut u na ble t o carr y o ut a n y w or k acti vities.
U p a n d a b o ut m ore t ha n 5 0 % of wa ki n g h o urs
3
Ca pa ble of o nl y li mite d self-care, c o nfi ne d t o be d or c hair m ore t ha n 5 0 % of wa ki n g h o urs
4
C o m pletel y disa ble d. Ca n n ot carr y o n a n y self-care. T otall y c o nfi ne d t o be d or c hair.
5
Dea d
{ O ke n 1 9 8 2 }

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8 
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 1 1
2 4 Oct o ber 2 0 2 3
A p pe n di x 8.   
Res p o nse E v al u ati o n Criteri a i n S oli d T u m ors ( R E CI S T, Versi o n 1. 1)
Eise n ha uer E A, T herasse P, B o gaerts J, Sc h wartz L H, Sar ge nt D, F or d R, et al. Ne w res p o nse 
e val uati o n criteria i n s oli d t u m o urs: re vise d R E CI S T g ui deli ne ( Versi o n 1. 1). E ur 
J C a ncer. 2 0 0 9; 4 5: 2 2 8- 2 4 7 f or f ull R E CI S T g ui deli nes.

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8 
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 1 2
2 4 Oct o ber 2 0 2 3
A p pe n di x 9.   
C o u ntr y- S pecific Re q uire me nts
N ot a p plica ble. 

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8 
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 1 3
2 4 Oct o ber 2 0 2 3
A p pe n di x 1 0.   
A me n d me nt Hist or y
Hi g h-le vel s u m maries of t he hist or y of t his st u d y’s a me n d me nts are pr o vi de d i n ta b ular f or m i n 
t he s u bsecti o ns bel o w (fr o m m ost rece nt a me n d me nt t o ol dest), wit h c ha n ges liste d i n eac h ta ble 
i n or der of i m p orta nce. Mi n or c ha n ges s uc h as t he c orrecti o n of t y p o gra p hic err ors, gra m mar, or 
f or matti n g are n ot detaile d.
Se parate s u m mar y of c ha n ge d oc u me nts f or earlier a me n d me nts are a vaila ble u p o n re q uest.
A se parate trac ke d c ha n ge (re d-li ne d) d oc u me nt c o m pari n g A me n d me nt 4 t o t his a me n d me nt 
will be ma de a vaila ble u p o n t he p u blicati o n of t his pr ot oc ol.
A me n d me nt 5 ( 2 4 Oct o ber 2 0 2 3)
R ati o n ale f or Ke y C h a n ges I ncl u de d i n A me n d me nt 5
Affecte d Secti o ns
C ollecti o n peri o d f or treat me nt-e mer ge nt a d verse e ve nts clarifie d.
Secti o n 8. 6. 4
C ollecti o n peri o d f or i nci de nce of treat me nt-e mer ge nt la b orat or y a b n or malities 
clarifie d. 
Secti o n 8. 6. 5
U p dates ma de t o ali g n wit h c urre nt safet y rec o m me n dati o ns. 
Secti o ns 1. 2. 3, 1. 7, 5. 6 
Ti mi n g of pri mar y a nal ysis f or P hase 2 C o h ort 1 clarifie d. 
Secti o n 8. 2. 2
U p date d t he t o xicit y ma na ge me nt re gar di n g he m o gl o bi n m o nit ori n g t o ali g n 
wit h c urre nt rec o m me n dati o ns. 
Secti o n 7. 8. 1
Re m o ve circ ulati n g t u m or cell sa m ple c ollecti o n as n ot perf or me d.
Secti o n 3. 8; A p pe n di x 
Ta bles 1 a n d 2
Sa m ple size f or ur ot helial ca ncer c o h ort u p date d. 
S y n o psis; Sc he ma; 
Secti o ns 3. 1, 4. 1, a n d 8. 1 0
Ma gr oli ma b a d mi nistrati o n la n g ua ge u p date d t o clarif y vital si g ns will be 
assesse d pri or t o a d mi nistrati o n. 
Secti o ns 5. 4
La n g ua ge a d de d t o all o w l ocal s o urci n g of d oceta xel.
Secti o n 5. 3. 2
U p date d g ui da nce pr o vi de d f or t he ma na ge me nt of i nf usi o n-relate d reacti o ns. 
Secti o n 7. 8. 1. 2 ( Ta ble 1 1)
Ne w secti o ns pr o vi de d f or g ui da nce o n ma na ge me nt of se vere ne utr o pe nia a n d 
seri o us i nfecti o ns.
Secti o ns 7. 8. 1. 5 a n d 7. 8. 1. 6
Te xt a d de d t o ali g n wit h E U- C T R re q uire me nts. 
Secti o ns 1. 4, 7. 2. 1, a n d 9. 2. 2; 
A p pe n dices 2 a n d 9
Te xt u p date d t o clarif y t hat ‘ uri ne or ser u m pre g na nc y tests will be c o n d ucte d 
fr o m C ycle 1 Da y 1’ wit h res pect t o pre g na nc y test.
A p pe n di x Ta ble 1 – 
f o ot n ote ‘e’ a n d A p pe n di x 
Ta ble 2
A nal ysis sets u p date d.
Secti o n 8. 3
G ui da nce o n C O VI D- 1 9 vacci nati o n pr o vi de d.
Secti o n 5. 7. 1. 1
La n g ua ge u p date d t o clarif y t hat a fi nal a nal ysis ma y be c o n d ucte d after t he 
pri mar y a nal ysis.
Secti o n 8. 2. 3
I ncl usi o n criteria were u p date d f or clarificati o n. 
S y n o psis; Secti o n 4. 2
Te xt was u p date d t o re place ‘ partici pa nts’ wit h ‘ patie nts’ t o mai ntai n 
c o nsiste nc y. 
A p pe n di x 3

Ma gr oli ma b
Pr ot oc ol G S- U S- 5 4 8- 5 9 1 8 
Gilea d Scie nces, I nc.
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 1 4
2 4 Oct o ber 2 0 2 3
R ati o n ale f or Ke y C h a n ges I ncl u de d i n A me n d me nt 5
Affecte d Secti o ns
C ha n ges fr o m a d mi nistrati ve a me n d me nt 1 were a d de d t o t he pr ot oc ol.
Secti o n 6. 2. 1
C ha n ges fr o m a d mi nistrati ve a me n d me nt 2 were a d de d t o t he pr ot oc ol.
S y n o psis; Secti o n 6. 6; 
A p pe n di x Ta bles 1 a n d 2 
Mi n or c ha n ges t o c orrect t y p o gra p hic err ors.
T hr o u g h o ut, as nee de d

pr ot  G S- U S- 5 4 8- 5 9 1 8  a m d- 5
E L E C T R O NI C  SI G N A T U R E S
Si g n e d  b y
M e a ni n g  of  Si g n at ur e 
S er v er  D at e
( d d- M M M-
y y y y  h h: m m: s s)
Cli ni c al  D e v el o p m e nt
e Si g n e d
2 5- O ct- 2 0 2 3
1 5: 2 8: 2 8
P P D