Clinical trial NCT02310464
Conditions: Metastatic Gastric Cancer Metastatic Breast Cancer Metastatic Colorectal Cancer Metastatic Lung Cancer
Sponsor: OBI Pharma, Inc
Start date: 2015-12-22; Completion date: 2021-02-02
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this clinical study is to assess the safety and tolerability and efficacy of active immunotherapy with dose escalation and cohort expansion of OBI-833 in advanced/metastatic gastric, lung, colorectal, or breast cancer subjects.

Detailed description:

Arms: arm 1: Each subject will be given a total of 10 doses of OBI-833/OBI-821 subcutaneously at weeks 1,2,3,4,6,8,12,16,20,and 24 (Visits 1,2,3,4,5,6,7,8,9 and 10, respectively). Post treatment, subjects will be continually evaluated for safety and immune response every 4 weeks until the end of study, which is 12 weeks after the last dose, i.e., week 36. Subsequently, subjects will be followed for survival every 8 weeks up to 12 months after the end of study. arm 2: Each subject will be given OBI-833/OBI-821 at Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, and every 8 weeks thereafter (Visits 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and every 8 weeks thereafter) until disease progression. For the subjects discontinued treatment because of disease progression, subjects will be continually evaluated for safety and immune response every 8 weeks until the end of the study, which is 24 weeks after the last dose.
Interventions: intervention 1: OBI-833/OBI-821
Intervention descriptions: intervention 1: None

Protocol documents:
Prot_000.pdf: 
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CLINICAL PROTOCOL
An Open-Label Study to Assess the Safety,
Tolerability, and Efficacy of Active Immunotherapy 
with Dose Escalation and Cohort Expansion of OBI-
833 (Globo H-CRM197) in Advanced/Metastatic
Gastric, Lung, Colorectal, or Breast Cancer
Subjects
Product Name:
OBI-833/OBI-821
Protocol Number:
OBI-833-001
Protocol Version:
Version 10.3 – 30/Jul/2020 (US and Taiwan)
US IND Number: 
16138
Sponsor:
OBI Pharma, Inc.
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LIST OF TABLES
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SYNOPSIS
Name of Company:
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Name of Compound:
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2%,*ORER+&50DQG2%,$GMXYDQW
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Study Title:
$Q2SHQ/DEHO6WXG\WR$VVHVVWKH6DIHW\7ROHUDELOLW\DQG(IILFDF\RI
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Dose Groups and
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Route of 
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Dose Limiting 
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Exclusion Criteria
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3
ELIGIBILITY CRITERIA
3.1
Inclusion Criteria
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 [Dose Escalation Phase]
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3.2
Exclusion Criteria
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4
TREATMENT PLAN
4.1
Subject Enrollment and Dose Escalation Procedure
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STUDY PROCEDURES 
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Treatment Period: Week 6 to Week 24 (Visit 5 to Visit 10) or Disease 
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Table 1
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Time and Event Schedule for Dose Escalation Phase (Continued)
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Table 2
Time and Event Schedule for Cohort Expansion Phase
Phases
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Time and Event Schedule for Cohort Expansion Phase (Continued)
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6
MANAGEMENT OF TOXICITY AND TREATMENT 
DISCONTINUATION
6.1
General Management
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6.4
Guidelines for Individual Subject Study Treatment (OBI-833/OBI-821)
Discontinuation
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7
TREATMENTS PERMITTED AND PROHIBITED DURING STUDY
7.1
Permitted Treatments during Study
[Dose Escalation Phase]
 $QDOJHVLFV 1RQVWHURLGDO DQWLLQIODPPDWRU\ GUXJV 16$,' DQDOJHVLFV RWKHU WKDQ
16$,'OLNHDVSLULQDQGRSLDWHVPD\EHXVHGIRUSDLQFRQWURO
 *&6)DQG+HPDWRSRLHWLFJURZWKIDFWRUVZLOOEHDOORZHGin the dose escalation phase if 
deemed necessary by physicians
 $QWLKLVWDPLQH + DQG + DQG GHFRQJHVWDQW FHWLUL]LQH +&O IH[RIHQDGLQH +&O
OHYRFHWLUL]LQHDQGSVHXGRHSKHGULQH
 $QWLHPHWLFDQGDQWLSUXULWLFVWKHUDS\
 7KHUDS\ZLWKELVSKRVSKRQDWHVHJWRWUHDWERQHPHWDVWDVHVLVDWWKHGLVFUHWLRQRIWKH
LQYHVWLJDWRU
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[Cohort Expansion Phase]
 $QDOJHVLFV1RQVWHURLGDODQWLLQIODPPDWRU\GUXJV16$,'DQDOJHVLFVRWKHUWKDQ
16$,'OLNHDVSLULQDQGRSLDWHVPD\EHXVHGIRUSDLQFRQWURO
 $QWLKLVWDPLQH+DQG+DQGGHFRQJHVWDQWGLSKHQK\GUDPLQHK\GUR[\]LQH
FLPHWLGLQHUDQLWLGLQHIDPRWLGLQHFHWLUL]LQH+&OIH[RIHQDGLQH+&OOHYRFHWLUL]LQHDQG
SVHXGRHSKHGULQH
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LQYHVWLJDWRU
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7.2
Prohibited Treatments during Study
7KHIROORZLQJWUHDWPHQWVDUHSURKLELWHGGXULQJWKH7UHDWPHQWDQG3RVWWUHDWPHQWSHULRGVRIWKH
VWXG\XQWLO(QGRI6WXG\$SSHQGL[,,
[Dose Escalation Phase]
 $QWLFDQFHUWUHDWPHQWQRRWKHUDQWLFDQFHUWKHUDS\LVDOORZHGGXULQJWKHVWXG\7KHOLVWRI
RWKHUFKHPRWKHUDS\DJHQWVFKHPRWKHUDSHXWLFDJHQWVDFWLYHRUSDVVLYHLPPXQRWKHUDS\
LQFOXGHVEXWLVQRWOLPLWHGWR
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HSLSRGRSK\OORWR[LQVWD[DQHVFDPSWRWKHFLQVDQWLWXPRUDQWLELRWLFVQLWURVRXUHDV
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 ,PPXQRWKHUDS\
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 7\URVLQHNLQDVHLQKLELWRUV
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[Cohort Expansion Phase]
 $QWLFDQFHUWUHDWPHQW7KHOLVWRIFKHPRWKHUDS\DJHQWVDFWLYHRUSDVVLYHLPPXQRWKHUDS\
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8
INVESTIGATIONAL DRUG INFORMATION
8.1
OBI-833 (Globo H-CRM197) 
Formulation: 
2%, LV VXSSOLHG DV D VWHULOH O\RSKLOL]HG SRZGHU GUXJ SURGXFW LQ VLQJOHXVH  P/ DPEHU
ERURVLOLFDWHJODVVVHUXPYLDOV(DFKYLDOFRQWDLQVJ*ORER+OLQNHGZLWK&50DORQJ
ZLWKSRWDVVLXPSKRVSKDWHEXIIHUHGVDOLQH6XFURVHDQGSRO\VRUEDWH.
7KH SK\VLFDO DSSHDUDQFH VSHFLILFDWLRQ IRU WKH GUXJ SURGXFW LV O\RSKLOL]HG FDNHSRZGHU 7KH
UHFRQVWLWXWHGVROXWLRQRI2%,GUXJSURGXFWLVDFOHDUOLTXLG
Supplier: 
2%,ZLOOEHVXSSOLHGE\2%,3KDUPD,QF
Source and Pharmacology:
2%, LV D JO\FRFRQMXJDWH FRPSULVHG RI D FDUERK\GUDWH WXPRU DQWLJHQ *ORER + ZKLFK LV
FRYDOHQWO\OLQNHGWRWKHFDUULHUSURWHLQDQLQDFWLYHDQGQRQWR[LFIRUPRIGLSKWKHULDWR[LQ'7
FDOOHGFURVVUHDFWLQJPDWHULDO&50
,PPXQL]DWLRQRIPLFHZLWK*ORER+&50'7LQGXFHGDQWLERGLHVUHDFWLYHZLWK*ORER+
66($DQG66($VXJJHVWLQJWKDWD*ORER+EDVHGYDFFLQHZLOOWDUJHWWXPRUFHOOVH[SUHVVLQJ
*ORER+66($DQG66($0RUHVSHFLILFDOO\DV*ORER+66($DQG66($DUHIRXQG
WREHH[SUHVVHGLQKXPDQWLVVXHVRIEUHDVWFDQFHUKHSDWRFHOOXODUFDQFHU+&&OXQJFDQFHURUDO
FDQFHUJDVWULFDQGSDQFUHDWLFFDQFHUVLWLVSRVWXODWHGWKDWWKHDQWL*ORER+66($DQG66($
 DQWLERGLHV JHQHUDWHG IURP LPPXQL]DWLRQ RI 2%,2%, FDQ WDUJHW WXPRU FHOOV LQ
DIRUHPHQWLRQHGFDQFHUW\SHV
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8.2
OBI-821
Formulation: 
2%, LV O\RSKLOL]HG SRZGHUFDNH LQ LQGLYLGXDO  P/ DPEHU ERURVLOLFDWH JODVV VHUXP YLDO
FRQWDLQLQJJ2%,VRGLXPSKRVSKDWHEXIIHUHGVDOLQHDQG7UHKDORVH
Supplier: 
2%,ZLOOEHVXSSOLHGE\2%,3KDUPD,QF
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2%,3KDUPD,QF
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3DJHRI
Source and Pharmacology:
2%,LVDVDSRQLQEDVHGDGMXYDQWGHULYHGIURPWKHEDUNRIWKHQuillaja saponaria 0ROLQDWUHH
2%,LVDSXULILHGVDSRQLQZKLFKLVVWUXFWXUDOO\VLPLODUWRGHVFULSWLRQVIRXQGLQWKHOLWHUDWXUH
IRUDQRWKHUDGMXYDQW462%,H[LVWVDVDPL[WXUHRILVRPHUV7KHSULPDU\FRPSRQHQWLV
GHVLJQDWHGDV2%,9$ZLWKWKHEDODQFHEHLQJDJURXSRIFORVHO\UHODWHGDQDORJV
2%,KDVEHHQVKRZQWRVWLPXODWHDYDULHW\RILPPXQRORJLFDODFWLYLWLHVLQFOXGLQJDQWLJHQ
VSHFLILFDQWLERG\WRFDUERK\GUDWHWXPRUDQWLJHQFRQMXJDWHGWRDFDUULHUSURWHLQ2%,DOVR
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O\PSKRF\WHVWRVXEXQLWDQWLJHQYDFFLQHVDVZHOODVDQWLJHQVSHFLILFFHOOXODUSUROLIHUDWLRQ
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8.3
Clinical Trial Material (CTM) Supply, Packaging, Labeling and Storage 
$OO&70ZLOOEHVXSSOLHGE\2%,3KDUPDDQGPXVWUHPDLQXQGHUDGHTXDWHVHFXULW\VWRUDJH
FRQGLWLRQ'RQRWXVHDQ\&70DIWHUWKHH[SLUDWLRQGDWHZKLFKLVODEHOHGRQWKHLQYHVWLJDWLRQDO
GUXJFRQWDLQHU
Investigational Drug Supply
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2%,HTXLYDOHQW WR ȝJ*ORER+ DQG 2%, ȝJ DUHSURYLGHGLQ VHSDUDWH
VLQJOHXVHYLDOV2%,LVPL[HGZLWK2%,DWWKHWLPHRIHDFKLQMHFWLRQZLWKLQKRXUV
DIWHU PL[LQJ )ROORZLQJ WKH LQMHFWLRQV WKH OHIWRYHU 2%,2%, PL[WXUHV DUH QRW
UHF\FODEOH
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JRUJRI*ORER+HTXLYDOHQWV2%,GUXJSURGXFWLVUHFRQVWLWXWHGLQZDWHUDQG
PL[HG ZLWK UHFRQVWLWXWHG 2%, LPPHGLDWHO\ 7KH IUHVKO\ FRPELQHG 2%,2%,
PL[WXUHLVDGPLQLVWHUHGE\VXEFXWDQHRXVLQMHFWLRQ6HH$SSHQGL[,IRUGHWDLOHGSURFHGXUHIRU
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Packaging and Labeling 
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Investigational Drug Storage  
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2%,DQG2%,DUHSURYLGHGLQVHSDUDWHVLQJOHXVHYLDOV2%,LVWREHPL[HGZLWK
2%,DWWLPHRILQMHFWLRQV7KHUHFRPPHQGHGVWRUDJHWHPSHUDWXUHIRUERWK2%,DQG
2%,GUXJSURGXFWYLDOVDUHEHWZHHQ±&
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9
STUDY ENDPOINT 
9.1
Primary Endpoints
7KHSULPDU\HQGSRLQWLVVDIHW\DQGWROHUDELOLW\RI2%,2%,DVVHVVHGE\DGYHUVHHYHQWV
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9.2
Secondary Endpoints
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x
7XPRUUHVSRQVHSHU5(&,67FULWHULD
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9.3
Safety Assessment  
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GRVHVRI2%,2%,LPPXQL]DWLRQ
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UHFHLYHGDQGRQDOOVXEMHFWVZKRUHFHLYHGDWOHDVWRQHGRVHRI2%,2%,(YHU\HIIRUW
VKRXOGEHPDGHWRIROORZXSDOOVXEMHFWVDQGDOOVFKHGXOHGHYDOXDWLRQVVKRXOGEHSHUIRUPHG
XQWLOVWXG\FORVXUHRUWKHGHDWKRIWKHVXEMHFWVLUUHVSHFWLYHRIZLWKGUDZDOVIURPWKHWUHDWPHQWV
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EHIROORZHGE\WKHLQYHVWLJDWRUXQWLOUHVROXWLRQRUXQWLODFOLQLFDOO\VWDEOHHQGSRLQWLVUHDFKHG
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9.4
Safety Variables 
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7R[LFLW\	DGYHUVHHYHQWVDVDVVHVVHGE\1&,&7&$(Y
x
6DIHW\ODERUDWRU\H[DPLQDWLRQ8ULQDO\VLVKHPDWRORJ\DQGVHUXPFKHPLVWU\
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9LWDOVLJQVEORRGSUHVVXUHUHVSLUDWRU\UDWHSXOVHDQGWHPSHUDWXUH
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/LYHUDQGUHQDOIXQFWLRQV
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3K\VLFDOH[DP
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10 RESPONSE CRITERIA
Criteria for Tumor Response by RECIST 1.1:
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WKH FKHVW DEGRPHQ DQG SHOYLV DUHD $ %DVHOLQH6FUHHQLQJ WXPRU EXUGHQ ZLOO EH REWDLQHG E\
HYDOXDWLQJWKHHQWLUHRUJDQV\VWHPVLQFOXGHGLQWKHERG\V\VWHPVLPDJHG7KLVWXPRUEXUGHQZLOO
EHFDWHJRUL]HGDVHLWKHU0HDVXUDEOH7DUJHW/HVLRQVRU1RQ0HDVXUDEOH1RQ7DUJHW/HVLRQV
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DVVHVVPHQWRIRQWUHDWPHQWUHVSRQVH


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2%,3KDUPD,QF
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10.1
Definitions for Measurability of Tumor Lesions
0HDVXUDEOH
7XPRUOHVLRQVPXVWEHDFFXUDWHO\PHDVXUHGLQDWOHDVWRQHGLPHQVLRQORQJHVWGLDPHWHULQWKH
SODQHRIPHDVXUHPHQWLVWREHUHFRUGHGZLWKDPLQLPXPVL]HRI
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PPE\&7VFDQ&7VFDQVOLFHWKLFNQHVVUHFRPPHQGHGWREHLQEHWZHHQPPDQG
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ZLWKFDOLSHUVVKRXOGEHUHFRUGHGDVQRQPHDVXUDEOH
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0DOLJQDQWO\PSKQRGHV
7REHFRQVLGHUHGSDWKRORJLFDOO\HQODUJHGDQGPHDVXUDEOHDO\PSKQRGHPXVWEHtPPLQVKRUW
D[LVZKHQDVVHVVHGE\&7VFDQ&7VFDQVOLFHWKLFNQHVVUHFRPPHQGHGWREHLQEHWZHHQPP
DQGPP$WEDVHOLQHDQGGXULQJIROORZXSRQO\WKHVKRUWD[LVZLOOEHPHDVXUHGDQGIROORZHG
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RQO\PSKQRGHPHDVXUHPHQW7XPRUOHVLRQVVLWXDWHGLQDSUHYLRXVO\LUUDGLDWHGDUHDRULQDQDUHD
VXEMHFWHGWRRWKHUORFRUHJLRQDOWKHUDS\DUHXVXDOO\127FRQVLGHUHGPHDVXUDEOHXQOHVVWKHUHKDV
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10.2
Recording Tumor Lesions
:KHQPRUHWKDQPHDVXUDEOHOHVLRQLVSUHVHQWDWEDVHOLQHDOOOHVLRQVXSWRDPD[LPXPRI5 lesions 
totalDQGDPD[LPXPRI2 lesionsSHURUJDQUHSUHVHQWDWLYHRIDOOLQYROYHGRUJDQVVKRXOGEH
LGHQWLILHGDV target lesions DQGZLOOEHUHFRUGHGDQGPHDVXUHGDWEDVHOLQHWKLVPHDQVLQLQVWDQFHV
ZKHUHVXEMHFWVKDYHRQO\RURUJDQVLWHVLQYROYHGDPD[LPXPRIDQGOHVLRQVUHVSHFWLYHO\
ZLOOEHUHFRUGHG
$VXPRIWKHGLDPHWHUVORQJHVWIRUQRQQRGDOOHVLRQVVKRUWD[LVIRUQRGDOOHVLRQVIRUDOOWDUJHW
OHVLRQVZLOOEHFDOFXODWHGDQGUHSRUWHGDVWKHEDVHOLQHVXPGLDPHWHUV,IO\PSKQRGHVDUHWREH
LQFOXGHGLQWKHVXPWKHQDVQRWHGDERYHRQO\WKHVKRUWD[LVLVDGGHGLQWRWKHVXP7KHEDVHOLQH
VXPGLDPHWHUVZLOOEHXVHGDVUHIHUHQFHWRIXUWKHUFKDUDFWHUL]HDQ\REMHFWLYHWXPRUUHJUHVVLRQLQ
WKHPHDVXUDEOHGLPHQVLRQRIWKHGLVHDVH
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non-target lesionsDQGVKRXOGDOVREHUHFRUGHGDWEDVHOLQH0HDVXUHPHQWVDUHQRWUHTXLUHGDQG
WKHVHOHVLRQVVKRXOGEHIROORZHGDVµSUHVHQW¶µDEVHQW¶RULQUDUHFDVHVµXQHTXLYRFDOSURJUHVVLRQ¶


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3DJHRI
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10.3
Response Evaluation
7DUJHW/HVLRQV
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3DUWLDO5HVSRQVH35$WOHDVWDGHFUHDVHLQWKHVXPRIGLDPHWHUVRIWDUJHWOHVLRQVWDNLQJ
DVUHIHUHQFHWKHEDVHOLQHVXPGLDPHWHUV
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TXDOLI\IRU3'WDNLQJDVUHIHUHQFHWKHVPDOOHVWVXPGLDPHWHUVZKLOHRQVWXG\0HDVXUHPHQWV
PXVWKDYHPHWWKH6'FULWHULDDWOHDVWRQFHDIWHUVWXG\HQWU\DWDPLQLPXPLQWHUYDORIZHHNV
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Table 3
Overall Response Table
Target Lesions
Non-Target Lesions
New Lesions1
Time Point Response
&5
&5
1R
&5
&5
6'
1R
35
&5
8(
1R
35
35
8(
1R
35
35
&5
1R
35
35
6'
1R
35
6'
8(
1R
6'
6'
&5
1R
6'
6'
6'
1R
6'
3'
$1<
<HV1R
3'
$1<
8QHTXLYRFDO3'3'
<HV1R
3'
$1<
$1<
<HV
3'
8(
1RQ3'
1R
8(
&5
1$
1R
&5
35
1$
1R
35
6'
1$
1R
6'
1$
6'
1R
6'
1$
&5
1R
&5
1$
8(
1R
8(
1$
1$
1R
8(
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UHVROYHG
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11 CRITERIA FOR REMOVAL FROM PROTOCOL THERAPY AND 
OFF STUDY CRITERIA
11.1
Criteria for Removal from Protocol Therapy
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WKHIROORZLQJUHDVRQV
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1RQFRPSOLDQFH
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6XEMHFWYROXQWDULO\ZLWKGUHZKLVKHUFRQVHQW
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6XEMHFWGHYHORSVD'/7


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2%,3KDUPD,QF
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3DJHRI
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([WUDRUGLQDU\PHGLFDOFLUFXPVWDQFHV6XEMHFWZKRLQWKHRSLQLRQRIWKH,QYHVWLJDWRUVKRXOG
EHGLVFRQWLQXHGIRUWKHLUZHOOEHLQJRULIDWDQ\WLPHWKHWUHDWPHQWVSUHVFULEHGE\WKLVSURWRFRO
DUHGHWULPHQWDO WR WKHVXEMHFW¶VKHDOWKWKHVXEMHFW PD\EHZLWKGUDZQIURP WKHVWXG\ VHH
6HFWLRQ,QWKLVHYHQWUHDVRQVIRUZLWKGUDZDOVKRXOGEHFOHDUO\GRFXPHQWHG
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6XEMHFWVZKRDUHRIISURWRFROWKHUDS\LQVWHDGRIGLVHDVHSURJUHVVLRQZLOOQHHGWRFRPSOHWH(QG
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$OOVXUYLYLQJVXEMHFWVZLOOEHIROORZHGXSIRUVXUYLYDOVWDWXVE\SKRQHFRQWDFWRUVXEMHFWV¶
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11.2
Off Study Criteria
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:LWKGUDZDORIFRQVHQW6XEMHFWGHFLGHVWRYROXQWDULO\ZLWKGUDZIURPWKHVWXG\ANDUHIXVHV
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12 STATISTICAL CONSIDERATIONS 
12.1
Hypotheses
1RIRUPDOVWDWLVWLFDOK\SRWKHVHVZLOOEHWHVWHG
12.2
Target Sample Size
$PD[LPXPQXPEHURIVXEMHFWVFDQEHHQUROOHGLQWKHGRVHHVFDODWLRQSKDVHDQGDPD[LPXP
QXPEHURIVXEMHFWVFDQEHHQUROOHGLQWKHFRKRUWH[SDQVLRQSKDVH$PD[LPXPRIWRWDO
VXEMHFWVFDQEHHQUROOHGLQWKLV3KDVH,VWXG\7KHVDPSOHVL]HVIRUWKHVWXG\DUHQRWGULYHQE\
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WKHSRWHQWLDOGRVHUHVSRQVHUHODWLRQVKLSWRIDFLOLWDWHGRVHVHOHFWLRQIRUVXEVHTXHQWVWXGLHV
12.3
Safety and Toxicity
7R[LFLW\ JUDGHG E\ WKH 86 1&, &RPPRQ 7R[LFLW\ &ULWHULD 9HUVLRQ  LQ FRQMXQFWLRQ ZLWK
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12.4
Statistical Methods
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12.5
Safety Analysis
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Immune Response Analysis
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12.7
Exploratory Analysis of Other Biomarkers
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13.1
Adverse Events
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Anticipated Adverse Events
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Data and Safety Monitoring Board 
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14 STUDY ADMINISTRATION AND MONITORING 
14.1
Institutional Review Board Approval
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Informed Consent Forms
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Study Conduct and Monitoring
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14.4
Case Report Forms
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Source Documents
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Retention of Documents
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Quality Control and Quality Assurance
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Drug Accountability
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16 APPENDICES
APPENDIX I: OBI-833 AND OBI-821 MIXING INSTRUCTION FOR 
SUBCUTANEOUS ADMINISTRATION
 Storage Condition:  Both 2%,DQG2%,YLDOVDUHWREHVWRUHGDWR&
 Study Cohorts
x
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x
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 Investigational Drugs:
Orange Vial (OBI-821)
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WRREWDLQ2%,VROXWLRQ Fully dissolveWKHFRQWHQWVRIWKHYLDO2UDQJH9LDOE\
JHQWO\LQYHUWLQJWKHYLDOWLPHVDo not shake the vial vigorously.$FFRUGLQJWRGUXJ
PL[LQJ SURFHGXUHV IRU WKUHH FRKRUWV 2%, LV PL[HG ZLWK 2%, LPPHGLDWHO\ IRU
LQMHFWLRQDIWHUUHFRQVWLWXWHGZLWK:),
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Dosing Cohort
Water for Injection
(mL) added to 
Orange vial
Cohort 12%,HTXLYDOHQWWRȝJ*ORER+ȝJ2%,

Cohort 22%,HTXLYDOHQWWRȝJ*ORER+ȝJ2%,

Cohort 32%,HTXLYDOHQWWRȝJ*ORER+ȝJ2%,

Green Vial (OBI-833)
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Dosing Cohort
Water for Injection
(mL) added to Green 
Vial
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Cohort 32%,HTXLYDOHQWWRȝJ*ORER+ȝJ2%,
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Dosing Cohort
Volume of Green 
Vial (mL) to be 
added to Orange 
Vial (OBI-821)
Total Volume 
Administered (mL) 
from Orange Vial  
(OBI-821)
Cohort 12%,HTXLYDOHQWWRȝJ
*ORER+ȝJ2%,
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Cohort 22%,HTXLYDOHQWWRȝJ
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
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Cohort 32%,HTXLYDOHQWWRȝJ
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,WLVKLJKO\UHFRPPHQGHGWKDWthe administration of the combined product should occur 
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APPENDIX II:
PROHIBITED CONCOMITANT MEDICATION
[Dose Escalation Phase]
Chemotherapeutic Agents:
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Immunotherapy 
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Alternative and complementary medicine may affect immune system 
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Subjects who continuous treatment after disease progression are allowed to 
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APPENDIX III: ECOG PERFORMANCE STATUS AND RECIST 1.1 
GUIDELINE
 ECOG Performance

These scales and criteria are used by doctors and researchers to assess how a subject's disease is 
progressing, assess how the disease affects the daily living abilities of the subject, and determine 
appropriate treatment and prognosis. They are included here for health care professionals to access.

ECOG PERFORMANCE STATUS*
Grade
ECOG

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Oken, M.M., Creech, R.H., Tormey, D.C., Horton, J., Davis, T.E., McFadden, E.T., Carbone, P.P.: Toxicity And 
Response Criteria Of The Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649-655, 1982.
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E.A. Eisenhauer, P. Therasse, J. Bogaerts et al., “New Response Evaluation Criteria in Solid Tumours: 
Revised RECIST Guideline (Version 1.1),” European Journal of Cancer, 45 (3) 228-247 (2009).
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