A Phase 1b Open-label Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Administration of Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (ALL)
Phase: PHASE1
Conditions: Acute Lymphoblastic Leukemia
Sponsor: Amgen

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Cohort 1
Blinatumomab (28d CIV)
AMG 404 (240 mg) 
Day 11 and Day 39 of C1, C3, C5; 
Day 25 for C2 and C4
De-escalate
Escalate
Cohort 2a
Blinatumomab start  D3 of C1 (28d CIV)
AMG 404 (480 mg) 

Cycle 1: C1D1, C1D29

Cycle 2: D13 & 41; 

Cycle 3: D27; 

Cycle 4: D13 & 41; 

Cycle 5: D27
Cohort 2b
Blinatumomab start  D3 of C1 (28d CIV)
AMG 404 (240 mg) 

Cycle 1: C1D1, C1D29

Cycle 2: D13 & 41; 

Cycle 3: D27; 

Cycle 4: D13 & 41; 

Cycle 5: D27
Dose expansion*
Blinatumomab (28d CIV)
AMG 404 (RP2D)
RP2D of AMG 404 will be determined in 
the dose exploration part
Cohort 1c
Blinatumomab start  D3 of C1 (28d CIV)
AMG 404 (120 mg) 

Cycle 1: C1D1, C1D29

Cycle 2: D13 & 41; 

Cycle 3: D27; 
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Cycle 4: D13 & 41; 

Cycle 5: D27
De-escalate if 
DLT in Cohort 2a  
using mTPI-2
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