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Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL

Status: complete

The primary objective of this phase 1b study is to evaluate the safety and tolerability of blinatumomab and AMG 404 in combination in adults with R/R B-ALL and to estimate the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AMG 404 when combined with continuous intravenous infusion (cIV) blinatumomab.

Inclusion Criteria

Age ≥ 18 years at enrollment.
Greater than or equal to 5% blasts in the bone marrow.
Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2.
Negative pregnancy test in women of childbearing potential.

Exclusion Criteria

Cancer chemotherapy (radiotherapy, chemotherapy, antibody therapy, molecular targeted therapy) within 14 days prior to study Day 1.
Known hypersensitivity to blinatumomab or AMG 404 or to any component of the product formulation.

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