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

• Status: Recruiting
• Trial end date: 2023-02-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Blinatumomab; Dexamethasone

Criteria

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.