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

ID#: NCT04524455

Age: 18 - 99 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: October 02, 2020

End Date: February 21, 2023

Contact Information:
Amgen Call Center
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.
Eligibility: 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.