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

Amgen

Status and phase: Completed; Phase 1

Conditions: Acute Lymphoblastic Leukemia

Treatments: Drug: Blinatumomab; Drug: Dexamethasone Premedication; Drug: AMG 404

Study type: Interventional

Funder types: Industry

Identifiers

NCT04524455

20190177

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Blinatumomab and AMG 404

Experimental group

Treatment:

Drug: AMG 404

Drug: Dexamethasone Premedication

Drug: Blinatumomab