Clinical trial · Interventional
Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 404 | Drug | — | UNRESOLVED |
| Blinatumomab | Drug | Blinatumomab | ALIAS |
| Dexamethasone Premedication | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Blinatumomab and AMG 404
- interventionNames
- Drug: Blinatumomab
- Drug: AMG 404
- Drug: Dexamethasone Premedication
Primary outcomes (2)
- measure
- Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
- timeFrame
- Cohort 1: Up to 67 days; Cohort 2a: Up to 56 days
- description
- Investigators determined whether an adverse event (AE) qualified as a DLT per pre-specified protocol defined criteria. An AE was defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment.
- measure
- Number of Participants Who Experienced Treatment-Emergent AEs (TEAEs)
- timeFrame
- Median (min, max) overall duration from first dose until 30 days after last dose is: 83.4 (40.2, 274.1) days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available