Phase 1
N=17
Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL
Acute Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT04524455 ↗Enrolled (actual)
17
Serious AEs
81.3%
Results posted
Apr 2024
Primary outcome: Primary: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Blinatumomab (Drug); AMG 404 (Drug); Dexamethasone Premedication (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) |
0; 0 | — |
| PRIMARY Number of Participants Who Experienced Treatment-Emergent AEs (TEAEs) |
8; 8; 6; 7; 8; 6 | — |
| SECONDARY Percentage of Participants Who Achieved Complete Remission (CR) or CR With Partial Hematological Recovery (CRh) (CR/CRh) |
37.5; 62.5; 37.5; 62.5 | — |
| SECONDARY Percentage of Participants Who Achieved CR |
25.0; 50.0; 25.0; 50.0 | — |
| SECONDARY Median Duration of CR in Participants Who Achieved CR Within First 2 Cycles |
NA; NA | — |
| SECONDARY Median Duration of CR/CRh in Participants Who Achieved CR/CRh Within First 2 Cycles |
NA; NA | — |
| SECONDARY Steady-state Concentrations (Css) of Blinatumomab |
152; 676; 779; 210; 638; 626 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of AMG 404 |
70.2; 175 | — |
| SECONDARY Time to Cmax (Tmax) of AMG 404 |
2.5; 1.5 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time 0 to 28 Days Post Infusion (AUC0-28d) of AMG 404 |
750; 1920 | — |
| SECONDARY Number of Participants With Incidences of Anti-Blinatumomab Antibodies |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Incidences of Anti-AMG 404 Antibodies |
0; 0 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT04524455). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.