drugset / Trial / NCT04553692
Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants with Relapsed, Refractory, or Newly Diagnosed Cancers
RandomizedSequentialOpen-labelTreatment
Summary
This study is a first-in-human, Phase 1a/1b, multicenter, open-label study to determine the safety, tolerability, and pharmacokinetics of aplitabart as a single agent and in combination in participants with relapsed and/or refractory solid or hematologic cancers, as well as newly diagnosed cancers, and an open-label, randomized study of aplitabart+FOLFIRI+bevacizumab.
Timeline
- Start
- 2020-09-23
- Primary completion
- 2025-01-20
- Completion
- 2025-01-20
Outcome
Outcome not reported
Stopped (Business): “Study terminated due strategic corporate pivot to focus on auto-immune indications”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aplitabart | Monoclonal antibody | — | Intravenous |
| Subject | Azacitidine | Other / unclassified | — | — |
| Subject | Birinapant | Small molecule | — | Intravenous |
| Subject | Docetaxel | Small molecule | — | — |
| Subject | Gemcitabine | Small molecule | — | — |
| Subject | Venetoclax | Small molecule | — | — |
| Background | Bevacizumab | Monoclonal antibody | — | Intravenous |
| Background | Irinotecan | Small molecule | — | Intravenous |
| Background | Leucovorin | Small molecule | — | Intravenous |
| Background | fluorouracil | Small molecule | — | Intravenous |