drugset / Trial / NCT03258398
A Study to Evaluate eFT508 Alone and in Combination With Avelumab in Subjects With MSS Colorectal Cancer
Phase 2
Completed
56 enrolled
Effector Therapeutics
Merck KGaA, Darmstadt, Germany · collabPfizer · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 2, open-label, 2-part, multicenter study in subjects with MSS relapsed/refractory colorectal cancer. The primary objective of Part 1 is to evaluate the safety and tolerability of escalating doses of eFT508 in combination with a fixed dose of avelumab to determine the maximum tolerated dose (MTD) of eFT508 and to select a recommended dose for Part 2. The primary objective of Part 2 is to evaluate antitumor activity of eFT508 at the recommended dose in combination with avelumab or eFT508 monotherapy. Parts 1 and 2 will also evaluate pharmacokinetics (PK) and pharmacodynamics.
Timeline
- Start
- 2017-09-18
- Primary completion
- 2019-03-26
- Completion
- 2019-05-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avelumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Tomivosertib | Small molecule | — | Oral |