drugset / Trial / NCT04882917
First-in-human Study of M4076 in Advanced Solid Tumors (DDRiver Solid Tumors 410)
Phase 1
Completed
22 enrolled
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
The purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) (if reached) and early signs of efficacy of M4076 monotherapy in participants with solid tumors in dose escalation (Part 1A). Once the recommended dose for expansion (RDE) was declared in Part 1A, a preliminary food effect cohort, Part 1B, will follow at the RDE determined from Part 1A.
Timeline
- Start
- 2021-05-24
- Primary completion
- 2023-03-31
- Completion
- 2023-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lartesertib | Small molecule | 100 mg | Oral |
| Subject | Lartesertib | Small molecule | 200 mg | Oral |
| Subject | Lartesertib | Small molecule | 300 mg | Oral |
| Subject | Lartesertib | Small molecule | 400 mg | Oral |