drugset / Trial / NCT06421935
M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)
Phase 1
Active not recruiting
60 enrolled
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile of M9466 with and without tuvusertib or an ARPi and early signs of clinical activity of M9466 with tuvusertib in participants with advanced solid tumors. Study details include: Study/Treatment Duration: Participants will be treated until disease progression, death, discontinuation, or End of Study. Visit Frequency: Every week in the first 2 cycles, followed by every 3 weeks in the subsequent cycles. An End of Treatment Visit and Safety Follow-up/Discontinuation Visit are scheduled after the treatment period.
Timeline
- Start
- 2024-08-07
- Primary completion
- 2027-02-22
- Completion
- 2027-02-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | — | Oral |
| Subject | HRS-1167 | Unknown | — | Oral |
| Subject | Tuvusertib | Small molecule | — | Oral |
| Background | Prednisolone | Other / unclassified | — | Oral |
| Background | Prednisone | Other / unclassified | — | Oral |