Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
M9466 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| M9466 plus Tuvusertib | EXPERIMENTAL | - |
| M9466 Monotherapy | EXPERIMENTAL | - |
| M9466 with AA-P(abiraterone acetate and prednisone or prednisolone) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| M9466 | DRUG | Participants will be administered M9466 orally. |
| Tuvusertib | DRUG | Participants will be administered Tuvusertib orally. |
| Abiraterone acetate | DRUG | Participants will be administered with Abiraterone acetate orally. |
| Prednisone/Prednisolone | DRUG | Participants will be administered with prednisone/prednisolone orally. |
Inclusion Criteria: * Module 1 Part A and Module 2 Part A1: Locally advanced or metastatic disease that is refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator * Module 1 Part A2: Histologically or pathologically confirmed advanced or metastatic ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
M9466 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is in Phase 1 clinical development and is not yet approved for any indication. The Phase 1 trial is evaluating M9466 both as a single agent and in combination with other therapies in adult patients with advanced solid tumors.
M9466 is being developed by Merck KGaA, which trades under the ticker MKGAF. The company is the sponsor of the Phase 1 clinical program evaluating M9466 in advanced solid tumors.
M9466 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The ongoing Phase 1 trial is designed to evaluate the drug in patients with advanced solid tumors.
M9466 is being evaluated in one active Phase 1 trial, NCT06421935, titled M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501). The trial has an enrollment of 60 participants and is currently active but not recruiting. It is being conducted in the United States, Australia, Japan, South Korea, and Spain.
No, M9466 is not FDA approved. It is an investigational small molecule in Phase 1 clinical development for advanced solid tumors. The only clinical trial of M9466 is an active Phase 1 study, and the drug remains under investigation for safety and preliminary activity.