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M1231 · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| Part 1: M1231 | EXPERIMENTAL | Participants with solid tumors for whom no effective standard therapy exists will be included in this Part. Dose escalation of M1231 will be administered as single agent. |
| Part 2: Cohort A M1231: Metastatic NSCLC | EXPERIMENTAL | Participants with metastatic Non-small Cell Lung Cancer (NSCLC) expressing Epidermal Growth Factor Receptor (EGFR) and Mucin 1 (MUC1) on archival tumor tissue will receive M1231 at the dose determined as recommended dose for expansion (RDE) in Part 1. |
| Part 2: Cohort B M1231: Metastatic Esophageal Squamous Cell Carcinoma | EXPERIMENTAL | Participants with metastatic esophageal squamous cell carcinoma will receive M1231 at the dose determined as recommended dose for expansion (RDE) in Part 1. |
| Name | Type | Description |
|---|---|---|
| M1231 | DRUG | M1231 will be administered at escalated doses every three weeks until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study. |
Inclusion Criteria: For Part 1 and 2: * The Investigator reviews the medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a female with an early undetected pregnancy For Part 1: * Locally advanced or metastatic disease that is intolerant or refract...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
M1231 is an investigational small molecule being developed for the treatment of metastatic solid tumors, including esophageal cancer and non-small cell lung cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
M1231 is a small molecule designed to target specific molecular pathways involved in tumor growth. The exact molecular target has not been disclosed, but the drug is being evaluated in biomarker-selected patients with metastatic solid tumors, suggesting it may act on a defined genetic alteration.
M1231 is being developed by Merck KGaA, a German multinational pharmaceutical company. The company's stock is traded under the ticker MKGAF on over-the-counter markets.
M1231 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not received FDA approval and is still undergoing clinical evaluation for safety and efficacy in patients with metastatic solid tumors.
M1231 has been studied in one completed Phase 1 clinical trial, identified as NCT04695847, titled "M1231 in Participants With Solid Tumors." The trial enrolled 23 participants with metastatic solid tumors, esophageal cancer, or non-small cell lung cancer, and was conducted in the United States and Canada.
M1231 is a unique investigational compound developed by Merck KGaA. No alternative names or aliases have been reported for this drug. It is distinct from other oncology agents and is being evaluated specifically for its potential in treating metastatic solid tumors.