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BLU-924 · 1 trial · 4 indications
Any of the prespecified AEs that are attributable to the study treatment, occurring in the DLT observation period are considered DLTs, excluding toxicities clearly due to underlying disease or extraneous causes.
An adverse event (AE) is any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
| Arm | Type | Description |
|---|---|---|
| Monotherapy Part: BLU-924 Dose Escalation, Dose Enrichment, and Dose Expansion | EXPERIMENTAL | Participants will receive BLU-924 oral tablet, once daily as monotherapy during Dose Escalation followed by Dose Enrichment. During Dose Enrichment, participants with PDAC, NSCLC or CRC will receive BLU-924 at selected dose levels below the current escalation dose or, if Dose Escalation is complete, below the MTD. During Dose Expansion, participants will receive RDFE of BLU-924 oral tablet, once daily as monotherapy determined during escalation monotherapy part. Dose Expansion may be initiated to further assess the safety, antitumor activity, PK, and pharmacodynamics of BLU-924 at RDFE in indication-specific cohorts (PDAC, NSCLC, or CRC) harboring a KRAS mutation. |
| Name | Type | Description |
|---|---|---|
| BLU-924 | DRUG | Tablet |
Inclusion Criteria: 1. Pathologically confirmed diagnosis of metastatic Kirsten rat sarcoma viral oncogene homolog (KRAS)-mutant pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), or colorectal cancer (CRC) with evidence of a single KRAS G12C, G12D, G12V, G12A, G12S, or G1...
| 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 |
BLU-924 is an investigational small molecule being developed for the treatment of advanced solid tumors, including non-small cell lung cancer, colorectal neoplasms, and pancreatic ductal adenocarcinoma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
BLU-924 is designed to target tumors harboring KRAS mutations. The drug is being studied in patients with advanced solid tumors that carry these genetic alterations, as part of a first-in-human clinical trial.
BLU-924 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 1 clinical trials for advanced solid tumors.
BLU-924 is in Phase 1 clinical development. It is an investigational drug being studied in a first-in-human trial for advanced solid tumors with KRAS mutations, and it is not yet approved for any use.
BLU-924 is being evaluated in a Phase 1 clinical trial with the identifier NCT07629960. This first-in-human study is recruiting patients with advanced solid tumors, non-small cell lung cancer, colorectal neoplasms, and pancreatic ductal adenocarcinoma in the United States.