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Also known as SAR449336
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 | 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 |
BLU-924 is an investigational small molecule being studied for the treatment of advanced solid tumors that harbor KRAS mutations. The Phase 1 trial enrolls adults with advanced solid tumors, including non-small cell lung cancer, colorectal neoplasms, and pancreatic ductal adenocarcinoma. It is not approved for any use and remains in clinical development.
BLU-924 is being developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi is running the first-in-human study of the compound, also identified as SAR449336, in patients with KRAS-mutant advanced solid tumors.
BLU-924 is in Phase 1 development. The single trial of the program is a first-in-human, open-label, uncontrolled study that is currently recruiting participants. No Phase 2 or Phase 3 studies of BLU-924 have been initiated, and the drug has not been approved by the FDA.
BLU-924 is being evaluated in the trial NCT07629960, titled A First-in-Human Trial of BLU-924 (SAR449336) in Advanced Solid Tumors Harboring KRAS Mutations. The study is recruiting up to 265 adults aged 18 and older across sites in the United States and Spain, and it is not randomized or blinded.
Yes, BLU-924 is also known as SAR449336. The two names refer to the same investigational small molecule, and the first-in-human oncology trial lists both identifiers in its title. Sanofi is the developer behind both designations.
Yes, BLU-924 is being studied in a biomarker-selected population. The Phase 1 trial enrolls only patients whose advanced solid tumors harbor KRAS mutations, spanning non-small cell lung cancer, colorectal neoplasms, and pancreatic ductal adenocarcinoma. This enrichment strategy focuses the study on tumors with a defined molecular alteration.