BLU-924 for Advanced Solid Tumors with KRAS Mutations
This study is testing a new drug called BLU-924 (also known as SAR449336) in people with advanced solid tumors that have a specific genetic change called a KRAS mutation. This includes pancreatic cancer, non-small cell lung cancer, and colorectal cancer. Researchers want to see how safe BLU-924 is, what side effects it might cause, and if it can shrink tumors. To join, you must have a confirmed diagnosis of one of these cancers with a KRAS mutation, which will be checked in your tumor tissue or blood. The study will look at how the drug is handled by your body and its effects over time. The status of this study is currently unclear, and it plans to enroll 265 participants.
- Study design
- This is an open-label, multi-center study, meaning both you and your doctors will know you are receiving BLU-924. It is a Phase 1/2 study that will evaluate the drug in approximately 265 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety and side effects for up to 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A First-in-Human Trial of BLU-924 (SAR449336) in Advanced Solid Tumors Harboring KRAS Mutations
At a glance
Conditions
Where it's being run
3 sites across 2 statesWho to contact
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What this trial measures
- Dose Escalation and Enrichment: Percentage of Participants with Dose-limiting Toxicity (DLTs)Up to 5 years
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.
- Dose Escalation, Enrichment and Expansion: Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) and Serious AEsUp to 5 years
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.
- Dose Escalation and Enrichment: Maximum Tolerated Dose (MTD) of BLU-924Up to 5 years
- Dose Escalation and Enrichment: Recommended Dose for Expansion (RDFE) of BLU-924Up to 5 years
- Dose Expansion: Overall Response Rate (ORR)Up to 5 years