A First-in-Human Trial of BLU-924 (SAR449336) in Advanced Solid Tumors Harboring KRAS Mutations

Part of paid clinical trials in Sarasota, Florida.

Sponsor
Blueprint Medicines Corporation
Study ID
NCT07629960
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BLU-924 — DRUG
    Tablet

Study Details

A first in human study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of BLU-924 / SAR449336, a pan-KRAS inhibitor, in participants with advanced Pancreatic Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer harboring KRAS mutations.

Key Dates

First listed
Jun 5, 2026
Start date
Jun 4, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2029
Completion
Jul 31, 2031

Study Design

Enrollment
265 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy Part: BLU-924 Dose Escalation, Dose Enrichment, and Dose Expansion
    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.

Primary Outcome Measure

Dose Escalation and Enrichment: Percentage of Participants with Dose-limiting Toxicity (DLTs) [ Time Frame: Up to 5 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Florida Cancer Specialists & Research Institute - SarasotaSarasotaFlorida34242-
Moffitt Cancer CenterTampaFlorida33612-
Next Oncology Virginia Cancer SpecialistFairfaxVirginia22031-

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Florida Cancer Specialists & Research Institute - Sarasota· Sarasota, FLMoffitt Cancer Center· Tampa, FLNext Oncology Virginia Cancer Specialist· Fairfax, VA

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