Recruiting
Phase 1
Phase 2

BLU-924 & SAR449336

Sponsor:

Blueprint Medicines Corporation

Code:

NCT07629960

Conditions

Advanced Solid Tumor

Non-Small Cell Lung Cancer

Colorectal Neoplasms

Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BLU-924

Study Details

Brief summary:

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.

Conditions

Advanced Solid Tumor

Non-Small Cell Lung Cancer

Colorectal Neoplasms

Pancreatic Ductal Adenocarcinoma

Study ID

NCT07629960

Start date

Jun 4, 2026

Status verified date

Aug, 2026

Completion date

Jul, 2031

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 G13D mutation in tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA).
2. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
4. Patients must have received all standard therapies for their cancer type in the metastatic setting, unless they are unable to receive such therapies due to clinical characteristics, comorbidities, or other medically justified reasons.

Exclusion Criteria:

1. History of additional malignancy within the last 2 years, with some exceptions as specified in the protocol.
2. Active brain metastases (participants with asymptomatic brain metastases may be eligible).
3. Have received prior targeted treatment(s) against KRAS, including pan-KRAS inhibitors, multi-RAS inhibitors, mutant-selective KRAS inhibitors, and RAS or KRAS degraders.
4. Active or uncontrolled systemic infection, such as tuberculosis, Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Enrollment

265 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

BLU-924

Tablet

Primary outcome measure

  • Dose Escalation and Enrichment: Percentage of Participants with Dose-limiting Toxicity (DLTs) [ Time Frame: Up to 5 years ]
  • Dose Escalation, Enrichment and Expansion: Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) and Serious AEs [ Time Frame: Up to 5 years ]
  • Dose Escalation and Enrichment: Maximum Tolerated Dose (MTD) of BLU-924 [ Time Frame: Up to 5 years ]
  • Dose Escalation and Enrichment: Recommended Dose for Expansion (RDFE) of BLU-924 [ Time Frame: Up to 5 years ]
  • Dose Expansion: Overall Response Rate (ORR) [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Locations

Florida Cancer Specialists & Research Institute - Sarasota

Recruiting

Sarasota, Florida, United States, 34242

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Next Oncology Virginia Cancer Specialist

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Blueprint Medicines Corporation

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation
  • Metastatic Non-Small Lung Cell Cancer
  • Metastatic Colorectal Cancer (CRC)
  • Metastatic Pancreatic Ductal Adenocarcinoma
  • KRAS G12A
  • KRAS G12C
  • KRAS G12D
  • KRAS G12S
  • KRAS G12V
  • Solid Tumor, Adult
  • KRAS-mutant
  • KRAS-positive
  • KRAS G13D
  • Pan-KRAS inhibitor
  • KRAS inhibitor
  • First-in-human
  • Solid tumor
  • Advanced cancer
  • Adult solid tumor
  • Metastatic solid tumor
  • Colorectal cancer
  • Colon cancer
  • Rectal cancer
  • Metastatic colorectal cancer
  • Pancreatic cancer
  • Pancreatic ductal adenocarcinoma
  • PDAC
  • Metastatic pancreatic cancer
  • Lung cancer
  • NSCLC
  • Precision oncology
  • Targeted therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Blueprint Medicines Corporation on 2026-08-24.