NCT07629960

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for phase_1

Timeline
58mo left

Started Jun 2026

Longer than P75 for phase_1

Geographic Reach
2 countries

16 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jun 2026Jul 2031

First Submitted

Initial submission to the registry

June 1, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

June 4, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

September 21, 2026

Status Verified

September 1, 2026

Enrollment Period

3.2 years

First QC Date

June 1, 2026

Last Update Submit

September 16, 2026

Conditions

Advanced Solid TumorNon-Small Cell Lung CancerColorectal NeoplasmsPancreatic Ductal Adenocarcinoma

Keywords

Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) MutationMetastatic Non-Small Lung Cell CancerMetastatic Colorectal Cancer (CRC)Metastatic Pancreatic Ductal AdenocarcinomaKRAS G12AKRAS G12CKRAS G12DKRAS G12SKRAS G12VSolid Tumor, AdultKRAS-mutantKRAS-positiveKRAS G13DPan-KRAS inhibitorKRAS inhibitorFirst-in-humanSolid tumorAdvanced cancerAdult solid tumorMetastatic solid tumorColorectal cancerColon cancerRectal cancerMetastatic colorectal cancerPancreatic cancerPancreatic ductal adenocarcinomaPDACMetastatic pancreatic cancerLung cancerNSCLCPrecision oncologyTargeted therapy

Outcome Measures

Primary Outcomes (5)

  • Dose Escalation and Enrichment: Percentage of Participants with Dose-limiting Toxicity (DLTs)

    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.

    Up to 5 years

  • Dose Escalation, Enrichment and Expansion: Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) and Serious AEs

    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.

    Up to 5 years

  • Dose Escalation and Enrichment: Maximum Tolerated Dose (MTD) of BLU-924

    Up to 5 years

  • Dose Escalation and Enrichment: Recommended Dose for Expansion (RDFE) of BLU-924

    Up to 5 years

  • Dose Expansion: Overall Response Rate (ORR)

    Up to 5 years

Secondary Outcomes (13)

  • Dose Escalation and Enrichment: Overall Response Rate (ORR)

    Up to 5 years

  • Dose Escalation, Enrichment, and Expansion: Duration of Response (DOR)

    Up to 5 years

  • Dose Escalation, Enrichment, and Expansion: Disease Control Rate (DCR)

    Up to 5 years

  • Dose Escalation, Enrichment and Expansion: Progression-free Survival (PFS)

    Up to 5 years

  • Dose Expansion: Overall Survival (OS)

    Up to 5 years

  • +8 more secondary outcomes

Study Arms (1)

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.

Drug: BLU-924

Interventions

BLU-924DRUG

Tablet

Also known as: SAR449336
Monotherapy Part: BLU-924 Dose Escalation, Dose Enrichment, and Dose Expansion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
  • 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.

You may not qualify if:

  • History of additional malignancy within the last 2 years, with some exceptions as specified in the protocol.
  • Active brain metastases (participants with asymptomatic brain metastases may be eligible).
  • Have received prior targeted treatment(s) against KRAS, including pan-KRAS inhibitors, multi-RAS inhibitors, mutant-selective KRAS inhibitors, and RAS or KRAS degraders.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Florida Cancer Specialists & Research Institute - Sarasota

Sarasota, Florida, 34242, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

NOT YET RECRUITING

Massachusetts General Hospital - Main Campus

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

University of Michigan Medical School Rogel Cancer Center

Ann Arbor, Michigan, 48109-5843, United States

NOT YET RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601-2191, United States

NOT YET RECRUITING

NYU Langone Health Perlmutter Cancer Center

New York, New York, 10016, United States

NOT YET RECRUITING

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

NOT YET RECRUITING

The University of Texas MD Anderson Cancer Center - Texas Medical Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

Next Oncology Virginia Cancer Specialist

Fairfax, Virginia, 22031, United States

RECRUITING

Mi Cancer Center Barcelona (Pratia Sirius Barcelona)

Barcelona, Catalonia, 08017, Spain

NOT YET RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, Catalonia, 08035, Spain

NOT YET RECRUITING

Hospital General Universitrio Gregorio Maranon

Madrid, Madrid, 28007, Spain

NOT YET RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28009, Spain

NOT YET RECRUITING

NEXT Oncology - Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

NOT YET RECRUITING

Clinica Universidad de Navarra (CUN)

Pamplona, Navarre, 31008, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungColorectal NeoplasmsNeoplasm MetastasisColonic NeoplasmsRectal NeoplasmsPancreatic NeoplasmsLung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Central Study Contacts

Blueprint Medicines

CONTACT

1-888-258-7768medinfo@blueprintmedicines.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 5, 2026

Study Start

June 4, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

July 1, 2031

Last Updated

September 21, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org.

Locations

ES(6)US(10)