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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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 AEs — Up 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-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
Trial sites (16)
Facility
City
Region
Status
Florida Cancer Specialists & Research Institute - Sarasota
Sarasota
Florida
Recruiting
Moffitt Cancer Center
Tampa
Florida
Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge
Louisiana
Not Yet Recruiting
Massachusetts General Hospital - Main Campus
Boston
Massachusetts
Not Yet Recruiting
University of Michigan Medical School Rogel Cancer Center
Ann Arbor
Michigan
Not Yet Recruiting
Hackensack University Medical Center
Hackensack
New Jersey
Not Yet Recruiting
NYU Langone Health Perlmutter Cancer Center
New York
New York
Not Yet Recruiting
Tennessee Oncology, PLLC
Nashville
Tennessee
Not Yet Recruiting
The University of Texas MD Anderson Cancer Center - Texas Medical Center
Houston
Texas
Not Yet Recruiting
Next Oncology Virginia Cancer Specialist
Fairfax
Virginia
Recruiting
Mi Cancer Center Barcelona (Pratia Sirius Barcelona)
Barcelona
Catalonia
Not Yet Recruiting
Hospital Universitario Vall d'Hebron
Barcelona
Catalonia
Not Yet Recruiting
Hospital General Universitrio Gregorio Maranon
Madrid
Madrid
Not Yet Recruiting
Hospital Universitario 12 de Octubre
Madrid
Madrid
Not Yet Recruiting
NEXT Oncology - Madrid
Pozuelo de Alarcón
Madrid
Not Yet Recruiting
Clinica Universidad de Navarra (CUN)
Pamplona
Navarre
Not Yet Recruiting
More Blueprint Medicines Corporation trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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