BLU-924 for advanced pancreatic, lung or colorectal cancer with KRAS mutations
Tests BLU-924, a KRAS inhibitor, in adults with advanced KRAS-mutated cancers.
Plain-language title generated from the registry record
Registry title: A First-in-Human Trial of BLU-924 (SAR449336) in Advanced Solid Tumors Harboring KRAS Mutations
Key facts
- Where
- Barcelona, Madrid, Pamplona, and Pozuelo de Alarcón, SpainSee the 6 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with metastatic pancreatic, lung or colon/rectal cancer that has a specific KRAS mutation and who have already had the standard treatments.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Metastatic pancreatic ductal adenocarcinoma, non-small cell lung cancer or colorectal cancer, with disease that can be measured by RECIST v1.1 and ECOG performance status 0-1.
- Earlier treatment
- Must have had all standard treatments for their cancer type in the metastatic setting, unless they cannot receive them for medical reasons. Must not have had earlier treatment aimed at KRAS.
- Biomarker or test result
- A single KRAS mutation (G12C, G12D, G12V, G12A, G12S or G13D) found in tumor tissue or circulating tumor DNA (ctDNA).
Main reasons for not taking part
- Another cancer within the last 2 years (some exceptions in the protocol)
- Active brain metastases
- Earlier treatment aimed at KRAS, including pan-KRAS, multi-RAS and mutant-selective KRAS inhibitors, and RAS or KRAS degraders
- Active or uncontrolled infection such as tuberculosis, hepatitis B, hepatitis C or HIV
Read by machine on 9 November 2026.
Where in Spain
- Hospital Universitario Vall d'HebronBarcelona, SpainContact: Blueprint MedicinesNot yet recruiting
- Mi Cancer Center Barcelona (Pratia Sirius Barcelona)Barcelona, SpainContact: Blueprint MedicinesNot yet recruiting
- Hospital General Universitrio Gregorio MaranonMadrid, SpainContact: Blueprint MedicinesNot yet recruiting
- Hospital Universitario 12 de OctubreMadrid, SpainContact: Blueprint MedicinesNot yet recruiting
- Clinica Universidad de Navarra (CUN)Pamplona, SpainContact: Blueprint MedicinesNot yet recruiting
- NEXT Oncology - MadridPozuelo de Alarcón, SpainContact: Blueprint MedicinesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Blueprint Medicines Corporation
- Trial code
- NCT07629960
- Record updated
- 21 September 2026
- Original description
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.Read full original descriptionShow less
A Phase 1/2, Open-Label, Dose-Escalation, Dose-Enrichment, and Dose-Expansion Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BLU-924 (SAR449336) as Monotherapy and Combination Therapy in Participants With Advanced Pancreatic Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer Harboring KRAS Mutations
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.
Inclusion: 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.
Exclusion: Have received prior targeted treatment(s) against KRAS, including pan-KRAS inhibitors, multi-RAS inhibitors, mutant-selective KRAS inhibitors, and RAS or KRAS degraders; History of additional malignancy within the last 2 years, with some exceptions as specified in the protocol; 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; Active brain metastases (participants with asymptomatic brain metastases may be eligible).