Clinical trial · Interventional
A First-in-Human Trial of BLU-924 (SAR449336) in Advanced Solid Tumors Harboring KRAS Mutations
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
NCT07629960CI-TRIAL-00123516recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BLU-924 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Monotherapy Part: BLU-924 Dose Escalation, Dose Enrichment, and Dose Expansion
- description
- 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.
- interventionNames
- Drug: BLU-924
Primary outcomes (5)
- measure
- Dose Escalation and Enrichment: Percentage of Participants with Dose-limiting Toxicity (DLTs)
- timeFrame
- Up to 5 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.