A Phase 1/2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination with Other Anti-Cancer Therapies in Patients with KRAS, BRAF and Other Selected RAS/MAPK Mutation-Positive Malignancies

2025-523474-16-00 · tracked via the Priya Life Science EU tracker

Sponsor

Institut De Recherches Internationales Servier IRIS

Sponsor type

Pharmaceutical company

Therapeutic area

Neoplasms

Decision date

21/04/2026

Enrollment target

105

Sites

France, Spain, Denmark, Italy

Condition studied

Malignancies with Documented KRAS, BRAF and Other Selected RAS/MAPK Mutations

Investigational medicinal product(s)

FOLINATE DE CALCIUM HIKMA 10 mg/mLsolution injectable/pour perfusionOxaliplatin Kabi 5 mg/ml Konzentrat zur Herstellung einer InfusionslösungFluorouracil Hikma 50 mg/ml InjektionslösungS241656 film-coated tablet 200mgErbitux 5 mg/mL solution for infusionGemcitabin Hikma 38 mg/ml Konzentrat zur Herstellung einer InfusionslösungS241656 film-coated tablet 50mgBugvi 5 mg/ml pulbere pentru dispersie perfuzabilăIrinotecan Kabi 20 mg/ml Konzentrat zur Herstellung einer InfusionslösungS241656 film-coated tablet 25mgVectibix 20 mg/ml concentrate for solution for infusion

Eligibility

Age group

65+ years, 18-64 years

Sex

Female, Male

Primary endpoint

Dose Escalation: Incidence of dose-limiting toxicities occurring within the first 28-day cycle Number of Adverse Events and Serious Adverse Events Dose Expansion: Objective response

Endpoint detail

1. Dose Escalation: PK parameters of S241656 and its metabolite S243796, including but not limited to Cmax, tmax, AUC, and t½, 2. Dose Escalation: Objective response Disease Control Clinical Benefit Duration of Response Time to response Progression free survival Overall survival, 3. Dose Escalation: Clinical efficacy parameters Safety and tolerability parameters PK including: Exposure-toxicity relationship, 4. Dose Expansion: Clinical Efficacy Parameters Safety and Tolerability Parameters PK & PD parameters, 5. Dose Expansion: Disease Control Clinical Benefit Duration of Response Time to Response Progression free survival Overall Survival, 6. Dose Expansion: PK parameters of S241656 and its metabolite S243796, but not limited to Cmax, tmax, AUC, and t½

Official registry record

This page summarises publicly available CTIS 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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