RecruitingPhase 1Phase 2NCT05786924

Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies

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

Sponsor

Institut de Recherches Internationales Servier

Enrollment

554 participants

Start Date

Apr 18, 2023

Study Type

INTERVENTIONAL

Summary

BDTX-4933-101 is a first-in-human, open-label, Phase 1/2 dose escalation, dose optimization and expansion study designed to evaluate the safety and tolerability of S241656 as monotherapy and in combination with other anti-cancer therapies in participants with selected advanced malignancies. The study population for the Dose Escalation part of the study comprises adults with recurrent advanced/metastatic non-small cell lung cancer (NSCLC), Gastrointestinal (GI) cancers, and other solid tumors harboring KRAS, HRAS, NRAS, BRAF, and/or CRAF (Rapidly Accelerated Fibrosarcoma (RAF1)) mutations or alterations. A dose optimization part in adults with NSCLC may follow the dose escalation phase if the sponsor, in consultation with the safety review committee, decides it is necessary to further characterize the optimal dose. However, the study may also proceed directly to the expansion phase. The study population for the Dose Expansion part of the study comprises adults with advanced/metastatic NSCLC with KRAS and/or BRAF mutations, and with Pancreatic Ductal AdenoCarcinoma (PDAC), ColoRectal Cancer (CRC), and Biliary Tract Cancer (BTC) with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations and alterations. All patients will self-administer S241656 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called S241656 in people with advanced cancers that have specific genetic mutations in the RAS or MAPK pathway — a signaling system that, when mutated, can cause cells to grow out of control. These mutations occur in many cancer types including lung, pancreatic, and colorectal cancers. **You may be eligible if...** - You are 18 or older with advanced or metastatic solid tumor cancer - Your tumor has been confirmed to have a RAS or RAF genetic mutation - Your cancer has returned or progressed despite prior treatment - Your organs are functioning well enough to tolerate treatment - Your life expectancy is at least 12 weeks **You may NOT be eligible if...** - Your cancer is a primary brain tumor - You have serious heart problems or active uncontrolled infections - You have had major surgery, radiation, or chemotherapy very recently - You are pregnant or breastfeeding - You cannot swallow oral medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGS241656

RAF inhibitor targeting all classes of oncogenic BRAF alterations (Classes I, II, and III) and constitutively active CRAF, KRAS or NRAS mutations

DRUGFOLFOX6/FOLFOX7