Evaluating BDTX-4933 for patients with specific cancer mutations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 clinical trial investigates the safety, tolerability, and preliminary effectiveness of BDTX-4933 in adults with advanced or metastatic cancers that have specific mutations in the KRAS, BRAF, or NRAS genes. The study consists of a dose escalation phase to determine the maximum tolerated dose and an expansion cohort focusing on non-small cell lung cancer with KRAS non-G12C mutations. Patients will take BDTX-4933 orally in 28-day cycles until their disease progresses or they choose to withdraw. The trial aims to provide insights into the drug's antitumor activity in these mutation-positive cancers.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Life expectancy of ≥ 12 weeks in the opinion of the investigator.
* Histologically or cytologically confirmed recurrent locally advanced (unresectable) or metastatic solid tumors with documented RAS or RAF mutations or alterations.
* Adequate bone marrow and organ function.
* Recovered from toxicity to prior anti-cancer therapy.

Part 1 Dose Escalation cohort ONLY:

* Part 1A: Advanced/metastatic NSCLC with KRAS non-G12C, HRAS, NRAS, BRAF or CRAF (RAF1) mutations or alterations
* Part 1B: Advanced/metastatic GI tumors (e.g., PDAC, CRC, and BTC) with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations
* Part 1C: Advanced/metastatic PDAC with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations
* Part 1D: Colorectal adenocarcinoma with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations
* Part 1E: Other advanced/metastatic non-GI, non-NSCLC solid tumors with KRAS, HRAS, NRAS, BRAF, CRAF (RAF1) mutations or alterations

Part 2 Dose Optimization and Expansion cohorts ONLY:

* Part 2A: Advanced/metastatic NSCLC with KRAS non-G12C mutations and/or BRAF mutations
* Part 2A1: Advanced/metastatic NSCLC with KRAS non-G12C mutations
* Part 2A2: Advanced/metastatic NSCLC with BRAF mutations
* Part 2A3: Advanced/metastatic NSCLC with KRAS non-G12C or BRAF mutations or alterations and active CNS metastatic disease
* Part 2A4: Advanced/metastatic NSCLC with a KRAS G12C mutation
* Part 2B1: Advanced/metastatic PDAC with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations
* Part 2B2: Advanced/metastatic CRC with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations
* Part 2B3: Advanced/metastatic BTC (adenocarcinoma) with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations

Key Exclusion Criteria:

* Cancer that has a known MEK1/2 mutation.
* Known allergy/hypersensitivity to excipients of S241656 or to any of the registered IMPs administered in combination.
* Any contra-indication, to use of any of the combination chemotherapy or anti-EGFR therapy partners administered as part of this trial.
* Major surgery within 4 weeks of study entry or planned during study.
* Ongoing anticancer therapy.
* Ongoing radiation therapy.
* Uncontrolled or active clinically relevant bacterial, fungal, or specific viral infection requiring systemic therapy.
* Clinically significant cardiovascular disease.
* Symptomatic spinal cord compression.
* Evidence of active malignancy (other than study-specific malignancies) requiring systemic therapy within the next 2 years.
* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
* Females who are pregnant or breastfeeding.
* Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.
* Prior use of experimental agents that target the KRAS/BRAF/MEK/ERK pathway.

Where it's running

• Banner Health- MD Anderson Cancer Center
  Gilbert, Arizona, United States Recruiting
• The Angeles clinic - A cedars SINAI AFFILIATE
  Los Angeles, California, United States Recruiting
• USC Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• University of California, San Francisco (UCSF)
  San Francisco, California, United States Recruiting
• Yale University School of Medicine - Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
• Email: scientificinformation@servier.com
• Phone: +33 1 55 72 60 00

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.