What is the Purpose of this Study?
Primary - for the dose escalation parts (1A/1B/1C/1D/1E) To evaluate the safety and tolerability of S241656 in the different indications and cumulatively when administered as monotherapy and in combinations Secondary - for the dose escalation parts (1A/1B/1C/1D/1E) To characterize the plasma PK profile of S241656 and its metabolite S243796 (formerly BDTX-7037) To evaluate the antitumor activity of S241656 when administered as monotherapy and in combination. Estimate the BED range of S241656 in the different indications when administered as monotherapy and in combinations. Exploratory - for the dose escalation parts (1A/1B/1C/1D/1E) To evaluate tumor and blood-based markers of response and resistance to S241656 using ctDNA at baseline and serially on therapy To identify potential circulating metabolites of S241656 Primary - for dose optimization and expansions in monotherapy and in combination; food-effect sub-study To evaluate the antitumor activity of S241656 when administered as monotherapy and in combination Secondary- for dose optimization and expansions in monotherapy and in combination; food-effect sub-study Evaluate and confirm the BED of S241656 in the different indications when administered as monotherapy and in combination To further evaluate the antitumor activity of S241656 To characterize the plasma PK profile of S241656 and its metabolite S243796 Exploratory - for dose optimization and expansions in monotherapy and in combination; food-effect sub-study To evaluate tumor and blood-based markers of response and resistance to S241656 using ctDNA at baseline and serially on therapy To characterize the urine (only in dose optimization) PK profile of S241565 and its metabolite S243796 To identify potential circulating metabolites of S241656 To assess the effect of food on the plasma PK of S241656 and S243796 (only in Part 2F)
Eligibility
- * 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.
Where can I participate?
CS Cancer at The Angeles Clinic and Research Institute : Saba Mukarram
More about this Clinical Trial
What is the full name of this clinical trial?
BDTX-4933-101: A Phase 1/2, Open-label Study of Oral S241656 as Monotherapy and in Combination with Other Anti-Cancer Therapies in Patients with KRAS, BRAF and Other Selected RAS/MAPK Mutation-Positive Malignancies