Phase 1/2 Study of S241656 for Cancers with Specific RAS/MAPK Mutations
Sponsor: Institut de Recherches Internationales Servier
ClinicalTrials ID:NCT05786924
This clinical trial is testing a new drug, S241656, to see if it is safe and well-tolerated in adults with certain advanced cancers that have specific genetic mutations. The study will explore how the drug works alone and in combination with other cancer treatments.
Patient Parameters
| Parameter | Options |
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Program Overview
The study is designed to evaluate the safety and tolerability of a new drug, S241656, in adults with advanced cancers that have specific genetic mutations in the RAS/MAPK pathway. The trial will be conducted in two parts: the first part will determine the best dose of the drug, and the second part will expand the study to include more patients. Participants will take the drug orally in 28-day cycles until their cancer progresses, they experience unacceptable side effects, they choose to stop, or the study ends.
Eligibility Criteria
Inclusion Criteria
- Expected to live at least 12 more weeks according to the study doctor.
- Have advanced or metastatic solid tumors with specific RAS or RAF genetic mutations.
- Have good bone marrow and organ function.
- Have recovered from side effects of previous cancer treatments.
For Part 1 (Dose Escalation):
- Advanced/metastatic non-small cell lung cancer (NSCLC) with specific mutations.
- Advanced/metastatic gastrointestinal (GI) tumors with specific mutations.
- Advanced/metastatic pancreatic cancer with specific mutations.
- Advanced/metastatic colorectal cancer with specific mutations.
- Other advanced/metastatic solid tumors with specific mutations.
For Part 2 (Dose Optimization and Expansion):
- Advanced/metastatic NSCLC with specific mutations.
- Advanced/metastatic pancreatic cancer with specific mutations.
- Advanced/metastatic colorectal cancer with specific mutations.
- Advanced/metastatic biliary tract cancer with specific mutations.
Exclusion Criteria
- Cancer with a known MEK1/2 mutation.
- Allergy to the study drug or any combination treatments used in the trial.
- Recent major surgery or planned surgery during the study.
- Currently receiving other cancer treatments or radiation therapy.
- Uncontrolled infections requiring treatment.
- Significant heart disease.
- Spinal cord compression causing symptoms.
- Other active cancers needing treatment within the next 2 years.
- History or risk of retinal vein occlusion.
- Pregnant or breastfeeding women.
- Participating in another clinical trial with treatment.
- Previous use of experimental drugs targeting the KRAS/BRAF/MEK/ERK pathway.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Banner Health- MD Anderson Cancer Center | 85234 | Gilbert | Arizona |
| University of Colorado - Aurora Cancer Center | 80045 | Aurora | Colorado |
| Georgetown University Lombardi Cancer Center | 20007 | Washington D.C. | District of Columbia |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
| South Texas Accelerated Research Therapeutics (START) Midwest | 49546 | Grand Rapids | Michigan |
| Masonic Cancer Center University of Minnesota | 55455 | Minneapolis | Minnesota |
| Washington University | 63130 | St Louis | Missouri |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| NEXT Virginia | 22031 | Fairfax | Virginia |
| Fred Hutchinson Cancer Research Center | 98109 | Seattle | Washington |
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