RecruitingPhase 2NCT06589440

Phase 2 Study of SR-8541A in Combination With Botensilimab and Balstilimab in Subjects With Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC)


Sponsor

Stingray Therapeutics

Enrollment

70 participants

Start Date

Nov 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, dose escalation and expansion, multi-center phase 2 study evaluating the safety and efficacy of SR-8541A administered orally in combination with intravenous botensilimab and balstilimab in subjects with MSS-CRC with and without active liver metastases.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase 2 study testing a new combination of three drugs — SR-8541A, botensilimab, and balstilimab — for people with metastatic colorectal cancer that has not responded to standard treatments. This type of colorectal cancer (called MSS or microsatellite stable) is typically resistant to immunotherapy, and this combination is designed to overcome that resistance. **You may be eligible if...** - You are 18 or older - You have confirmed advanced (unresectable or metastatic) colorectal cancer that is microsatellite stable (MSS) or proficient mismatch repair (pMMR) - You have received at least one prior chemotherapy regimen for metastatic disease - Your general health score (ECOG) is 0 or 1 - Your kidneys, liver, and blood counts are in adequate range **You may NOT be eligible if...** - You have previously received immunotherapy (PD-1, PD-L1, or CTLA-4 drugs) - You have recently had bowel obstruction or refractory ascites - You have active autoimmune disease requiring systemic treatment in the past 2 years - You have significant heart disease, active infections, or HIV/Hepatitis B or C - You are pregnant or breastfeeding 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

DRUGSR-8541A

SR-8541A administered orally in combination with intravenous botensilimab and balstilimab


Locations(6)

Atlantic Health

Morristown, New Jersey, United States

Texas Oncology- Austin

Austin, Texas, United States

Texas Oncology- Sammons- DFW

Dallas, Texas, United States

The University of Texas M.D. Anderson Cancer Center GI Medical Oncology Dept

Houston, Texas, United States

Texas Oncology- Northeast Texas

Tyler, Texas, United States

Swedish

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06589440