Actively Recruiting
Phase 2 Study of SR-8541A in Combination With Botensilimab and Balstilimab in Subjects With Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC)
Led by Stingray Therapeutics · Updated on 2026-01-15
70
Participants Needed
6
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 2 Study of SR-8541A in Combination With Botensilimab and Balstilimab in Subjects With Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Be 18 years of age or older at consent
- Have a confirmed diagnosis of unresectable and metastatic colon or rectal adenocarcinoma
- Have non-microsatellite instability high or non-deficient mismatch repair tumor status by standard local testing
- Have received at least one prior chemotherapy regimen for metastatic or recurrent colorectal cancer
- Have an ECOG performance status of 0 or 1
- Have measurable disease according to RECIST v1.1
- Be able to provide archival or fresh tumor tissue during screening (required) and post-treatment (optional)
- Have adequate kidney function with creatinine clearance of at least 60 mL/min
- Have adequate liver function
- Have adequate blood cell counts
- Have not received growth factor support, blood transfusions, or albumin within 14 days before the first study dose
- Be willing and able to comply with scheduled visits, treatments, lab tests, and study procedures
- Male and female subjects of childbearing potential must agree to use a highly effective method of contraception and avoid sperm or egg donation during the study and for at least 3 months after the last dose
You will not qualify if you...
- Allergy or hypersensitivity to any study drugs or their ingredients
- Active liver metastases detected by CT or MRI in Part 2, Cohort A
- Treatment with tyrosine kinase inhibitors within 2 weeks before first dose
- Treatment with any other systemic therapy for colorectal cancer within 3 weeks before first dose
- Participation in another clinical trial or use of investigational drugs within 30 days before first dose
- Use of strong CYP enzyme inhibitors or inducers within 5 half-lives before first dose
- Prior treatment with PD-(L)1, CTLA-4, or other immune checkpoint inhibitors
- Partial or complete bowel obstruction in the last 3 months or signs of impending obstruction
- Refractory ascites
- Current or prior interstitial lung disease or pneumonitis requiring steroids
- Systemic corticosteroids over 10 mg prednisone equivalent or immunosuppressants within 28 days before Day 1
- Active autoimmune disease requiring systemic treatment in past 2 years
- Adrenal or pituitary insufficiency
- History of serious heart conditions or recent cardiovascular events within 6 months
- History of organ, stem cell, or bone marrow transplant
- Recent COVID-19 infection within 10 to 20 days before first dose depending on severity
- Need for treatment with strong CYP3A4 inducers or inhibitors
- Gastrointestinal conditions that affect drug absorption
- Elevated troponin I above normal limits
- Uncontrolled high blood pressure
- QTcF interval 470 ms or greater on ECG
- Left ventricular ejection fraction below 50%
- Symptomatic uncontrolled central nervous system disease needing steroids or anti-seizure meds within 2 months before Day 1
- Leptomeningeal disease or untreated spinal cord compression
- Bleeding disorders or anticoagulation that cannot be reversed quickly
- Other progressing cancers or recent treatment for other malignancies except certain cured cancers
- Uncontrolled seizures, substance abuse, or psychiatric conditions interfering with study
- Active infection requiring systemic treatment at first dose
- Positive for HIV, active hepatitis B or C with detectable viral load
- Pregnant or breastfeeding women
- Major surgery within 28 days or minor surgery within 7 days before first dose without adequate recovery
- Any other medical condition or lab abnormality that could affect safety or study assessments
- Planned use of prohibited medications during the study
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Atlantic Health
Morristown, New Jersey, United States, 07960
Actively Recruiting
2
Texas Oncology- Austin
Austin, Texas, United States, 78745
Actively Recruiting
3
Texas Oncology- Sammons- DFW
Dallas, Texas, United States, 75246
Actively Recruiting
4
The University of Texas M.D. Anderson Cancer Center GI Medical Oncology Dept
Houston, Texas, United States, 77030
Actively Recruiting
5
Texas Oncology- Northeast Texas
Tyler, Texas, United States, 75702
Actively Recruiting
6
Swedish
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
S
Sunil Sharma, MD
CONTACT
J
Jonathan Northrup
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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