Phase 2 Study of SR-8541A in Combination With Botensilimab and Balstilimab in Subjects With Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC)
Recruiting now · Phase 2
Conditions studied: Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC)
In brief
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.
Key facts
- Study ID
- NCT06589440
- Run by
- Stingray Therapeutics
- People needed
- 70
- Starts
- 2024-11-20
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2026-01-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Written informed consent from subject
- Age ≥ 18 years old on the date of consent
- Histologically confirmed diagnosis of unresectable and metastatic adenocarcinoma of the colon or rectum
- Non-microsatellite instability high or non-deficient mismatch repair (non-MSI-H/non-dMMR) tumor status per a standard local testing method
- Must have received at least 1 prior chemotherapy regimen for metastatic or recurrent CRC
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Measurable disease per RECIST v1.1 (Eisenhauer et al., 2009)
- Able to provide archival or fresh tumor tissue during screening (required) and post-treatment (optional)
- Adequate renal function defined as creatinine clearance ≥ 60mL/min
- Adequate liver function
- Adequate hematologic function
- No growth factor support, transfusions, or albumin administration within 14 days of first dose of study treatment
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- Male and female subjects of childbearing potential must agree to use a highly medically effective method of contraception and refrain from sperm/egg donation throughout the study starting with the first dose of study treatment (or 14 days prior to the first dose of study treatment for oral contraception) and for at least 3 months after the last dose of study treatment
You may not qualify if…
- Hypersensitivity or allergy to any of the study drugs or their excipients.
- In Part 2, Cohort A, active liver metastases by computed topography (CT) or magnetic resonance imaging (MRI).
- Treatment with one of the following classes of drugs within the delineated time window prior to first dose:
- Small molecule/tyrosine kinase inhibitors within 2 weeks
- Any other systemic therapy for CRC within 3 weeks
- Received another investigational drug within 30 days or active participation in another clinical trial (follow-up is permitted)
- Medications/products which are known strong inhibitors or inducers of the CYP enzymes within 5 x T1/2
- Received programmed cell death protein 1, PD-(L)1, or CTLA-4 therapies including any immune checkpoint inhibitor or experimental immunologic agents.
- Partial or complete bowel obstruction within the last 3 months, signs/symptoms of bowel obstruction, or known radiologic evidence of impending obstruction.
- Refractory ascites.
- Current evidence of interstitial lung disease (ILD) or pneumonitis, or prior history of ILD or non-infectious pneumonitis requiring glucocorticoids.
- Continuous systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 28 days prior to Day 1.
- Active autoimmune disease that has required systemic treatment in past 2 years
- Patients with adrenal / pituitary insufficiency
- History of documented congestive heart failure; unstable angina; poorly controlled hypertension; clinically significant valvular heart disease; high-risk uncontrolled arrhythmias (including sustained ventricular tachycardia); myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within the last 6 months, or Canadian Cardiovascular Society angina class > 2
- History of allogeneic organ transplant, stem cell transplant, or bone marrow transplant
- Previous SARS-CoV-2 infection within 10 days for mild or asymptomatic infections or 20 days for severe/critical illness prior to first dose
- Requirement for treatment with strong cytochrome P450 3A4 inducers or inhibitors
- Presence of gastrointestinal condition, for example, malabsorption, that might affect the absorption of Investigational Product(s).
- Troponin I > ULN
- Uncontrolled hypertension
- Corrected QT interval by Fridericia (QTcF) ≥ 470 ms per the central mean average of triplicate electrocardiograms (ECGs)
- Left Ventricular Ejection Fraction (LVEF) < 50% using echocardiogram or multigated acquisition (MUGA)
- Symptomatic uncontrolled central nervous system (CNS) disease requiring treatment with steroids or anti-seizure medications within 2 months prior to Day 1. However, subjects with brain metastases that have been previously treated and are stable based on imaging performed within 2 months of Day 1 following completion of any CNS-directed therapy are allowed
- Leptomeningeal disease
Where it is running
- Atlantic Health — Morristown, New Jersey, United States (enrolling)
- Texas Oncology- Austin — Austin, Texas, United States (enrolling)
- Texas Oncology- Sammons- DFW — Dallas, Texas, United States (enrolling)
- The University of Texas M.D. Anderson Cancer Center GI Medical Oncology Dept — Houston, Texas, United States (enrolling)
- Texas Oncology- Northeast Texas — Tyler, Texas, United States (enrolling)
- Swedish — Seattle, Washington, United States (enrolling)
Full record on ClinicalTrials.gov
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