NCT06589440 · Stingray Therapeutics
Phase 2 Study of SR-8541A in Combination With Botensilimab and Balstilimab in Subjects With Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC)
What this study is about
This is an where both patients and doctors know the treatment given, gradually increasing doses and expansion, multi-center phase 2 study evaluating the safety and effectiveness of SR-8541A administered taken by mouth in combination with given through a vein (IV) botensilimab and balstilimab in subjects with MSS-CRC with and without active liver metastases.
View original scientific description
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.
Interventions
DRUG
SR-8541A
SR-8541A administered orally in combination with intravenous botensilimab and balstilimab
Primary outcome measures
To evaluate the safety, tolerability, efficacy, and define the optimal dose for expansion of SR-8541A in combination with botensilimab and balstilimab
Time frame: Approximately 3 dose levels (DL) will be investigated in 28-day cycles
Part 1 of the study is to establish the recommended dose of SR-8541A in combination with botensilimab and balstilimab.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Written informed consent from subject 2. Age ≥ 18 years old on the date of consent 3. Histologically confirmed diagnosis of unresectable and metastatic adenocarcinoma of the colon or rectum 4. Non-microsatellite instability high or non-deficient mismatch repair (non-MSI-H/non-dMMR) tumor status per a standard local testing method 5. Must have received at least 1 prior chemotherapy regimen for metastatic or recurrent CRC 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 7. Measurable disease per RECIST v1.1 (Eisenhauer et al., 2009) 8. Able to provide archival or fresh tumor tissue during screening (required) and post-treatment (optional) 9. Adequate renal function defined as creatinine clearance ≥ 60mL/min 10. Adequate liver function 11. Adequate hematologic function 12. No growth factor support, transfusions, or albumin administration within 14 days of first dose of study treatment 13. Willing and able to comply with scheduled visits, treat
Where
- Morristown, New Jersey
- Austin, Texas
- Dallas, Texas
- Houston, Texas
- Tyler, Texas
- Seattle, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 15, 2026 · Source of record for eligibility and locations