Phase 2 Study of SR-8541A in Combination With Botensilimab and Balstilimab in Subjects With Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC)
Stingray Therapeutics
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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 provid…
Interventions
- DrugSR-8541A
SR-8541A administered orally in combination with intravenous botensilimab and balstilimab
Locations (6)
- Atlantic HealthMorristown, New Jersey
- Texas Oncology- AustinAustin, Texas
- Texas Oncology- Sammons- DFWDallas, Texas
- The University of Texas M.D. Anderson Cancer Center GI Medical Oncology DeptHouston, Texas
- Texas Oncology- Northeast TexasTyler, Texas
- SwedishSeattle, Washington