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