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
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).
Small molecule/tyrosine kinase inhibitors within 2 weeks
Any other systemic therapy for CRC within 3 weeks
Parallel
SR-8541A
DrugSR-8541A administered orally in combination with intravenous botensilimab and balstilimab
To evaluate the safety, tolerability, efficacy, and define the optimal dose for expansion of SR-8541A in combination with botensilimab and balstilimab
Part 1 of the study is to establish the recommended dose of SR-8541A in combination with botensilimab and balstilimab.
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