A Phase 1-2 study of ST316 in patients with selected advanced unresectable and metastatic solid tumors
NCT05848739
Purpose of the Study
ST316-101 is an open-label, two-part study. The Phase 1 dose-escalation portion of the study is designed to determine the safety, tolerability, PK, and PD of ST316 in patients with selected advanced solid tumors likely to harbor abnormalities of the Wnt/β-catenin signaling pathway.
Recruitment of the Phase 2 dose expansion study is underway in patients with colorectal cancer.
Eligibility
AGE:
18+
SEX:
ALL
Conditions
Colorectal Cancer
Status
Enrolling Patients
Phase
Phase 2 Dose Expansion
Program Overview
ST316, a first-in-class antagonist of the interaction between β-catenin and its co-activator BCL9, is being evaluated in a Phase 1-2 clinical study in patients with selected advanced unresectable and metastatic solid tumors.
ST316-101 (NCT05848739) is an open-label, two-part, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD and proof-of-concept efficacy of ST316 in patients with advanced solid tumors likely to harbor abnormalities of the Wnt/β-catenin signaling pathway. In July 2024, the Phase 1 dose-escalation portion of the study completed enrollment of patients with tumors likely to harbor abnormalities of the Wnt/β-catenin signaling pathway.
The Wnt/β-catenin signaling pathway drives more than 80% of colorectal cancers (CRCs). A Phase 2 dose expansion study is currently recruiting CRC patients in combination with standard of care across multiple treatment lines.