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.
As of July 2024, patient enrollment is complete in the Phase 1 portion of our ST316 Phase 1-2 clinical study. Recruitment of the Phase 2 expansion portion will begin in Summer 2024 in patients with colorectal cancer.
Eligibility
AGE:
18+
SEX:
ALL
Conditions
Phase 1 Dose Escalation:
Colorectal Cancer | Breast Cancer | Non-Small Cell Lung Cancer | Ovarian Cancer | Pancreatic Cancer | Melanoma | Cholangiocarcinoma | Synovial Sarcoma
Phase 2 Dose Expansion:
Colorectal Cancer
Status
Phase 1 Fully Enrolled
Phase
Phase 2-Ready
ST316
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. The Phase 1 dose-escalation portion of the study has 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 – the first indication to be assessed in the Phase 2 expansion, with recruitment commencing in Summer 2024.