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. The Phase 2 dose-expansion portion aims to continue to assess the safety of ST316 as well as proof of concept in four specific tumor types known to harbor abnormalities of the Wnt/β-catenin signaling pathway.

Sapience is actively enrolling patients in the Phase 1 portion of the study.

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 | Cholangiocarcinoma | Ovarian Cancer | Triple Negative Breast Cancer

Status

Recruiting Phase 1 Portion

Phase

Phase 1  |  Phase 2

ST316

Program Overview


ST316, a first-in-class antagonist of the interaction between β-catenin and its co-activator BCL9, is being evaluated in the Phase 1 portion of 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 is designed as a basket study to enroll patients with tumors likely to harbor abnormalities of the Wnt/β-catenin signaling pathway. The Phase 2 dose-expansion portion of the study will enroll patients in four specific tumor types known to harbor abnormalities of the Wnt/β-catenin signaling pathway, including cholangiocarcinoma, colorectal, triple negative breast and ovarian cancers.

Sapience is actively enrolling patients in the Phase 1 portion of the study.