NCT05848739

A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors

A Phase 1-2 Dose-escalation and Expansion Study of ST316 in Subjects With Selected Advanced Unresectable and Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Sapience Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, two-part, phase 1-2 study designed to determine the safety, tolerability, PK, pharmacodynamics (PD), and proof-of-concept efficacy of ST316 administered IV in subjects with selected advanced solid tumors likely to harbor abnormalities of the WNT/β-catenin signaling pathway. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.

Conditions

• Colon Cancer
• Metastatic Colon Cancer

Interventions

Type	Name	Description
DRUG	ST316	IV
DRUG	FOLFIRI regimen & bevacizumab	FOLFIRI: Days 1 and 15 of each 28-day cycle: * irinotecan 180 mg/m2 IV over 90 minutes concurrently with * leucovorin 400 mg/m2 IV over 2 hours, and then * 5-FU bolus 400mg/m2 (up to 15 min infusion) * 5-FU 2400 mg/m2 IV over 46 hours * bevacizumab should be administered as 5mg/kg.
DRUG	Fruquintinib	5 mg once a day for the first 21 days of a 28-day cycle
DRUG	Lonsurf & bevacizumab	Lonsurf 35 mg/m2 twice daily on days 1-5 and days 8-12 every 28 day bevacizumab 5 mg/kg on days 1 and 15. ST316

Timeline

• Start date: 2023-06-05
• Primary completion: 2026-05-31
• Completion: 2027-05-31
• First posted: 2023-05-08
• Last updated: 2025-05-11

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study