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
Sapience Therapeutics
130 participants
Jun 5, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
IV
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.
5 mg once a day for the first 21 days of a 28-day cycle
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
Locations(11)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05848739