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

NCT05848739 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-05-11

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Sapience Therapeutics

    lead INDUSTRY

Principal Investigators

  • Abi Vainstein-Haras · CMO

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-05
Primary Completion
2026-05-31
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05848739 on ClinicalTrials.gov