OncoMatch/Clinical Trials/NCT05848739
A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors
Is NCT05848739 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including ST316 and FOLFIRI regimen & bevacizumab for colon cancer.
Treatment: ST316 · FOLFIRI regimen & bevacizumab · Fruquintinib · Lonsurf & bevacizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
Subjects with RAS wild-type must have been treated with an anti-EGFR targeted agent during the first line of treatment.
Required: NRAS wild-type
Subjects with RAS wild-type must have been treated with an anti-EGFR targeted agent during the first line of treatment.
Allowed: BRCA1 mutation
Subjects with TNBC or OC with known BRCA mutations must have been previously treated with or intolerant to FDA approved treatments prior to enrolling in this study (e.g., iPARP).
Allowed: BRCA2 mutation
Subjects with TNBC or OC with known BRCA mutations must have been previously treated with or intolerant to FDA approved treatments prior to enrolling in this study (e.g., iPARP).
Allowed: MLH1 deficient mismatch repair
Subjects with CRC tumors that are MSI-H/dMMR must have received, refused or be intolerant to a checkpoint inhibitor (CPI).
Allowed: MSH2 deficient mismatch repair
Subjects with CRC tumors that are MSI-H/dMMR must have received, refused or be intolerant to a checkpoint inhibitor (CPI).
Allowed: MSH6 deficient mismatch repair
Subjects with CRC tumors that are MSI-H/dMMR must have received, refused or be intolerant to a checkpoint inhibitor (CPI).
Allowed: PMS2 deficient mismatch repair
Subjects with CRC tumors that are MSI-H/dMMR must have received, refused or be intolerant to a checkpoint inhibitor (CPI).
Disease stage
Metastatic disease required
Must have a locally advanced or metastatic inoperable tumor
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-EGFR targeted agent — first line (RAS wild-type) or first/second line (expansion phase cohorts 3/4)
Subjects with RAS wild-type must have been treated with an anti-EGFR targeted agent during the first line of treatment.
Must have received: checkpoint inhibitor — MSI-H/dMMR CRC
Subjects with CRC tumors that are MSI-H/dMMR must have received, refused or be intolerant to a checkpoint inhibitor (CPI).
Must have received: PARP inhibitor — BRCA-mutated TNBC or OC
Subjects with TNBC or OC with known BRCA mutations must have been previously treated with or intolerant to FDA approved treatments prior to enrolling in this study (e.g., iPARP).
Must have received: bevacizumab (bevacizumab) — OC
Subjects with OC must have been treated with, refused, or were ineligible for treatment with bevacizumab to enroll.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama · Birmingham, Alabama
- USC Norris Comprehensive Cancer Center · Los Angeles, California
- Sarah Cannon Research Institute - CO · Denver, Colorado
- Ochsner Clinic Foundation · New Orleans, Louisiana
- Beth Israel Deaconess Medical Center · Boston, Massachusetts
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