NCT05848739

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

Recruiting now Phase 1 Last updated 11 May 2025

What this trial tests

Phase 1 trial testing ST316 in Colon Cancer in 130 participants. Currently enrolling.

Timeline

5 June 2023

Primary endpoint
31 May 2026

31 May 2027

Quick facts

Lead sponsor	Sapience Therapeutics
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	130
Start date	5 June 2023
Primary completion	31 May 2026
Estimated completion	31 May 2027
Sites	11 locations across United States

Drugs / interventions tested

• ST316 — full drug profile →
• FOLFIRI regimen & bevacizumab — full drug profile →
• Fruquintinib — full drug profile →
• Lonsurf & bevacizumab — full drug profile →

Conditions studied

• Colon Cancer — all drugs for Colon Cancer →
• Metastatic Colon Cancer — all drugs for Metastatic Colon Cancer →

Sponsor

Sapience Therapeutics — full company profile →

Who can join

18 and older, any sex, with Colon Cancer or Metastatic Colon Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Wnt signaling pathways in biology and disease: mechanisms and therapeutic advances.
   Xue C, Chu Q, Shi Q, Zeng Y, et al · · 2025 · cited 103× · PMID 40180907 · DOI 10.1038/s41392-025-02142-w
2. Wnt signaling in cancer: from biomarkers to targeted therapies and clinical translation.
   Tufail M, Jiang CH, Li N. · · 2025 · cited 36× · PMID 40170063 · DOI 10.1186/s12943-025-02306-w
3. Exploring the Impact of the β-Catenin Mutations in Hepatocellular Carcinoma: An In-Depth Review.
   Idrissi YA, Rajabi MR, Beumer JH, Monga SP, et al · · 2024 · cited 13× · PMID 39428608 · DOI 10.1177/10732748241293680
4. Targeted Therapy for Highly Desmoplastic and Immunosuppressive Tumor Microenvironment of Pancreatic Ductal Adenocarcinoma.
   Olaoba OT, Yang M, Adelusi TI, Maidens T, et al · · 2024 · cited 13× · PMID 38672552 · DOI 10.3390/cancers16081470
5. Clinical applications of circulating tumor cells in metastasis and therapy.
   Yang C, Liu C, Xia C, Fu L. · · 2025 · cited 7× · PMID 40846962 · DOI 10.1186/s13045-025-01733-y
6. Wnt Pathway-Targeted Therapy in Gastrointestinal Cancers: Integrating Benchside Insights with Bedside Applications.
   Nayak A, Streiff H, Gonzalez I, Adekoya OO, et al · · 2025 · cited 6× · PMID 39936971 · DOI 10.3390/cells14030178
7. Therapeutic Potential of Natural Compounds to Modulate WNT/β-Catenin Signaling in Cancer: Current State of Art and Challenges.
   Gajos-Michniewicz A, Czyz M. · · 2024 · cited 5× · PMID 39684513 · DOI 10.3390/ijms252312804
8. Targeted protein degradation of Wnt/β-catenin signaling pathway: an effective strategy for cancer therapy.
   Mao S, Zhang X, Zhao Y, Li X, et al · · 2025 · cited 4× · PMID 41199284 · DOI 10.1186/s12967-025-07333-1