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RECRUITING Phase 1

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

NCT05848739 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG ST316
  • DRUG FOLFIRI regimen & bevacizumab
  • DRUG Fruquintinib
  • DRUG Lonsurf & bevacizumab

Study Locations (11)

Alabama

  • University of Alabama — Birmingham

California

  • USC Norris Comprehensive Cancer Center — Los Angeles

Colorado

  • Sarah Cannon Research Institute - CO — Denver

Louisiana

  • Ochsner Clinic Foundation — New Orleans

Massachusetts

  • Beth Israel Deaconess Medical Center — Boston

Michigan

  • START Midwest — Grand Rapids

New York

  • Westchester Medical Center — Valhalla

North Carolina

  • Duke Universtiy — Durham

Trial Details

FieldValue
Enrollment Target 130 participants
Start Date 2023-06-05
Est. Completion 2027-05-31
Phase Phase 1

Sponsor

Sapience Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05848739

The ClinicalTrials.gov registry entry for NCT05848739 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sapience Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Colon Cancer appearing as the primary indexed condition, and to 4 interventions — of which ST316 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05848739 reports 11 study locations spanning 11 distinct geographic areas — top geographies include Alabama, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05848739 about?

NCT05848739 is a clinical study titled "A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors". 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. Th...

What is the current status of trial NCT05848739?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 130 participants. The study started on 2023-06-05. Estimated completion is 2027-05-31.

What conditions does trial NCT05848739 study?

This clinical trial studies the following conditions: Colon Cancer, Metastatic Colon Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05848739?

The interventions under investigation include: ST316 (DRUG), FOLFIRI regimen & bevacizumab (DRUG), Fruquintinib (DRUG), Lonsurf & bevacizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05848739?

This trial is sponsored by Sapience Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05848739 being conducted?

This trial has 11 study locations across Alabama, California, Colorado, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial