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NCT05848739 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Colon Cancer and Metastatic Colon Cancer, sponsored by Sapience Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
130
Enrollment target
11
Study locations

NCT05848739 is a Phase 1 study of Colon Cancer and Metastatic Colon Cancer that is actively recruiting participants, run by Sapience Therapeutics. The registered enrollment target is 130 participants, below the 4,455-participant average among 97 other Colon Cancer trials with a reported enrollment target (97% lower). The trial reports 11 study locations across 11 states.

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The verdict

NCT05848739, a Phase 1 study of Colon Cancer and Metastatic Colon Cancer, is actively recruiting participants, sponsored by Sapience Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
130 participants
Enrollment target
11
Study locations

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

What the Registry Record Tells You About NCT05848739

The ClinicalTrials.gov registry entry for NCT05848739 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,455-participant average among 97 other Colon Cancer trials with a reported enrollment target (97% lower). The listed sponsor is Sapience Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.

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.

NCT05848739 reports 11 study locations spanning 11 distinct geographic areas - top geographies include Alabama, California, Colorado.

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.

What interventions are being tested in trial NCT05848739?

The interventions under investigation include: ST316 (DRUG), FOLFIRI regimen & bevacizumab (DRUG), Fruquintinib (DRUG), Lonsurf & bevacizumab (DRUG).

Who is sponsoring clinical trial NCT05848739?

This trial is sponsored by Sapience Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.