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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: Recruiting Phase 1 study of Colon Cancer and Metastatic Colon Cancer, sponsored by Sapience Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2023-06-05 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 1 |
What NCT05848739 shows while recruiting
NCT05848739 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 4,455-participant average among 97 other Colon Cancer trials with a reported enrollment target (97% lower).
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 lists 11 locations in 11 states (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.
Learn More About Clinical Trials
Similar trials for Colon Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05848739's enrollment target sits among peer trials
130 45th of 97 higher than 53 of 97 other Colon Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colon Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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