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WNT/β-catenin signaling pathway inhibitor

ST316 for Advanced Cancers

Phase 1
Recruiting
Research Sponsored by Sapience Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status 0-1
Able to provide an archival tumor tissue sample for central lab analysis
Must not have
Concurrent anti-cancer therapy
Known active CNS metastases and/or carcinomatous meningitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new cancer drug to find if it's safe, how it works, and if it's effective against advanced solid tumors.

Who is the study for?
Adults (≥18 years) with various advanced solid tumors that are inoperable or have spread, and who haven't benefited from standard treatments or can't tolerate them. Participants must be able to provide tumor tissue samples, practice effective birth control if applicable, and have a performance status indicating they are relatively active.
What is being tested?
ST316 is being tested for safety and effectiveness against certain cancers likely affected by WNT/β-catenin pathway abnormalities. The trial has two parts: first to find the right dose of ST316, then to see how well it works at that dose.
What are the potential side effects?
Specific side effects of ST316 aren't listed but generally may include reactions at the infusion site, fatigue, digestive issues like nausea or diarrhea, changes in blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I can provide a sample of my tumor for testing.
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My tumor cannot be removed by surgery and has spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not currently receiving any cancer treatments.
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I have active brain metastases or cancer in the lining of my brain.
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I have fluid buildup in my abdomen or around my lungs causing symptoms.
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I have another cancer that needs treatment besides the one being studied.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Secondary study objectives
ST316 Assessment DOR
ST316 Assessment Objective Response Rate (ORR)
ST316 Assessment Overall survival (OS)
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: ST316 Monotherapy Colon Rectal Cancer (CRC) Expansion phaseExperimental Treatment1 Intervention
ST316 Monotherapy Colon Rectal Cancer (CRC) Expansion phase n=15-30
Group II: ST316 & Lonsurf + Bevacizumab Combination CRC Expansion phaseExperimental Treatment2 Interventions
ST316 \& Lonsurf \& bevacizumab n=15-30
Group III: ST316 & Fruquintinib Combination CRC Expansion phaseExperimental Treatment2 Interventions
ST316 \& Fruquintinib Combination CRC Expansion phase n=15-30
Group IV: ST316 & FOLFIRI/Bevacizumab Combination Colon Rectal Cancer (CRC) Expansion phaseExperimental Treatment2 Interventions
ST316 \& FOLFIRI/Bevacizumab Combination Colon Rectal Cancer (CRC) Expansion phase Expansion phase n=15-30
Group V: Dose Escalation PhaseExperimental Treatment1 Intervention
The dose cohorts will be 0.5, 1, 2, 4, 8 \& 12 mg/kg IV once weekly (QW)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fruquintinib
2021
Completed Phase 3
~1680

Find a Location

Who is running the clinical trial?

Sapience TherapeuticsLead Sponsor
1 Previous Clinical Trials
125 Total Patients Enrolled
Abi Vainstein-HarasStudy ChairCMO

Media Library

ST316 (WNT/β-catenin signaling pathway inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05848739 — Phase 1
Colon Cancer Research Study Groups: ST316 & FOLFIRI/Bevacizumab Combination Colon Rectal Cancer (CRC) Expansion phase, ST316 Monotherapy Colon Rectal Cancer (CRC) Expansion phase, ST316 & Lonsurf + Bevacizumab Combination CRC Expansion phase, ST316 & Fruquintinib Combination CRC Expansion phase, Dose Escalation Phase
Colon Cancer Clinical Trial 2023: ST316 Highlights & Side Effects. Trial Name: NCT05848739 — Phase 1
ST316 (WNT/β-catenin signaling pathway inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05848739 — Phase 1
~67 spots leftby May 2026
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