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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am fully active or can carry out light work.
Select...
I can provide a sample of my tumor for testing.
Select...
My tumor cannot be removed by surgery and has spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Secondary outcome measures
ST316 Assessment DOR
ST316 Assessment Objective Response Rate (ORR)
ST316 Assessment Overall survival (OS)
+6 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Triple Negative Breast Cancer - Expansion phaseExperimental Treatment1 Intervention
Triple Negative Breast Cancer Expansion phase n=30
Group II: Ovarian CarcinomaExperimental Treatment1 Intervention
Ovarian Carcinoma - Expansion phase n=30
Group III: Dose Escalation PhaseExperimental Treatment1 Intervention
The dose cohorts will be 0.5, 1, 2, 4, and 8 mg/kg IV once weekly (QW)
Group IV: Colon Rectal Cancer (CRC) Expansion phaseExperimental Treatment1 Intervention
Expansion phase n=30
Group V: Cholangiocarcinoma - Expansion phaseExperimental Treatment1 Intervention
cholangiocarcinoma Expansion phase n=30
Find a Location
Who is running the clinical trial?
Sapience TherapeuticsLead Sponsor
1 Previous Clinical Trials
162 Total Patients Enrolled
Abi Vainstein-HarasStudy ChairCMO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's electrical activity (ECG) shows a prolonged QT interval.I am 18 years old or older.My doctor thinks standard treatments won't work for me or I've had bad reactions to cancer treatments.I am not currently receiving any cancer treatments.You have been diagnosed with HIV.I agree to have two biopsies: one before and one during the study.I am fully active or can carry out light work.I have active brain metastases or cancer in the lining of my brain.I have fluid buildup in my abdomen or around my lungs causing symptoms.I have another cancer that needs treatment besides the one being studied.You have a measurable disease according to RECIST 1.1 with at least one specific area that can be tracked for changes.I can provide a sample of my tumor for testing.You are allergic to ST316 or any of the ingredients in it.My tumor cannot be removed by surgery and has spread.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation Phase
- Group 2: Triple Negative Breast Cancer - Expansion phase
- Group 3: Colon Rectal Cancer (CRC) Expansion phase
- Group 4: Cholangiocarcinoma - Expansion phase
- Group 5: Ovarian Carcinoma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA granted its stamp of approval for Dose Escalation Phase?
"The safety of Dose Escalation Phase was rated a 1 due to its position as a phase 1 trial, meaning there is limited evidence demonstrating both efficacy and safety."
Answered by AI
Are there any active recruitment opportunities for this trial?
"Confirmed, the details provided by clinicaltrials.gov suggest that this study is not recruiting participants at present. The trial was initially posted on May 31st 2023 and last updated 28th April 2023. Even though this particular trial has closed its recruitment process, there are 1389 other trials actively searching for volunteers right now."
Answered by AI
Who else is applying?
What site did they apply to?
USC Norris Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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