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Kinase Inhibitor
THE-630 for Gastrointestinal Stromal Tumors
Phase 1 & 2
Waitlist Available
Research Sponsored by Theseus Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months after first dose
Awards & highlights
Study Summary
This trial will study a new drug for advanced gastrointestinal stromal tumors (GIST). The goal is to learn if it is safe and effective, and how it is metabolized by the body.
Who is the study for?
This trial is for adults with advanced gastrointestinal stromal tumors (GIST) who have not responded to or cannot tolerate certain treatments like imatinib, sunitinib, regorafenib, and others. Participants must be in good health otherwise, with no serious heart conditions or uncontrolled infections. Women of childbearing age and men with partners of childbearing potential must agree to use effective contraception.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of a drug called THE-630 on patients with GIST. It will also look at how the body processes the drug. The trial includes different phases where doses may vary based on patient response and side effects.See study design
What are the potential side effects?
While specific side effects for THE-630 are not listed here, common side effects from cancer drugs can include nausea, fatigue, diarrhea, risk of infection due to low blood cell counts, liver problems, skin reactions among others.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months after first dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months after first dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Escalation (Phase 1): RP2D of orally administered THE-630
Dose Escalation (Phase 1): Safety Analysis - MTD of orally administered THE-630
Dose Escalation (Phase 1): Safety Analysis - Number of participants with DLTs following oral administration of THE-630
+2 moreSecondary outcome measures
Dose Escalation (Phase 1): Efficacy Assessment - Best overall response, according to modified RECIST 1.1
Dose Escalation (Phase 1): Efficacy Assessment - Best target lesion response, according to modified RECIST 1.1
Dose Escalation (Phase 1): Efficacy Assessment - Clinical benefit rate (CBR) at 16 weeks, according to modified RECIST 1.1
+23 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Expansion Cohort 3Experimental Treatment1 Intervention
Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib (including in the adjuvant setting) and who have not received additional systemic therapy for advanced GIST, who will receive orally administered THE-630 at the recommended Phase 2 dose based on the dose escalation phase.
Group II: Expansion Cohort 2Experimental Treatment1 Intervention
Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib and 0-1 additional lines of therapy in the advanced/metastatic setting, who will receive orally administered THE-630 at the recommended Phase 2 dose based on the dose escalation phase.
Group III: Expansion Cohort 1Experimental Treatment1 Intervention
Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib, regorafenib and ripretinib who will receive orally administered THE-630 at the recommended Phase 2 dose based on the dose escalation phase.
Group IV: Dose EscalationExperimental Treatment1 Intervention
Participants with unresectable or metastatic GIST who will receive orally administered THE-630.
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Who is running the clinical trial?
Theseus PharmaceuticalsLead Sponsor
Stew KrollStudy DirectorTheseus Pharmaceuticals (a subsidiary of Concentra Biosciences)
4 Previous Clinical Trials
519 Total Patients Enrolled
David Kerstein, MDStudy DirectorTheseus Pharmaceuticals
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a heart condition called atrial arrhythmia that is not well controlled and may cause health problems.You have a history of irregular heartbeats in the lower chambers of the heart.You have tried and had a bad reaction to medications called imatinib, sunitinib, regorafenib, and ripretinib.You have experienced unstable chest pain within the past 6 months.You have tried imatinib therapy and it hasn't worked well or caused side effects. You have also received at least one of the following treatments: sunitinib, regorafenib, ripretinib, or avapritinib.You have tumors that have spread to your brain and have not been treated.You had a heart attack within the past 6 months before starting the study medication.You have had a stroke or mini-stroke within the 6 months before starting the study drug.You have any type of bleeding, except for bleeding from hemorrhoids or gums.You have experienced heart failure symptoms (like shortness of breath or fatigue) within the last 6 months.You have serious heart problems that are not being well controlled or are currently causing issues.You have either experienced worsening of your condition or have had difficulty tolerating imatinib treatment, including when used after surgery.You have not received any other medicine for advanced GIST (gastrointestinal stromal tumor).
Research Study Groups:
This trial has the following groups:- Group 1: Expansion Cohort 1
- Group 2: Dose Escalation
- Group 3: Expansion Cohort 2
- Group 4: Expansion Cohort 3
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.
How many centers is this clinical experiment overseen in?
"An array of medical centres are collaborating to make this trial a success, including Mayo Clinic Florida in Jacksonville, Massachusetts, Dana Farber Cancer Institute in Boston, Oregon and Oregon Health & Science University in Portland. In addition to these sites there are 7 other participating locations."
Answered by AI
What is the upper limit of participants for this exploration?
"To successfully conduct this study, Theseus Pharmaceuticals must recruit 140 patients that fulfill the inclusion criteria. For enrollment purposes, medical centres in Jacksonville, Massachusetts; and Boston, Oregon have been chosen."
Answered by AI
Are there any vacancies remaining for prospective participants of this clinical trial?
"Information uploaded to clinicaltrials.gov indicates that the trial is recruiting participants and has done so since its inception on March 1st 2022. The last recorded update was made on August 16th 2022."
Answered by AI
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