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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

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 weeks
Treatment ~ Varies
Follow Up ~up to 24 months after first dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months after first dose for reporting.

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): Recommended Phase 2 Dose (RP2D) of Orally Administered THE-630
Dose Escalation (Phase 1): Safety Analysis - Maximum Tolerated Dose (MTD) of Orally Administered THE-630
Dose Escalation (Phase 1): Safety Analysis - Number of Participants With Dose-limiting Toxicities (DLTs) Following Oral Administration of THE-630
+2 more
Secondary 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 more

Trial 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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Gastrointestinal Stromal Tumor (GIST) involve tyrosine kinase inhibitors (TKIs) such as imatinib, sunitinib, and regorafenib. These drugs target specific mutations in the KIT and PDGFRA genes, which are responsible for the abnormal activation of signaling pathways that drive tumor growth. By inhibiting these kinases, TKIs effectively reduce tumor proliferation and induce apoptosis. This is particularly important for GIST patients as these targeted therapies offer a more effective treatment option compared to conventional chemotherapy, especially for those with advanced or metastatic disease. Additionally, understanding the specific mutations in a patient's tumor can help tailor the treatment plan and manage resistance to therapy, improving overall outcomes.

Find a Location

Who is running the clinical trial?

Theseus PharmaceuticalsLead Sponsor
Stew KrollStudy DirectorTheseus Pharmaceuticals (a subsidiary of Concentra Biosciences)
5 Previous Clinical Trials
523 Total Patients Enrolled
David Kerstein, MDStudy DirectorTheseus Pharmaceuticals

Media Library

THE-630 (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05160168 — Phase 1 & 2
Gastrointestinal Stromal Tumor Research Study Groups: Expansion Cohort 1, Dose Escalation, Expansion Cohort 2, Expansion Cohort 3
Gastrointestinal Stromal Tumor Clinical Trial 2023: THE-630 Highlights & Side Effects. Trial Name: NCT05160168 — Phase 1 & 2
THE-630 (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05160168 — Phase 1 & 2
~9 spots leftby Jul 2025