This study will assess the safety, efficacy, and pharmacokinetics of THE-630 in participants
with advanced gastrointestinal stromal tumors (GIST).
The drug being tested in this study is called THE-630, an orally administered KIT tyrosine
kinase inhibitor. The study will be conducted in two parts: a dose escalation phase, followed
by an expansion phase. The patient population of the initial dose escalation phase (Phase 1)
of the trial will include patients with unresectable or metastatic GIST. Patients must have
disease progression on or be intolerant to imatinib therapy and have also received at least 1
of the following: sunitinib, regorafenib, ripretinib, or avapritinib. The primary objective
of the dose escalation phase is to determine the safety profile of oral THE-630, including
the dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and the recommended phase
2 dose (RP2D).
Once a recommended dose has been determined in the escalation phase, the expansion phase
(Phase 2) will enroll 3 cohorts of patients with unresectable or metastatic GIST defined by
Cohort 1: Patients with unresectable or metastatic GIST who have progressed on or are
intolerant to imatinib, sunitinib, regorafenib and ripretinib (≥5th Line).
Cohort 2: 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 (3rd-4th Line).
Cohort 3: 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 (2nd Line).
The safety and tolerability of orally administered THE-630 will continue to be assessed in
the expansion cohorts. However, the primary objective of the expansion component of the trial
is to evaluate the anti-tumor activity of THE-630 in these GIST patient populations.
Gastrointestinal Stromal Tumors (GIST), Neoplasms, Connective Tissue, Neoplasms, Connective and Soft Tissue, Neoplasms by Histologic Type, Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasm, Digestive System Disease, Gastrointestinal Diseases
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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