A Study of THE-630 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

A Study of THE-630 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

Gastrointestinal Stromal Tumor

Active, not recruiting

1/2

Start Date 12/22/2021

Age of Trial (yrs) 2.9

Gleevec-resistant

KIT Inhibitor

Block KIT

Specifically GIST and only GIST

THE630-21-101

Theseus Pharmaceuticals

Theseus Pharmaceuticals 857-400-9491 ClinicalTrials@theseusrx.com

Oral

Theseus is no longer actively enrolling trial sites. Patients and caregivers can call the Theseus Clinical Trial Contact for information on pending sites4:52:26 PM

Theseus Pharmaceuticals 857-400-9491 ClinicalTrials@theseusrx.com


Detailed Description:

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 4 cohorts of patients with unresectable or metastatic GIST defined by prior therapy:

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 but have not received ripretinib (3rd-4th Line, ripretinib naive).
Cohort 3: Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, ripretinib and 0-1 additional lines of therapy in the advanced/metastatic setting (3rd-4th Line, ripretinib exposed)
Cohort 4: 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).

Key Exclusion Criteria: Patients known to be both KIT and PDGFRA wild-type

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.