TRIAL DETAIL

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

Drug:
Trial Name:
A Study of THE-630 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Recruiting
Phase:
1/2
Start Date 12/22/2021
Age of Trial (yrs) .5
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT Inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
THE630-21-101
Sponsor:
Theseus Pharmaceuticals
Patient Contact:
Theseus Pharmaceuticals 857-400-9491 ClinicalTrials@theseusrx.com
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
Theseus is 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.

Trial Links

 

Trial Results

Drug Information

New IND announcement 11-1-2021 from Theseus
 
AACR 2021 Poster from Theseus
 
Theseus Corp Presentation 11/2021
 

Trial Sites

Name
Address
City
State
Zip
Country
450 Brookline Ave
Boston
MA
02215-5450
USA
3181 S.W. Sam Jackson Park Rd.
Portland
OR
97239
USA
1275 York Ave
New York
NY
10065
USA
10460 N. 92nd St.
Scottsdale
AZ
85258
USA