(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors

(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors

Gastrointestinal Stromal Tumor

Recruiting

3

Start Date 04/14/2022

Age of Trial (yrs) 3

Gleevec-resistant

KIT inhibitor

Inhibit all resistant KIT/PDGFRa mutations

Specifically GIST and only GIST

CGT9486-21-301 Peak

Cogent Biosciences, Inc.

Cogent Biosciences 617-945-5576 peakinfo@cogentbio.com

Oral

PLEASE NOTE:

The PEAK trial has entered Part 2 which will accept only patients who have had prior Imatinib.

PATIENTS WHO HAVE TAKEN SUNITINIB ARE NOT ELIGIBLE.

Parts 1a and 1b are now closed to recruitment.

Only patients with KIT mutations are eligible. Patients with PDGFRa or SDH-deficient GIST are not eligible.

Brief Summary:

This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 388 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received multiple prior lines of therapy and 2) evaluating for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior lines of therapy. Parts 1a and 1b are now closed to recruitment.

Part 2 of the study will enroll up to 350 patients who are intolerant to, or who failed prior treatment with, imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner.

Partial Eligibility Criteria - Check full criteria in the NCT listing:

Key Inclusion Criteria:

Histologically confirmed locally advanced, metastatic, and/or unresectable GIST
Documented disease progression on or intolerance to imatinib
Have at least 1 measurable lesion according to mRECIST v1.1
ECOG - 0 to 2
Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits

Key Exclusion Criteria:

Prior treatment with < 2 Tyrosine Kinase Inhibitors (TKIs) (Part 1b only - Now closed)
Prior treatment with any TKI other than imatinib (Part 2 only)
Known PDGFR alpha D842V mutation or known succinate dehydrogenase deficiency ...
......