A Study of DCC-3116 in Combination with Anticancer Therapies in Participants with Advanced Malignancies

A Study of DCC-3116 in Combination with Anticancer Therapies in Participants with Advanced Malignancies

Gastrointestinal Stromal Tumor

Recruiting

1/2

Start Date 09/28/2023

Age of Trial (yrs) 2.5

Gleevec-resistant

ULK1/2 inhibitor + KIT inhibitor

Block ASR autophagy activation + Block KIT

Specifically GIST and only GIST

DCC-3116-01-002

Deciphera

Clinical Team 785-830-2100 Clinicaltrials@deciphera.com

Oral

Eligibility Criteria (Partial: see NCT listing for full inclusion/exclusion criteria)

Inclusion Criteria:

Male or female ≥18 years of age
Module A: Part 1 and Part 2:

Module A Part 1 and Part 2 DCC-3116 combination closed on January 8, 2024, with no participants enrolled.

Module B: Only for Part 1 (Safety/Dose-finding):
Pathologically confirmed diagnosis of GIST with a KIT or platelet-derived growth factor receptor alpha (PDGFRA) mutation
Must have progressed on at least one approved systemic regimen given in the locally advanced or metastatic setting or have documented intolerance to it
Must not have received prior ripretinib treatment

Module B: Only for Part 2 (Expansion)
Pathologically confirmed GIST with documented mutation in KIT exon 11
Must have progressed on imatinib given in the locally advanced or metastatic setting or have been intolerant to imatinib and may not have received additional systemic therapy for GIST
Must have at least 1 measurable lesion according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Must have a life expectancy of more than 3 months and an ECOG performance status of 0-1
Adequate organ function and bone marrow reserve based on laboratory assessments performed at Screening
Must provide a fresh tumor biopsy if able.