The trial is taking place at:
D

Dana-Farber Cancer Institute | Pediatric Hematologic Malignancy

Veeva-enabled site

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

C

Cogent Biosciences

Status and phase

Enrolling
Phase 3

Conditions

Metastatic Cancer
Advanced Gastrointestinal Stromal Tumors

Treatments

Drug: CGT9486
Drug: Sunitinib
Drug: CGT9486 plus sunitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT05208047
CGT9486-21-301

Details and patient eligibility

About

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 426 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 at least one prior line of therapy for GIST and 2) evaluating for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 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.

Enrollment

426 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria: 1. Histologically confirmed locally advanced, metastatic, and/or unresectable GIST. Molecular pathology report must be available for Part 2; if molecular pathology report is unavailable or inadequate, an archival or fresh tumor tissue sample will be required to evaluate mutational status prior to randomization. 2. Documented disease progression on or intolerance to imatinib 3. Subjects must have received the following treatment: * Part 1a: Treatment with ≥1 prior lines of therapy for GIST * Part 1b: Treatment with ≥2 prior TKI for GISTs * Part 2: Prior treatment with imatinib only 4. Have at least 1 measurable lesion according to mRECIST v1.1 5. ECOG - 0 to 2 6. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits Key Exclusion Criteria: 1. Known PDGFR driving mutations or known succinate dehydrogenase deficiency 2. Clinically significant cardiac disease 3. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug 4. Gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption 5. Any active bleeding excluding hemorrhoidal or gum bleeding 6. Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody. 7. Active, uncontrolled, systemic bacterial, fungal, or viral infections at Screening 8. Received strong CYP3A4 inhibitors or inducers 9. Received sunitinib within 3 weeks (Part 1a, Part 1b)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

426 participants in 5 patient groups

Part 1a
Experimental group
Description:
CGT9486 plus sunitinib 37.5 mg QD
Treatment:
Drug: CGT9486 plus sunitinib
Part 2 - Experimental Group
Experimental group
Description:
CGT9486 plus sunitinib 37.5 mg QD
Treatment:
Drug: CGT9486 plus sunitinib
Part 2 - Control Group
Active Comparator group
Description:
sunitinib 37.5 mg QD
Treatment:
Drug: Sunitinib
Drug: Sunitinib
Part 1b - DDI Cohort 1
Experimental group
Description:
CGT9486 plus sunitinib 37.5 mg QD
Treatment:
Drug: CGT9486
Part 1b - DDI Cohort 2
Experimental group
Description:
sunitinib 37.5 mg QD plus CGT9486
Treatment:
Drug: Sunitinib
Drug: Sunitinib

Trial contacts and locations

125

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Central trial contact

Cogent Biosciences

Data sourced from clinicaltrials.gov

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