FindTrial
Sign In

CGT9486

DRUG5 trials

Sponsors

Cogent Biosciences Inc., Cogent Biosciences, Inc.

Conditions

Advanced Gastrointestinal Stromal TumorsAdvanced Systemic MastocytosisGastrointestinal Stromal TumorsMetastatic CancerNonadvanced Systemic Mastocytosisgastrointestinal stromal tumor

Phase 1

CGT9486 (Formerly Known as PLX9486) as a Single Agent and in Combination With PLX3397 (Pexidartinib) or Sunitinib in Participants With Advanced Solid Tumors
CompletedNCT02401815
Cogent Biosciences, Inc.Gastrointestinal Stromal Tumors
Start: 2015-03-06End: 2020-05-11Updated: 2025-02-14

Phase 2

(Summit) A Multi-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study of the Safety and Efficacy of CGT9486 in Subjects with NonAdvanced Systemic Mastocytosis
RecruitingCTIS2022-501427-24-00
Cogent Biosciences Inc.Nonadvanced Systemic Mastocytosis
Start: 2023-04-25Target: 150Updated: 2025-08-19
A Phase 2 Open-Label, Multicenter Clinical Study of The Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients with Advanced Systemic Mastocytosis
Active, not recruitingCTIS2024-511407-42-00
Cogent Biosciences Inc.Advanced Systemic Mastocytosis
Start: 2022-01-10Target: 60Updated: 2025-04-16

Phase 3

(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
Active, not recruitingNCT05208047
Cogent Biosciences, Inc.Advanced Gastrointestinal Stromal Tumors, Metastatic Cancer
Start: 2022-04-14End: 2026-09-01Target: 442Updated: 2026-02-04
(Peak) A Phase 3 Randomized, Open-label, Multicenter Clinical Study of CGT9486+Sunitinib vs Sunitinib in Subjects with Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors
Active, not recruitingCTIS2022-500637-80-00
Cogent Biosciences Inc.gastrointestinal stromal tumor
Start: 2023-03-28Target: 114Updated: 2025-08-06

Related Papers

SARC044: A phase II trial of bezuclastinib in combination with sunitinib in patients with GIST who progressed on sunitinib monotherapy.
Journal of Clinical Oncology2025-05-281 citations
Peak part 1 summary: A phase 3, randomized, open-label, multicenter clinical study of bezuclastinib (CGT9486) and sunitinib combination versus sunitinib in patients with gastrointestinal stromal tumors (GIST).
Journal of Clinical Oncology2025-01-271 citations
Peak part 1 summary: A phase 3, randomized, open-label multicenter clinical study of bezuclastinib (CGT9486) and sunitinib combination versus sunitinib in patients with gastrointestinal stromal tumors (GIST).
Journal of Clinical Oncology2024-06-011 citations
Peak study: A phase 3, randomized, open-label multi-center clinical study of bezuclastinib (CGT9486) and sunitinib combination versus sunitinib in patients with gastrointestinal stromal tumors (GIST).
Journal of Clinical Oncology2024-06-01
Peak study: A phase 3, randomized, open-label multicenter clinical study of bezuclastinib (CGT9486) and sunitinib in combination versus sunitinib in patients with gastrointestinal stromal tumors (GIST).
Journal of Clinical Oncology2024-01-202 citations
Safety, pharmacokinetics (PK), and clinical activity of bezuclastinib + sunitinib in previously-treated gastrointestinal stromal tumor (GIST): Results from part 1 of the phase 3 Peak study.
Journal of Clinical Oncology2023-06-016 citations
Association of Combination of Conformation-Specific KIT Inhibitors With Clinical Benefit in Patients With Refractory Gastrointestinal Stromal Tumors
JAMA Oncology2021-07-0837 citations
A phase I pharmacokinetic (PK) and pharmacodynamic (PD) study of PLX9486 alone and in combination (combo) with the KIT inhibitors pexidartinib (pexi) or sunitinib (su) in patients (Pts) with advanced solid tumors and gastrointestinal stromal tumor (GIST).
Journal of Clinical Oncology2018-05-208 citations