(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Leukemia Unknown Primary	NCT ID:	NCT05186753
Trial Phases:	Phase II	Protocol IDs:	CGT9486-21-202 (primary) NCI-2022-01167
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Cogent Biosciences, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05186753

Summary

This is a multi-part, randomized, double-blind, placebo-controlled Phase 2 clinical study
comparing the safety and efficacy of bezuclastinib (CGT9486) plus best supportive care
(BSC) with placebo plus BSC in patients with nonadvanced systemic mastocytosis
(NonAdvSM), including indolent systemic mastocytosis and smoldering systemic
mastocytosis, whose symptoms are not adequately controlled by BSC. This study will be
conducted in three parts. Patients in Parts 1a, 1b and 2 will receive bezuclastinib or
placebo, and may roll over onto Part 3 to receive treatment with bezuclastinib.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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