drugset / Trial / NCT02401815

CGT9486 (Formerly Known as PLX9486) as a Single Agent and in Combination With PLX3397 (Pexidartinib) or Sunitinib in Participants With Advanced Solid Tumors

NCT02401815

Phase 1/2 Completed 51 enrolled Cogent Biosciences, Inc. Plexxikon · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

The goal of this clinical research study is to learn how CGT9486 (fka PLX9486) may affect cancer cells with certain mutations in the KIT gene, specifically in participants with types of advanced solid tumors including gastrointestinal stromal tumor (GIST). CGT9486 (fka PLX9486) is designed to block KIT gene mutations. These mutations can cause cancer and cancer cell growth. By blocking these mutations, the drug may kill the cancer cells with the mutation and/or stop the tumor from growing. By combining CGT9486 (fka PLX9486) with PLX3397 and CGT9486 (fka PLX9486) with sunitinib, the investigators hope to block most KIT gene mutations that drive cancer growth.

Timeline

Start
2015-03-06
Primary completion
2020-05-11
Completion
2020-05-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Bezuclastinib Small molecule 250 mg Oral
Subject Bezuclastinib Small molecule 350 mg Oral
Subject Bezuclastinib Small molecule 500 mg Oral
Subject Bezuclastinib Small molecule 1000 mg Oral
Subject Pexidartinib Small molecule 600 mg Oral
Subject Sunitinib Small molecule 25 mg Oral
Subject Sunitinib Small molecule 37.5 mg Oral