NCT02401815

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

A Phase 1b and 2a Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CGT9486 as a Single Agent and in Combination With PLX3397 or Sunitinib (Sutent®) in Patients With Advanced Solid Tumors and Patients With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumor (GIST) Who Have Been Previously Treated With Imatinib Mesylate/KIT-Directed Tyrosine Kinase Inhibitor (TKI) Therapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Cogent Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study includes a dose escalation portion (Part 1) in which the safety profile and recommended phase 2 dose (RP2D) of CGT9486 as a single oral agent will be evaluated in participants with solid tumors (including GIST), followed by signal-seeking extension cohorts (Part 2). Enrollment in the combination treatment portions of the study (dose-finding for the CGT9486 + pexidartinib combination \[Part 2b\] and the CGT9486 + sunitinib combination \[Part 2e\]) is planned to be accrued using standard 3+3 study designs. Parts 2a, 2c, 2d, and 2f are not conducted due to business decisions.

Conditions

• Gastrointestinal Stromal Tumors

Interventions

Type	Name	Description
DRUG	CGT9486	CGT9486 will be administered per dose and schedule specified in the arm.
DRUG	Pexidartinib	Pexidartinib capsules will be administered per dose and schedule specified in the arm.
DRUG	Sunitinib	Sunitinib will be administered per dose and schedule specified in the arm.

Timeline

• Start date: 2015-03-06
• Primary completion: 2020-05-11
• Completion: 2020-05-11
• First posted: 2015-03-30
• Last updated: 2025-02-14
• Results posted: 2025-02-14

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study