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

NCT02401815 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-02-14

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Plexxikon

    collaborator INDUSTRY

  • Cogent Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Jessica Sachs, MD · Cogent Biosciences, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-06
Primary Completion
2020-05-11
Completion
2020-05-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02401815 on ClinicalTrials.gov