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.
Age range
18 Years
Sex
ALL
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Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Part 1: Recommended Phase 2 Dose (RP2D) of CGT9486
Timeframe: Cycle 1 of Part 1 (Cycle length = 28 days)
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Timeframe: From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days)
Part 1: Area Under The Concentration Time Curve From Time Zero to 24 Hours After Dosing (AUC0-24) of CGT9486
Timeframe: Predose, 1, 3, 5, 7, 9, and 24 hours postdose at Cycle 1 Day 1 and Cycle 1 Day 15
Part 1: Maximum Observed Plasma Concentration (Cmax) of CGT9486
Timeframe: Predose, 1, 3, 5, 7, 9, and 24 hours postdose at Cycle 1 Day 1 and Cycle 1 Day 15
Part 1: Time to Reach Cmax (Tmax) of CGT9486
Timeframe: Predose, 1, 3, 5, 7, 9, and 24 hours postdose at Cycle 1 Day 1 (Day -10 for 350 mg QD cohort) and Cycle 1 Day 15
Part 1: Half Life (T1/2) of PLX9486
Timeframe: Predose, 0.5, 1, 2, 4, 9, 24, 49, 72, 96, 120, 144, 168, 192, 216 hours postdose on Day -10
Part 2e: RP2D of CGT9486 in Combination With Sunitinib
Timeframe: Cycle 1 of Part 2e (Cycle length = 28 days)
Part 2b: RP2D of PLX9486 in Combination With Pexidartinib
Timeframe: Cycle 1 of Part 2 b (Cycle length = 28 days)
Part 2b: Number of Participants With Any TEAEs and Treatment-Related TEAEs
Timeframe: From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 868 days)
Part 2e: Number of Participants With Any TEAEs and Treatment-Related TEAEs
Timeframe: From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 825 days)