NCT03684811

A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation

A Phase 1b/2 Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Forma Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas. The study is divided into two parts: single agent FT-2102 followed by combination therapy. Part 1: A single agent, open-label study in up to five cohorts (glioma, hepatobiliary tumors, chondrosarcoma, intrahepatic cholangiocarcinoma, and other IDH1 mutant solid tumors) that will include a Phase 1 dose confirmation followed by a Phase 2 investigation of clinical activity in up to 4 cohorts. During the dose confirmation, additional doses or altered dose schedules may be explored. Part 2: An open-label study of FT-2102 in combination with other anti-cancer agents. Patients will be enrolled across 4 different disease cohorts, examining the effect of FT-2102 + azacitidine (glioma and chondrosarcoma), FT-2102 + nivolumab (hepatobiliary tumors), and FT-2102 + gemcitabine/cisplatin (intrahepatic cholangiocarcinoma). There will be a safety lead-in followed by a Phase 2 evaluation in up to four cohorts of patients.

Conditions

• Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme)
• Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas)
• Cohort 3a and 3b: Chondrosarcoma
• Cohort 4a and 4b: Intrahepatic Cholangiocarcinoma
• Cohort 5a: Other Non-Central Nervous System Solid Tumors With IDH1 Mutations

Interventions

Type	Name	Description
DRUG	FT-2102	FT-2102 will be supplied as a 150 mg capsule and will be administered per the protocol defined frequency and dose level.
DRUG	Azacitidine	Azacitidine will be administered per the site's standard of care.
BIOLOGICAL	Nivolumab	Nivolumab will be administered per the site's standard of care.
DRUG	Gemcitabine and Cisplatin	Gemcitabine and cisplatin will be administered per the site's standard of care.

Timeline

• Start date: 2018-11-01
• Primary completion: 2021-05-24
• Completion: 2022-06-13
• First posted: 2018-09-26
• Last updated: 2023-11-18
• Results posted: 2023-01-25

Locations

26 sites across 6 countries: United States, Australia, France, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study