A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
Completed · Phase 1/Phase 2
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT03684811
- Run by
- Forma Therapeutics, Inc.
- People needed
- 93
- Starts
- 2018-11-01
- Expected to finish
- 2022-06-13
- Last updated by the study team
- 2023-11-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Banner MD Anderson — Gilbert, Arizona, United States
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
- University of Miami, Sylvester Comprehensive Cancer Center — Miami, Florida, United States
- Northwestern University, Lurie Comprehensive Cancer Center — Chicago, Illinois, United States
- University of Iowa, Holden Comprehensive Cancer Institute — Iowa City, Iowa, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
- Columbia University Medical Center — New York, New York, United States
- Baylor Scott and White Medical Center — Temple, Texas, United States
- University of Utah, Huntsman Cancer Hospital — Salt Lake City, Utah, United States
- Medical College of Wisconsin, Froedtert Hospital — Milwaukee, Wisconsin, United States
- Austin Hospital — Heidelberg, Victoria, Australia
- Peter MacCallum Cancer Centre — Melbourne, Australia
- Centre de Lutte Contre Cancer (CLCC) - Institute Bergonie — Bordeaux, France
- Centre de Lutte Cancre (CLCC) - Lyon — Lyon, France
- Hospital de la Timone — Marseille, France
- Institut Gustave Roussy Cancer Campus — Villejuif, France
- Seoul National University Hospital — Seoul, South Korea
- Asan Medical Center — Seoul, South Korea
- Samsung Medical Center — Seoul, South Korea
- Vall D'Hebron University Hospital — Barcelona, Spain
- Cancer Research Beatson Institute — Glasgow, United Kingdom
Full record on ClinicalTrials.gov
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