At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b/2 Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
In Brief
A Phase 2 clinical trial evaluating FT-2102, Azacitidine, and 2 other interventions for Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme) and 4 related conditions. Completed, enrolled 93 participants across 26 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
FT-2102 will be supplied as a 150 mg capsule and will be administered per the protocol defined frequency and dose level.
Azacitidine will be administered per the site's standard of care.
Nivolumab will be administered per the site's standard of care.
Gemcitabine and cisplatin will be administered per the site's standard of care.