FT-2102 in Patients with Advanced Solid Tumours and Gliomas
Research type
Research Study
Full title
A Phase 1b/2 Study of FT-2102 in Patients with Advanced Solid Tumors and Gliomas with an IDH1 Mutation
IRAS ID
248672
Contact name
Robin Jones
Contact email
Sponsor organisation
FORMA Therapeutics, Inc.
Eudract number
2018-001796-21
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 17 days
Research summary
Study 2102-ONC-102 is a phase 1b/2, open-label study of FT-2102 as a single agent and in combination with chemotherapy in patients with advanced solid tumours and gliomas with IDH1 mutation (a Basket study). This study will be conducted at clinical sites in the US, Canada, UK, Spain, France, Australia and South Korea. This study will enrol approximately 200 patients with confirmed IDH1 mutation across 4 disease-specific cohorts and 1 exploratory cohort in non-CNS solid tumours.
IDH1 inhibitors have been evaluated in clinical trials with demonstration of preliminary clinical activity. FT-2102 is a potent inhibitor or IDH1. Preliminary clinical results using FT-2102 have been positive and support further evaluation of FT-2102 in additional IDH1-mutated tumour types.This study is comprised of a Safety lead-in phase (phase 1b) to confirm the safety and tolerability of single-agent FT-2102 150 mg BID administered over 28 days (1 cycle).This will employ a traditional 3+3 design, where 3 patients with any of the specified solid tumours (Cohorts 2a-5a) or glioma (Cohort 1a) are treated with FT-2102 (150 mg BID) and monitored for dose-limiting toxicities (DLTs) during the first cycle of treatment. If no DLT, enrolment will continue into the disease specific cohorts. If there are more than 2 DLT, the dose will be reduced as determined by the Safety Review Committee (SRC). DLTs will also be evaluated within the first 3 (or 6) patients of any cohort examining combination therapy to confirm the safety and tolerability of combination therapy administered over 28 days (1 cycle) for Cohorts 1b to 4b using a 3+3 design. The cohort will be stopped if there is more than 1 DLT in the first 6 patients, and additional dose levels of either combination agent or FT-2102 will be evaluated following review by the SRC to determine the dose(s) to be used in the combination Phase 2.
Four disease-specific cohorts (Phase 2) will employ a stage-wise design, where 8 patients in the first stage of each cohort will be treated with study therapy (either single-agent FT-2102 or in combination with a chemotherapy agent) and evaluated for safety and efficacy.
Patient will participate for approximately 30 months and undergo assessments including; physical exams; blood sampling; tumour assessments etc., to see if the study drug or combination has an effect on their tumours.
REC name
Wales REC 2
REC reference
18/WA/0424
Date of REC Opinion
21 Feb 2019
REC opinion
Further Information Favourable Opinion