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

NCT03684811 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2023-11-18

Study results available
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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

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.

Sponsors & Collaborators

  • Forma Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Emma Barrett · Forma Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2021-05-24
Completion
2022-06-13
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • South Korea
  • Spain
  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03684811 on ClinicalTrials.gov