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

• Status: Active, not recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forma Therapeutics, Inc.
• Treatments: Azacitidine; Cisplatin; Gemcitabine; Nivolumab

Criteria

Key Inclusion Criteria:

• Patients must have documented IDH1-R132 gene-mutated disease as evaluated by site

• Glioma: Advanced glioma that has recurred or progressed following standard therapy, or that has not responded to standard therapy.

• Hepatobiliary cancer that is relapsed/refractory or intolerant to approved standard-of-care therapy (included: hepatocellular carcinoma, bile duct carcinoma, intrahepatic cholangiocarcinoma or other hepatobiliary carcinomas)

• Chondrosarcoma that is relapsed or refractory and either locally advanced or metastatic and not amenable to complete surgical excision

• Intrahepatic cholangiocarcinoma that is advanced nonresectable or metastatic cholangiocarcinoma not eligible for curative resection or transplantation. Phase 1b/Safety Lead-in of Phase 2: relapsed or refractory disease. Combination Phase 2 (beyond Safety Lead-in): have received no more than 1 cycle of gemcitabine/cisplatin therapy

• Other solid tumors that have relapsed or refractory to standard-of-care therapy with no other available therapeutic options

• Good performance status

• Good kidney and liver function

Key Exclusion Criteria:

• Prior solid organ or hematopoietic cell transplant

• Prior treatment with IDH1 inhibitor (Single agent cohorts only)

• Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris. Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias

• Unstable or severe, uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition including pneumonitis and/or interstitial lung disease, uncontrolled diabetes)

• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy

• PD-1 only: active autoimmune disease