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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 (including: 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

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, and uncontrolled diabetes) - Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy - PD-1 only: active autoimmune disease

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1b Dose Confirmation Single Agent (Cohorts 1a-5a)
  • 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.
Experimental
Phase 2 Cohorts FT-2102 Single Agent (Cohorts 1a-5a)
  • 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.
Experimental
Phase 1b and 2 Cohorts Combination (Cohorts 1b and 3b)
  • 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.
    Other names:
    • Vidaza
Experimental
Phase 1b and 2 Cohort Combination (Cohort 2b)
  • 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.
  • Biological: Nivolumab
    Nivolumab will be administered per the site's standard of care.
    Other names:
    • Opdivo
Experimental
Phase 1b and 2 Cohort Combination (Cohort 4b)
  • 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: Gemcitabine and Cisplatin
    Gemcitabine and cisplatin will be administered per the site's standard of care.
    Other names:
    • Gemzar and Platinol

More Details

Status
Completed
Sponsor
Forma Therapeutics, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.