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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• FT-2102 — DRUG
  FT-2102 will be supplied as a 150 mg capsule and will be administered per the protocol defined frequency and dose level.
• Azacitidine — DRUG
  Azacitidine will be administered per the site's standard of care.
• Nivolumab — BIOLOGICAL
  Nivolumab will be administered per the site's standard of care.
• Gemcitabine and Cisplatin — DRUG
  Gemcitabine and cisplatin will be administered per the site's standard of care.

Study Details

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.

Key Dates

Start date

Nov 1, 2018

Status verified

Nov 2023

Primary completion

May 24, 2021

Completion

Jun 13, 2022

Study Design

Enrollment

93 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1b Dose Confirmation Single Agent (Cohorts 1a-5a)
• Experimental: Phase 2 Cohorts FT-2102 Single Agent (Cohorts 1a-5a)
• Experimental: Phase 1b and 2 Cohorts Combination (Cohorts 1b and 3b)
• Experimental: Phase 1b and 2 Cohort Combination (Cohort 2b)
• Experimental: Phase 1b and 2 Cohort Combination (Cohort 4b)

Primary Outcome Measure

Number of Participants With a Dose Limiting Toxicity (DLT) [ Time Frame: Day 1-28 ]

Locations (14)

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