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

Conditions:Liver Cancer, Liver Cancer, Brain Cancer, Brain Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:November 1, 2018
End Date:April 1, 2022
Contact:Kathryn Lipford

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A Phase 1b/2 Study of FT 2102 in Participants With Advanced Solid Tumors and Gliomas With an IDH1 Mutation

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 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

- 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

- PD-1 only: active autoimmune disease
We found this trial at
1475 NW 12th Ave
Miami, Florida 33136
(305) 243-1000
Phone: 305-243-0865
University of Miami, Sylvester Comprehensive Cancer Center Sylvester Comprehensive Cancer Center integrates all cancer-related activities...
Miami, FL
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
Detroit, MI
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Iowa City, IA
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New Brunswick, New Jersey 08903
New Brunswick, NJ
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Salt Lake City, UT
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2401 South 31st Street
Temple, Texas 76508
Temple, TX
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