Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
Participants in this trial will be recruited according to the following classifications - Cohort 1a and 1b: Glioma Cohort 1a and 1b: 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 Solid Tumors With IDH1 Mutations. All participants in Cohorts 1a-5a will receive FT-2102 as a 150mg capsule, administered as per the protocol defined frequency and dose. In Cohorts 1b and 3b, Azacitidine will also be administered, as per site's standard of care (SOC). In Cohort 2b Nivolumab will be administered as per the site's SOC, in addition to FT-2102. Participants in Cohort 4b will receive Gemcitabine and Cisplatin will be administered per site's SOC in addition to FT-2102.
Conditions
This trial is treating people with advanced solid cancers and gliomas with an IDH1 Mutation
Eligibility
Inclusion
- 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
- 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
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Forma Therapeutics, Inc.
Scientific Title
A Phase 1b/2 Study of FT 2102 in Participants With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information