Patient case: 62-year-old male with cholangiocarcinoma; genetic feature: PIK3CA (1047H)

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

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.


Eligibility: 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

Relevance to patient case: not relevant