A Phase 1/1b, Multicenter, Open-label, Dose-Escalation Study of FT-2102 as a Single Agent and in Combination With Azacitidine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome With an IDH1 Mutation

This Phase 1/1b study will utilize a multicenter, open-label dose-escalation design to evaluate the safety, PK, and PD of FT-2102 (single agent) and FT-2102 + azacitidine (combination agent) administered via one or more intermittent dosing schedules. Approximately 48 patients will be enrolled in the dose-escalation portion of this study in one or more schedules followed by approximately 14 patients in expansion cohorts.

Cancer (Oncology), Cancer (Oncology) - Leukemia, Cancer (Oncology) - Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia
Raya Mawad, MD

Swedish Cancer Institute

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically proven acute myeloid leukemia or high risk or very high risk MDS as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R) that is either relapsed or refractory to standard therapy, or for whom standard treatments are contraindicated.
  • Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site
  • Good kidney and liver function
  • No prior organ allograft
  • For fertile men and women, agreement to use effective contraceptive methods duration of study participation and 90 days after

Exclusion Criteria:

  • Previously treated with any prior IDH1 targeted therapy
  • History of prior malignancy unless disease free for > 2 years.
  • Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy
  • Treatment with major surgery (requiring general anesthesia) within one month prior to study entry
  • Patients unable to swallow oral medications, or patients with gastrointestinal conditions (e.g. malabsorption, gastric or small bowel resection, etc.) deemed to jeopardize intestinal absorption
  • 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
  • Pulmonary disease (e.g. COPD, asthma, etc) that is not controlled (moderate to severe symptoms) with current medication
  • Known HIV positivity
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
(206) 215-3086