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2102-HEM-101: A Phase 1/2, multi-center, open-label study of FT-2102 as a single agent and in combination with azacitidine or cytarabine in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) with an IDH1 mutation

Description

This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into two parts: a dose escalation part, which will utilize an open-label design of FT-2102 (single agent) and FT-2102 + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to five expansion cohorts, exploring single-agent FT-2102 activity as well as combination activity with azacitidine or cytarabine. Following the completion of Phase 1, Phase 2 will begin enrollment. Patients will be enrolled across six different cohorts, examining the effect of FT-2102 (as a single agent) and FT-2102 + azacitidine (combination) on various AML/MDS disease states.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of Phase 1 is to determine the maximum tolerated doses or the maximum evaluated doses, dose-limiting toxicities and the Phase 2 dose(s) of FT-2102 as a single agent in combination with azacitidine, and in combination with cytarabine in patients with AML or MDS, harboring the IDH1-R132 mutation.

The primary objective of Phase 2 is to evaluate the anti-leukemic and anti-myelodysplastic activity of FT-2102 as a single agent or in combination with azacitidine in patients with AML or MDS, harboring an IDH1-R132 mutation.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Have pathologically proven acute myeloid leukemia or intermediate, high-risk, or very high- risk myelodysplastic syndrome as defined by the World Health Organization criteria or Revised International Prognostic Scoring System, which is relapsed or refractory to standard therapy and/or for which standard therapy is contraindicated or which has not adequately responded to standard therapy
  • Have documented IDH1-R132 gene-mutated disease as evaluated by the site
  • Have good performance status
  • Have good kidney and liver function

Excluding patients who:

  • Have symptomatic central nervous system (CNS) metastases or other tumor location, such as spinal cord compression, other compressive mass, uncontrolled painful lesion or bone fracture, necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy
  • Have congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris (Previous history of myocardial infarction within one year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias)
  • Have pulmonary disease, such as COPD or asthma, that is not controlled (moderate to severe symptoms) with current medication
  • Have active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
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