FHD-286 in Subjects With Advanced Hematologic Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Hematologic Malignancy
- Refractory Acute Myeloid Leukemia
- Refractory Myelodysplastic Syndromes
- Relapsed Acute Myeloid Leukemia
- Relapsed Myelodysplastic Syndromes
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Open label single arm dose escalation in patients with advanced hematologic malignancies, specifically relapsed or refractory (R/R) acute myeloid leukemia (AML) or R/R myelodysplastic syndromes (MDS)Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This study is an ascending multiple dose escalation clinical trial. It is primarily intended to evaluate the safety and tolerability of FHD-286 when administered orally to subjects with advanced hematologic malignancies, specifically R/R AML and R/R MDS. This dose escalation study will allow for the...
This study is an ascending multiple dose escalation clinical trial. It is primarily intended to evaluate the safety and tolerability of FHD-286 when administered orally to subjects with advanced hematologic malignancies, specifically R/R AML and R/R MDS. This dose escalation study will allow for the determination of the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) of FHD-286 in patients with advanced hematologic malignancies. This study will also evaluate the PK/PD profiles of multiple dose administration of FHD-286 and provide a preliminary assessment of antitumor activity in subjects with R/R AML and R/R MDS as well as other associated hematologic malignancies. The data from this study in subjects with advanced hematologic malignancies, including safety, tolerability, PK/PD findings, and antitumor activity, will form the basis for subsequent clinical development of FHD-286.
Tracking Information
- NCT #
- NCT04891757
- Collaborators
- Syneos Health
- Investigators
- Study Director: Sarah Reilly, MD Foghorn Therapeutics
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