A Phase 2b, Multicenter, Open-Label, Dose-Escalation, and Randomized Dose-Optimization Study of Ofirnoflast (HT-6184) for the Treatment of Myelodysplastic Syndromes in Adults With Very Low- to Intermediate-Risk Myelodysplastic Syndromes Requiring Red Blood Cell Transfusions

Halia Therapeutics, Inc.

Summary

The primary objective of this study is to two part. First, dose selection for dose optimization based on safety of ofirnoflast. Second, to evaluate the efficacy of ofirnoflast administered in the study population. The secondary objectives of this study are to evaluate the extended hematologic response to ofirnoflast, to assess the safety and tolerability of ofirnoflast during dose optimization, and to evaluate hematologic improvement with ofirnoflast treatment.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * At least 18 years of age at the time of signing informed consent. * Capable of giving signed informed consent * Documented diagnosis of very low-, low-, or intermediate-risk MDS * Documented diagnosis of anemia * Documented low serum erythropoietin level * Relapsed or refractory disease after 1 to 3 prior lines of therapy for lower-risk MDS * Willing to provide a bone marrow aspirate at Screening. * Eastern Cooperative Group Performance Status (ECOG PS) of 0, 1, or 2 * Life expectancy of more than 6 months at screening. * Participants of childbearing potential must have…

Interventions

Drug
Ofirnoflast
tablet

Location

Cleveland Clinic
Cleveland, Ohio

A Phase 2b, Multicenter, Open-Label, Dose-Escalation, and Randomized Dose-Optimization Study of Ofirnoflast (HT-6184) for the Treatment of Myelodysplastic Syndromes in Adults With Very Low- to Intermediate-Risk Myelodysplastic Syndromes Requiring Red Blood Cell Transfusions

Summary

Eligibility

Interventions

Location

Compensation

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Details

Conditions