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An Open-label, Multicenter Phase 1 Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Splicing Modulator H3B-8800 for Subjects With Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia

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Trial Profile

An Open-label, Multicenter Phase 1 Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Splicing Modulator H3B-8800 for Subjects With Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 19 Feb 2024

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At a glance

  • Drugs H3B 8800 (Primary)
  • Indications Acute myeloid leukaemia; Chronic myelomonocytic leukaemia; Myelodysplastic syndromes
  • Focus Adverse reactions; First in man
  • Acronyms Encore-MDS
  • Sponsors H3 Biomedicine

Most Recent Events

  • 13 Feb 2024 According to a Roivant Sciences media release, the company has discontinued development of H3B-8800 (RVT-2001) after an interim data analysis from this trial.
  • 13 Feb 2024 Status changed from active, no longer recruiting to discontinued, According to a Roivant Sciences media release.
  • 13 Nov 2023 According to a Roivant Sciences media release, Hemavant plans to announce data from the ongoing open-label Phase 1/2 trial evaluating RVT-2001 for the treatment of transfusion-dependent anemia in lower-risk myelodysplastic syndromes (MDS) patients in the first quarter of calendar year 2024.

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