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A Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-108 as Monotherapy and in Combination With Azacitidine in Subjects With Relapsed or Refractory Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)

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Trial Profile

A Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-108 as Monotherapy and in Combination With Azacitidine in Subjects With Relapsed or Refractory Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 29 Apr 2024

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At a glance

  • Drugs Lacutoclax (Primary)
  • Indications Acute myeloid leukaemia; Chronic myelomonocytic leukaemia; Myelodysplastic syndromes
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Newave Pharmaceuticals

Most Recent Events

  • 23 Apr 2024 Status changed from recruiting to active, no longer recruiting.
  • 15 Jun 2023 Results (At data cut off Feb 20, 2023, n=32) assessing preliminary efficacy data of pts treated in an ongoing phase 1 study (NCT04139434)evaluating LP-108 as monotherapy (Arm 1) and in combination with azacitidine (Arm 2) in pts with relapsed orrefractory (r/r) MDS, CMML or AML presented at the 28th Congress of the European Haematology Association
  • 27 Mar 2023 Planned End Date changed from 1 Dec 2022 to 1 Jan 2025.

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