drugset
drugset / Trial / NCT04139434

Dose-Escalation Study of Oral Administration of LP-108 as Monotherapy and in Combination With Azacitidine in Patients With Relapsed or Refractory MDS, CMML, or AML

NCT04139434 ↗

Phase 1 Completed 32 enrolled Newave Pharmaceutical Inc
Non-randomizedSequentialOpen-labelTreatment

Summary

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)

Timeline

Start
2020-07-06
Primary completion
2025-12-19
Completion
2025-12-19

Drugs

EvaluationDrugModalityDoseRoute
Subject LP-108 Unknown 100 mg Oral
Subject LP-108 Unknown 200 mg Oral
Subject LP-108 Unknown 400 mg Oral
Subject LP-108 Unknown 600 mg Oral
Subject LP-108 Unknown 800 mg Oral
Subject LP-108 Unknown 1000 mg Oral
Background Azacitidine Other / unclassified 75 mg/m2 —

Indications

acute lymphoblastic leukemia acute myeloid leukemia chronic myelomonocytic leukemia