drugset / Trial / NCT07014449

Clinical Trial of WBC100 Capsule in Relapsed/Refractory Acute Myeloid Leukemia

NCT07014449 ↗

Phase 1 Recruiting 18 enrolled Hangzhou Weben Pharma Co., Ltd
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of WBC100 capsules in patients with relapsed or refractory acute myeloid leukemia (R/R AML). The main questions it aims to answer are: * What is the safety and tolerability profile of WBC100 in R/R AML patients? * Can WBC100 effectively induce remission in R/R AML patients? Participants will: * Take WBC100 capsules orally once daily in 28-day treatment cycles; * Undergo regular safety assessments, including adverse event monitoring and laboratory tests; * Provide blood samples for pharmacokinetic (PK) analysis; * Have their remission status and efficacy evaluated according to the ELN2022 criteria.

Timeline

Start
2024-11-03
Primary completion
2026-06
Completion
2026-06

Drugs

EvaluationDrugModalityDoseRoute
Subject WBC100 Unknown 0.5 mg Oral
Subject WBC100 Unknown 1 mg Oral
Subject WBC100 Unknown 1.5 mg Oral
Subject WBC100 Unknown 2 mg Oral
Subject WBC100 Unknown 2.5 mg Oral
Subject WBC100 Unknown 3 mg Oral