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

NCT07014449 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-06-11

No results posted yet for this study

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.

Conditions

  • AML (Acute Myelogenous Leukemia
  • Relapsed Acute Myelogenous Leukemia
  • Refractory Acute Myeloid Leukemia
  • Hematologic Malignancy
  • C-Myc
  • Adult Acute Myeloid Leukemia

Interventions

DRUG

WBC100 QD

WBC100 will be administered orally as capsules once daily in 28-day cycles. The dose-escalation phase follows an accelerated titration combined with the traditional '3+3' design.

Sponsors & Collaborators

  • Hangzhou Weben Pharma Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-03
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07014449 on ClinicalTrials.gov