Trials / Recruiting
RecruitingNCT07014449
Clinical Trial of WBC100 Capsule in Relapsed/Refractory Acute Myeloid Leukemia
An Open-Label, Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy of WBC100 Capsules in Patients With Relapsed or Refractory Acute Myeloid Leukemia
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- Sponsor
- Hangzhou Weben Pharma Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-11-03
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2025-06-11
- Last updated
- 2025-06-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07014449. Inclusion in this directory is not an endorsement.