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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 1\. Signed informed consent and compliance with study procedures;

• 2\. Male or female participants aged ≥18 years at the time of consent;

• 3\. Diagnosis of relapsed or refractory acute myeloid leukemia (R/R AML) according to the 2016 World Health Organization (WHO) classification;

• 4\. ECOG PS 0-2;

• 5\. Life expectancy ≥3 months;

• 6\. Adequate bone marrow reserve and organ function as defined below:

‣ Bone marrow reserve: Peripheral WBC \< 25 × 10⁹/L (leukocyte-reducing agents are allowed, with a washout period of at least 5 half-lives prior to study drug administration);

⁃ Coagulation: International normalized ratio (INR) ≤ 2;

⁃ Hepatic function: Total bilirubin (TBIL) ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN. In cases of hepatic involvement: ALT or AST ≤ 5 × ULN, and TBIL ≤ 3 × ULN;

⁃ Renal function: Creatinine clearance ≥60 mL/min (Cockcroft-Gault), or serum creatinine ≤1.5 × ULN;

⁃ Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%; QTcF ≤450 ms for males, ≤470 ms for females.

• 7\. Female participants of childbearing potential and fertile male participants with partners of childbearing potential must use medically approved contraception during treatment and for 6 months after the final dose.

Locations
Other Locations
China
The First Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Biao Zhang, Ph.D.
bzhang@webenpharma.com
+86 13989822331
Backup
Baorui Kong, M.Med.
brkond@webenpharma.com
+86 17335563516
Time Frame
Start Date: 2024-11-03
Estimated Completion Date: 2026-06
Participants
Target number of participants: 18
Treatments
Experimental: WBC100 Capsules
Participants will take WBC100 capsules orally once daily in 28-day cycles. This arm includes a dose-escalation phase using an accelerated titration combined with the traditional '3+3' design. After a single-patient observation at 0.5 mg, three patients will be enrolled per cohort at each subsequent dose level (1.0, 1.5, 2.0, 2.5, and 3.0 mg). Treatment will continue until disease progression, unacceptable toxicity, or withdrawal.
Related Therapeutic Areas
Sponsors
Leads: Hangzhou Weben Pharma Co., Ltd

This content was sourced from clinicaltrials.gov

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