NCT06820268

A Study of XS-04 in Patients with Relapsed or Refractory Hematologic Malignancies

A Phase I Trial to Evaluate the Tolerability, Pharmacokinetics and Preliminary Efficacy of XS-04 in Patients with Hematologic Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: NovaOnco Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the safety, tolerability, pharmacokinetics, and preliminary efficacy of XS-04 in patients with relapsed or refractory hematologic malignancies

Detailed description

Main Objective: To evaluate the safety and tolerability of XS-04 tablets in patients with relapsed or refractory hematologic malignancies. To determine the maximal tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) of XS-04 tablets. Secondary Objective: To determine the pharmacokinetic (PK) characteristics of XS-04 tablets after single and multiple oral administrations. To preliminarily evaluate the efficacy of XS-04 tablets in patients with relapsed or refractory hematologic malignancies. Exploratory Objective: To preliminarily assess the metabolic transformation characteristics after oral administration of XS-04 tablets. To evaluate the population PK and exposure-effect (E-R) relationship. To explore the association between relevant biomarkers and drug efficacy; to explore the correlation between PD biomarkers and PK. To assess the impact of food on the PK characteristics of orally administered XS-04 tablets in patients.

Conditions

• B-cell Lymphoma
• Acute Myeloid Leukemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	XS-04 tablet	Each treatment cycle is 28 days, with continuous oral administration, twice daily.

Timeline

• Start date: 2025-01-14
• Primary completion: 2027-11-01
• Completion: 2028-03-15
• First posted: 2025-02-11
• Last updated: 2025-03-04

Locations

4 sites across 1 country: China