Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
NCT ID:
NCT06820268
Brief 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.
Study:
NCT06820268
Study Brief:
Protocol Section:
NCT06820268