To Evaluate a Phase I/II Clinical Study of XNW5004 Tablets in Patients With Relapsed/Refractory Advanced Tumors
NCT Number: NCT06558513
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Advanced Tumor|Lymphoma
Interventions: DRUG: XNW5004 tablets
Sponsor: Evopoint Biosciences Inc.
Collaborators: Shanghai Dingyue Biotechnology Co., LTD|Beijing Jiyingjia Medical Laboratory Co.,Ltd.|Shanghai Jinghan Biological Technology Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 176
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-07-05
Completion Date: 2024-12-31
Locations: Hematology Hospital, Chinese Academy of Medical Sciences, Tianjin, China

Summary:
Patients with advanced tumors diagnosed histologically or cytologically at the study center who were refractory to standard therapy or had relapsed received XNW5004 tablets

Primary Outcome Measures: Incidence and severity of treatment-emergent adverse events (AEs)[Safety and Tolerability], The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of XNW5004 will be assessed., through study completion, an average of about 10 months|Recommended phase 2 dose (RP2D), Recommended phase 2 dose (RP2D) will be established according to the incidence of dose-limiting toxicities (DLTs) of escalated doses of XNW5004., 28 days since the date of first dose in phase 1
Secondary Outcome Measures: Time to peak (Tmax), Pharmacokinetics profile of a single dose and continuous medication of XNW5004 and its metabolite (plasma): Time to peak (Tmax) of plasma concentration, 28 days since the date of first dose|Maximum plasma concentration (Cmax), Pharmacokinetics profile of a single dose and continuous medication of XNW5004 and its metabolite (plasma): Maximum plasma concentration (Cmax), 28 days since the date of first dose|Halflife (T1/2), Pharmacokinetics profile of a single dose and continuous medication of XNW5004 and its metabolite (plasma): Halflife (T1/2), 28 days since the date of first dose|Objective response rate (ORR), Assess the response rate of subjects to the treatment of XNW5004, every 8 weeks through study completion, an average of about 10 months|Progression-free survival (PFS), Assess the progression-free survival of the subjects after the treatment of XNW5004, every 8 weeks through study completion, an average of about 10 months|Duration of Response (DoR), Assess the duration of Response of the subjects after the treatment of XNW5004, every 8 weeks through study completion, an average of about 10 months|Complete response rate (CRR), Assess the Complete response rate of the subjects after the treatment of XNW5004, every 8 weeks through study completion, an average of about 10 months|Partial response rate (PRR), Assess the partial response rate of the subjects after the treatment of XNW5004, every 8 weeks through study completion, an average of about 10 months|Disease control rate (DCR), Assess the disease control rate of the subjects after the treatment of XNW5004, every 8 weeks through study completion, an average of about 10 months|The correlation between potential biomarkers (including but not limited to EZH2 mutations, etc.) and therapeutic efficacy, Assess the correlation between potential biomarkers (including but not limited to EZH2 mutations, etc.) and therapeutic efficacy of the subjects after the treatment of XNW5004, every 8 weeks through study completion, an average of about 10 months|H3K27me3 (H3 histone 27th lysine trimethylation)/H3 histone relative baseline change level, Assess the H3K27me3 (H3 histone 27th lysine trimethylation)/H3 histone relative baseline change level of the subjects after the treatment of XNW5004, 28 days since the date of first dose