[Translation] An open-label, multicenter, dose-escalation Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of HCB301 injection in patients with advanced solid tumors and relapsed or refractory classical Hodgkin's lymphoma
本试验目的为针对 18 岁及以上晚期实体肿瘤及复发难治经典霍奇金淋巴瘤受试者,探讨HCB301 IV输注的安全性、耐受性、药物动力学及抗肿瘤活性。 主要目的:评估 HCB301 的安全性及耐受性 ;确认MTD 和RDE(扩展期推荐剂量)。
次要目的:探讨不同剂量等级,受试者接受 HCB301 单次及重复给药的PK特性;评估 HCB301 重复剂量对受试者的初步抗肿瘤活性及其反应持续时间。
药效学目的:验证 HCB301 疗效及安全性变项的使用剂量与反应关系 ;验证HCB301 反应/临床结果的潜在预测性生物标记 。
[Translation] The purpose of this trial is to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of HCB301 IV infusion in subjects aged 18 years and above with advanced solid tumors and relapsed and refractory classical Hodgkin's lymphoma. Primary objective: To evaluate the safety and tolerability of HCB301; to confirm the MTD and RDE (recommended dose for extension phase).
Secondary objective: To explore the PK characteristics of subjects receiving single and repeated administration of HCB301 at different dose levels; to evaluate the initial anti-tumor activity of repeated doses of HCB301 on subjects and the duration of response.
Pharmacodynamic objective: To verify the dose-response relationship of HCB301 efficacy and safety variables; to verify potential predictive biomarkers of HCB301 response/clinical outcomes.