[Translation] An open-label, multicenter, dose-escalation Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of HCB101 injection in advanced solid tumors and relapsed and refractory non-Hodgkin's lymphoma
主要目的:评估HCB101的安全性及耐受性,确认MTD
次要目的:探讨不同剂量等级下,受试者接受HCB101单一剂量及重复剂量的 PK 特性;评估HCB101重复剂量对受试者的初步抗肿瘤活性及其反应持续时间;
探索性目的:探索HCB101疗效及安全性变项的使用剂量与反应关系;探索HCB101反应/临床结果的潜在预测性生物标记;探索HCB101药效学反应。
[Translation] Primary purpose: To evaluate the safety and tolerability of HCB101 and confirm the MTD
Secondary purpose: To explore the PK characteristics of single and repeated doses of HCB101 in subjects at different dose levels; To evaluate the initial anti-tumor activity of repeated doses of HCB101 in subjects and the duration of response;
Exploratory purpose: To explore the dose-response relationship of HCB101 efficacy and safety variables; To explore potential predictive biomarkers of HCB101 response/clinical outcomes; To explore the pharmacodynamic response of HCB101.