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一项开放性、剂量递增和剂量扩展评估EX101注射液治疗HER2阳性晚期实体瘤患者的I期临床研究
[Translation] An open-label, dose-escalation and dose-expansion phase I clinical study evaluating EX101 injection in patients with HER2-positive advanced solid tumors
剂量递增阶段:一、主要研究目的:1)评价EX101注射液在HER2阳性晚期实体瘤患者中的安全性、耐受性;2)探索剂量限制性毒性 (DLT),确定最大耐受剂量 (MTD)或II期临床试验推荐剂量(RP2D)。二、次要研究目的:1)评价EX101注射液在HER2阳性晚期实体瘤患者中的药代动力学特征;2)评价EX101注射液在HER2阳性晚期实体瘤患者中的初步有效性;3)评价EX101注射液在HER2阳性晚期实体瘤患者中的免疫原性。
剂量扩展阶段:一、主要研究目的:1)评价EX101注射液以推荐剂量在HER2阳性晚期乳腺癌和HER2阳性晚期胃癌/胃食管交界处腺癌患者中的安全性、耐受性;2)评价EX101注射液以推荐剂量在HER2阳性晚期乳腺癌和HER2阳性晚期胃癌/胃食管交界处腺癌患者中的有效性。二、次要研究目的:1)评价EX101注射液在HER2阳性晚期乳腺癌和HER2阳性晚期胃癌/胃食管交界处腺癌患者中的免疫原性。
[Translation] Dose escalation phase: 1. Main study objectives: 1) Evaluate the safety and tolerability of EX101 injection in patients with HER2-positive advanced solid tumors; 2) Explore dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) or the recommended dose (RP2D) for Phase II clinical trials. 2. Secondary study objectives: 1) Evaluate the pharmacokinetic characteristics of EX101 injection in patients with HER2-positive advanced solid tumors; 2) Evaluate the preliminary efficacy of EX101 injection in patients with HER2-positive advanced solid tumors; 3) Evaluate the immunogenicity of EX101 injection in patients with HER2-positive advanced solid tumors.
Dose expansion phase: 1. Main study objectives: 1) Evaluate the safety and tolerability of EX101 injection at the recommended dose in patients with HER2-positive advanced breast cancer and HER2-positive advanced gastric cancer/gastroesophageal junction adenocarcinoma; 2) Evaluate the efficacy of EX101 injection at the recommended dose in patients with HER2-positive advanced breast cancer and HER2-positive advanced gastric cancer/gastroesophageal junction adenocarcinoma. 2. Secondary study objectives: 1) To evaluate the immunogenicity of EX101 injection in patients with HER2-positive advanced breast cancer and HER2-positive advanced gastric cancer/gastroesophageal junction adenocarcinoma.
A Phase I/II Study Evaluating the Safety, Efficacy, and Pharmacokinetics of EX103 in Subjects with Relapsed/Refractory CD20-Positive Non-Hodgkin Lymphoma
This is a multicenter, single-arm, open, dose-escalation Phase I/II clinical trial, consisting of a dose-escalation phase (accelerated titration phase, 3+3 design) and a dose expansion phase.
一项评价EX103注射液在复发或难治CD20阳性非霍奇金淋巴瘤患者中的有效性、安全性、耐受性和药代动力学特征的I/II期临床研究
[Translation] A Phase I/II clinical study to evaluate the efficacy, safety, tolerability and pharmacokinetic characteristics of EX103 injection in patients with relapsed or refractory CD20-positive non-Hodgkin's lymphoma
主要目的:
1、评价EX103在复发或难治(R/R)CD20阳性非霍奇金淋巴瘤(CD20+ NHL)患者中的安全性和耐受性; 2、确定EX103在R/R CD20+ NHL患者中的剂量限制性毒性(DLT),确定最大耐受剂量(MTD)或最佳的生物剂量(OBD),为II期临床试验给药方案及剂量提供依据。
次要目的:
1、评价EX103在R/R CD20+ NHL患者中的药代动力学(PK)特征;
2、评价EX103在R/R CD20+ NHL患者中的药效学(PD)特征;
3、初步评价EX103在治疗R/R CD20+ NHL患者中的有效性;
4、初步评价EX103在R/R CD20+ NHL患者中的免疫原性。
[Translation] Main objectives:
1. Evaluate the safety and tolerability of EX103 in patients with relapsed or refractory (R/R) CD20-positive non-Hodgkin's lymphoma (CD20+ NHL); 2. Determine the dose-limiting toxicity (DLT) of EX103 in patients with R/R CD20+ NHL, determine the maximum tolerated dose (MTD) or optimal biological dose (OBD), and provide a basis for the dosing regimen and dose of Phase II clinical trials.
Secondary objectives:
1. Evaluate the pharmacokinetic (PK) characteristics of EX103 in patients with R/R CD20+ NHL;
2. Evaluate the pharmacodynamic (PD) characteristics of EX103 in patients with R/R CD20+ NHL;
3. Preliminarily evaluate the effectiveness of EX103 in the treatment of patients with R/R CD20+ NHL;
4. Preliminarily evaluate the immunogenicity of EX103 in patients with R/R CD20+ NHL.
100 Clinical Results associated with Excelmab, Inc.
0 Patents (Medical) associated with Excelmab, Inc.
100 Deals associated with Excelmab, Inc.
100 Translational Medicine associated with Excelmab, Inc.