[Translation] A multicenter, open-label, dose-escalation and dose-expansion phase I/II global study evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of IMD1828 in participants with advanced solid tumors.
Ia 期剂量递增阶段
主要目的:
1. 评估IMD1828在晚期实体瘤参与者中的安全性和耐受性。
2. 确定IMD1828的最大耐受剂量(MTD)和/或推荐扩展剂量(RDE)
次要目的:
1. 评估IMD1828的药代动力学特征。
2. 评估IMD1828的免疫原性。
3. 评估IMD1828的初步抗肿瘤活性。
探索性目的:
1. 探索莱古酶在肿瘤和肿瘤微环境中的生物标志物。
2. 探索CLDN 6在肿瘤中的生物标志物。
Ib期剂量扩展阶段和II期剂量优化阶段
主要目的:
1. 进一步评估IMD1828的安全性和耐受性。
2. 评估IMD1828在特定肿瘤类型中的初步抗肿瘤活性。
次要目的:
1. 确认IMD1828的PK特征。
2. 评估IMD1828的免疫原性。
3. 进一步评估IMD1828的疗效。
探索性目的:探索莱古酶和/或CLDN 6生物标志物表达与临床有效性之间的关联。
[Translation] Phase Ia Dose Escalation Phase
Primary Objectives:
1. To evaluate the safety and tolerability of IMD1828 in participants with advanced solid tumors.
2. To determine the maximum tolerated dose (MTD) and/or recommended dose extension (RDE) of IMD1828.
Secondary Objectives:
1. To evaluate the pharmacokinetic characteristics of IMD1828.
2. To evaluate the immunogenicity of IMD1828.
3. To evaluate the preliminary antitumor activity of IMD1828.
Exploratory Objectives:
1. To explore the biomarkers of leigluzi in tumors and the tumor microenvironment.
2. To explore the biomarkers of CLDN 6 in tumors.
Phase Ib Dose Extension Phase and Phase II Dose Optimization Phase
Primary Objectives:
1. To further evaluate the safety and tolerability of IMD1828.
2. To evaluate the preliminary antitumor activity of IMD1828 in specific tumor types.
Secondary objectives:
1. To confirm the PK characterization of IMD1828.
2. To assess the immunogenicity of IMD1828.
3. To further evaluate the efficacy of IMD1828.
Exploratory objective: To explore the association between the expression of leigluzi and/or CLDN 6 biomarkers and clinical efficacy.