An Open-label, Multi-center, Dose-escalation and Cohort Expansion Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Efficacy of ACR246 in Patients with Advanced Solid Tumors

The goal of the study is to evaluate the safety and tolerability of ACR246 in patients with advanced solid tumors, to determine the maximum tolerated dose (MTD) and Phase II recommended dose (RP2D) of ACR246.

Start Date29 Oct 2024

Sponsor / Collaborator

Hangzhou Adcoris Biopharmacy Co., LtdStartup

CTR20243274 / RecruitingPhase 1/2

一项在晚期实体瘤患者中评估ACR246安全性、耐受性、药代动力学特征与有效性的开放、多中心、剂量递增和队列扩展的I/Ⅱa期临床研究

[Translation] An open-label, multicenter, dose-escalation and cohort expansion phase I/IIa clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and efficacy of ACR246 in patients with advanced solid tumors

主要目的：评估ACR246在晚期实体瘤患者中的安全性和耐受性，确定ACR246的最大耐受剂量（MTD）和Ⅱ期推荐剂量（RP2D）。次要目的：评估ACR246、重组抗滋养层糖蛋白5T4（以下简称“5T4”）全人源化单克隆抗体（IP140B）、毒素分子D2102在晚期实体瘤患者体内的药代动力学（PK）特征；评估ACR246在晚期实体瘤患者中的免疫原性；评估ACR246在晚期实体瘤患者中的有效性；检测肿瘤组织5T4表达，探索其与有效性指标的相关性；探索ACR246在5T4表达的晚期实体瘤患者中暴露与效应之间的关系。

[Translation]

Primary objective: To evaluate the safety and tolerability of ACR246 in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and phase II recommended dose (RP2D) of ACR246. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of ACR246, recombinant anti-trophoblast glycoprotein 5T4 (hereinafter referred to as "5T4") fully humanized monoclonal antibody (IP140B), and toxin molecule D2102 in patients with advanced solid tumors; To evaluate the immunogenicity of ACR246 in patients with advanced solid tumors; To evaluate the effectiveness of ACR246 in patients with advanced solid tumors; To detect the expression of 5T4 in tumor tissues and explore its correlation with effectiveness indicators; To explore the relationship between exposure and effect of ACR246 in patients with advanced solid tumors expressing 5T4.

Start Date21 Oct 2024

Sponsor / Collaborator

Hangzhou Adcoris Biopharmacy Co., LtdStartup

100 Clinical Results associated with ACR246

100 Translational Medicine associated with ACR246

100 Patents (Medical) associated with ACR246

100 Deals associated with ACR246

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	CN	Hangzhou Adcoris Biopharmacy Co., LtdStartup	21 Oct 2024
Breast Cancer	Phase 2	CN	Hangzhou Adcoris Biopharmacy Co., LtdStartup	21 Oct 2024
Colorectal Cancer	Phase 2	CN	Hangzhou Adcoris Biopharmacy Co., LtdStartup	21 Oct 2024
Esophageal Carcinoma	Phase 2	CN	Hangzhou Adcoris Biopharmacy Co., LtdStartup	21 Oct 2024
Kidney Neoplasms	Phase 2	CN	Hangzhou Adcoris Biopharmacy Co., LtdStartup	21 Oct 2024
Non-Small Cell Lung Cancer	Phase 2	CN	Hangzhou Adcoris Biopharmacy Co., LtdStartup	21 Oct 2024
Ovarian Cancer	Phase 2	CN	Hangzhou Adcoris Biopharmacy Co., LtdStartup	21 Oct 2024
Pancreatic Cancer	Phase 2	CN	Hangzhou Adcoris Biopharmacy Co., LtdStartup	21 Oct 2024
Prostatic Cancer	Phase 2	CN	Hangzhou Adcoris Biopharmacy Co., LtdStartup	21 Oct 2024
Uterine Cervical Cancer	Phase 2	CN	Hangzhou Adcoris Biopharmacy Co., LtdStartup	21 Oct 2024

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