A Phase I/IIa Multi-center, Open-label Master Protocol to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of AZD8205 in Participants with Advanced or Metastatic Solid Malignancies. - D6900C00001

Start Date29 Feb 2024

Sponsor / Collaborator

AstraZeneca AB

NL-OMON53228 / SuspendedNot Applicable

Clinical Performance Study Plan for use of B7-H4 (A57.1) Clinical Trial Assay for Patient Enrolment Into The Clinical study (D6900C00001), titled *A Phase I/IIa Multi-center, Open-label Master Protocol to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of AZD8205 in Participants with Advanced or Metastatic Solid Malignancies*. - AZD8205 in participants with metastatic solid malignancies

Start Date01 Jun 2023

Sponsor / Collaborator-

CTR20222618 / RecruitingPhase 1/2

一项在晚期或转移性实体恶性肿瘤受试者中评价AZD8205的安全性、耐受性、药代动力学、药效学和初步抗肿瘤活性的多中心、开放性、I/IIa期研究的主方案

[Translation] Master protocol for a multicenter, open-label, Phase I/IIa study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of AZD8205 in subjects with advanced or metastatic solid malignancies

主要目的是评估安全性和耐受性，并确定各子研究中AZD8205的最大耐受剂量和/或II期的推荐剂量；同时评估各子研究中AZD8205的初步抗肿瘤活性，描述各子研究中AZD8205的PK特征，确定各子研究中AZD8205的免疫原性。

[Translation]

The primary objectives are to evaluate safety and tolerability, and to determine the maximum tolerated dose of AZD8205 in each sub-study and/or the recommended dose for Phase II; to evaluate the preliminary anti-tumor activity of AZD8205 in each sub-study, to describe the PK characteristics of AZD8205 in each sub-study, and to determine the immunogenicity of AZD8205 in each sub-study.

Start Date26 Dec 2022

Sponsor / Collaborator

AstraZeneca Global R&D (China) Co., Ltd.

[+2]

100 Clinical Results associated with TOP1 x B7-H4

100 Translational Medicine associated with TOP1 x B7-H4

0 Patents (Medical) associated with TOP1 x B7-H4

Literatures (Medical) associated with TOP1 x B7-H4

14 Mar 2023·Clinical Cancer Research

New Life of Topoisomerase I Inhibitors as Antibody–Drug Conjugate Warheads

Communications

Author: Pommier, Yves ; Thomas, Anish

SummaryAntibody–drug conjugates (ADC) allow the delivery of cytotoxic chemotherapeutic agents to tumors. Two ADC delivering topoisomerase I (TOP1) poisons (Enhertu and Trodelvy) have recently been FDA-approved for Her2- and Trop2-expressing solid tumors. In a recent study, a TOP1-anti B7-H4 ADC was described and shown to be synergistic with a novel PARP1-selective inhibitor.See related article by Kinneer et al., p. 1086

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