This open-label Phase I/II study with dose-escalation and dose-expansion components evaluates AZD4360, a TOP1 inhibitor antibody–drug conjugate targeting Claudin-18.2 (CLDN18.2), in adult participants with advanced solid tumors. The objective is to assess safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of AZD4360. Eligible participants are adults with advanced malignant solid tumors. During the dose-escalation phase, participants receive increasing doses of the investigational drug, followed by a dose-expansion phase to further characterize the treatment. AZD4360 is designed to target tumor cells expressing the CLDN18.2 antigen. Secondary endpoints include pharmacokinetic and pharmacodynamic parameters as well as measures of antitumor efficacy.
This clinical study evaluates a new cancer treatment called AZD4360 in people with advanced solid tumors. AZD4360 is an antibody-drug conjugate designed to target tumor cells that express a protein called Claudin-18.2. The study aims to assess the safety of the treatment, how the drug behaves in the body, and whether it shows anti-tumor activity. Adults with advanced cancers may participate in the study. Participants receive the study drug at increasing dose levels to determine an appropriate dose. The treatment is then further evaluated in additional groups of participants.
