The purpose of this study is to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 in adult participants with locally advanced or metastatic solid tumours selected for expression of CLDN18.2.
Participant must be ≥ 18 at the time of signing the ICF.
Eastern cooperative oncology group performance status of 0-1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
Minimum life expectancy of 12 weeks in the opinion of the Investigator.
Human Epidermal Growth Factor Receptor 2 (HER2) positive (3+ by IHC or 2+ by IHC and positive by in situ hybridisation) or indeterminate G/GEJC participants.
Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.
Participants with clinically significant ascites that require drainage.
Central nervous system (CNS) metastases or CNS pathology, as defined by protocol.
Sequential
AZD4360
DrugAntibody-Drug Conjugate targeting Claudin 18.2 (CLDN18.2)
Incidence of participants with Dose-Limiting Toxicity (in dose escalation cohort), Adverse events (AEs) , Serious Adverse Events (SAEs) and AEs leading to discontinuation of AZD4360
To investigate the safety and tolerability, and to determine the Maximum Tolerated Dose (MTD) and/or a Recommended Phase II Dose (R2PD) of AZD4360 in previously treated participants with advanced solid tumours, through the assessment of Dose Limiting Toxicities, Adverse Events and Severe Adverse Events.
Objective Response Rate (ORR)
The percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR). Radiological response evaluated according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Duration of Response (DoR)
The time from the date of first documented ORR until date of first documented Progression of Disease (PD) or death. Radiological response evaluated according to RECIST v1.1.
Disease Control Rate (DCR)
The percentage of participants who have a best objective response of confirmed CR or PR or who have Stable Disease for at least 11 weeks after start of treatment to allow for an early assessment within the assessment window. Radiological response evaluated according to RECIST v1.1.
Progression Free Survival (PFS)
The time from the start of treatment until the date of objective PD or death. Radiological response evaluated according to RECIST v1.1.
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