A Phase I/II study of AZD4360 in adult participants with advanced solid tumors
Research type
Research Study
Full title
A Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD4360 in Adult Participants with Advanced Solid Tumours
IRAS ID
1012446
Contact name
Juliet Wou
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
This study evaluates AZD4360, a novel Antibody-Drug Conjugate (ADC) that specifically targets Claudin 18.2 (CLDN18.2), a protein found on certain cancer cells. There is an urgent need for new treatments for cancers with limited options, such as Pancreatic Ductal Adenocarcinoma (PDAC), Gastric/Gastroesophageal Junction Cancer (G/GEJC), and Biliary Tract Cancer (BTC). The goal is to provide new therapeutic possibilities for these patients.
This is a Phase I/II, open-label, multicenter study with dose escalation and expansion phases. The primary objectives are to assess the safety and tolerability of AZD4360 in adults with advanced solid tumors and to determine the Maximum Tolerated Dose (MTD) and/or Recommended Phase II Dose (RP2D). Secondary objectives include evaluating preliminary efficacy (Objective Response Rate, Disease Control Rate, Progression-Free Survival, Overall Survival), pharmacokinetics, pharmacodynamics, and anti-drug antibodies, as well as exploring how genetic and other multi-omics variations may affect outcomes.
Eligible participants are adults (≥18 years) with histologically confirmed advanced or metastatic PDAC, G/GEJC, or BTC, showing positive CLDN18.2 expression (≥25%). Participants must have adequate organ function and provide tumor tissue and blood samples. Study phases include pre-screening, screening, treatment, and follow-up, with regular safety monitoring, laboratory tests, imaging, and sample collection for biomarker analysis. Some cohorts may require tumor biopsies before and during treatment.
AZD4360 is administered intravenously every three weeks. The study is sponsored by AstraZeneca and conducted across multiple countries and regions, with close monitoring and management of potential toxicities according to Toxicity Management Guidelines (TMGs).REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
25/NE/0132
Date of REC Opinion
4 Sep 2025
REC opinion
Favourable Opinion