AZD4360 for Gastric cancer | Gastroesophageal junction cancer | Biliary tract cancer | Pancreatic ductal adenocarcinoma

Inclusion criteria

• {"criterion_text":"- Participant must be ≥ 18 at the time of signing the ICF.\n- 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.\n- Minimum life expectancy of 12 weeks in the opinion of the Investigator.\n- Adequate organ and marrow function, as defined by protocol.\n- Contraceptive use by men or women should be consistent with local regulations, as defined by protocol.\n- Histologically confirmed advanced or metastatic Pancreatic ductal adenocarcinoma (PDAC), Gastric or Gastroesophageal junction cancer (G/GEJC), and Biliary tract cancer (BTC) with documented positive CLDN18.2 expression.\n- Participants must have received at least one prior line of systemic therapy in the advanced/metastatic disease.\n- At least one measurable lesion according to RECISTv1.1."}

Exclusion criteria

• {"criterion_text":"- 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.\n- Known HIV infection that is not well controlled.\n- Active tuberculosis infection.\n- 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.\n- Participants with clinically significant ascites that require drainage.\n- Central nervous system (CNS) metastases or CNS pathology, as defined by protocol.\n- With spinal cord compression or with high risk of paralysis.\n- History of non-infectious interstitial lung disease/pneumonitis.\n- Participant has cardiac abnormalities, as defined by protocol.\n- History of another primary malignancy within 2 years prior to screening.\n- Known serologic status reflecting active hepatitis B or hepatitis C."}

Primary endpoints

• {"endpoint_text":"- Frequency of DLTs (dose escalation cohort)\n- Incidence of AEs, SAEs, and AEs leading to discontinuation of AZD4360\n- Assess clinically significant changes in vital signs, laboratory parameters, and ECG results","definition_or_measurement_approach":"Frequency of dose-limiting toxicities in the dose-escalation cohort; incidence counts and rates for adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation; clinical assessment of changes in vital signs, laboratory parameters and ECG results as defined by protocol."}

Secondary endpoints

• {"endpoint_text":"- Radiological response evaluated according to RECISTv1.1: Overall Response Rate, Duration of Response,Disease Control Rate, and Progression-free Survival\n- Overall Survival\n- Pharmamokinetics end points: Plasma concentration of AZD4360 total antibody and other analytes\n- Plasma PK parameters of AZD4360, total antibody andother analytes including but not limited to AUC, Cmax, tmax, clearance, and half-life, as data allow\n- Immunogenecitiy end point: Number and percentage of participants who develop ADA against AZD4360","definition_or_measurement_approach":"Radiological response per RECIST v1.1 (ORR, DoR, DCR, PFS); overall survival measured from baseline to death; PK measured as plasma concentrations and derived PK parameters (AUC, Cmax, tmax, clearance, half-life); immunogenicity measured as number and percent of participants with anti-drug antibodies (ADA)."}

Germany

Earliest CTIS Part Ii Submission Date

22-08-2025

Latest Decision Or Authorization Date

06-01-2026

Processing Time Days

137

Number Of Sites

3

Number Of Participants

17

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden