Study for AZD4360 in Participants With Advanced Solid Tumours

Launched by ASTRAZENECA · Apr 3, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called AZD4360 for adults with advanced solid tumors, specifically those diagnosed with gastric cancer, gastroesophageal junction cancer, biliary tract cancer, or pancreatic ductal adenocarcinoma. The main goal is to see how safe the treatment is, how well it works, and how the body processes it. To participate, individuals must be at least 18 years old and have already tried at least one other treatment for their cancer. They should also have a specific type of cancer that tests positive for a marker called CLDN18.2.

The trial is not yet recruiting participants, but those who qualify will be monitored closely throughout the study. This means that participants will have regular check-ups to ensure their safety and to see how well the treatment is working. It’s important to note that some people may not be eligible if they have certain health conditions or have received specific previous treatments. Overall, this trial aims to find a new option for patients facing difficult-to-treat cancers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participant must be ≥ 18 at the time of signing the ICF.
• • 2. 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.
• • 3. Minimum life expectancy of 12 weeks in the opinion of the Investigator.
• • 4 Adequate organ and marrow function, as defined by protocol.
• • 5. Contraceptive use by men or women should be consistent with local regulations, as defined by protocol.
• • 6. 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.
• • 7. Participants must have received at least one prior line of systemic therapy in the advanced/metastatic disease.
• • 8. At least one measurable lesion according to RECIST v1.1.
• Exclusion Criteria:
• • 1. 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.
• • 2. 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.
• • 3. Participants with clinically significant ascites that require drainage.
• • 4. Central nervous system (CNS) metastases or CNS pathology, as defined by protocol.
• • 5. With spinal cord compression or with high risk of paralysis.
• • 6. History of non-infectious interstitial lung disease/pneumonitis.
• • 7. Participant has cardiac abnormalities, as defined by protocol.
• • 8. History of another primary malignancy within 2 years prior to screening.
• • 9. Known serologic status reflecting active hepatitis B or hepatitis C.
• • 10. Known HIV infection that is not well controlled.
• • 11. Active tuberculosis infection.