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Evaluating AZD4360 for advanced solid tumors

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

Phase1; Phase2 Interventional AstraZeneca · NCT06921928

This study is testing a new treatment called AZD4360 to see if it can help adults with advanced solid tumors, like certain types of cancer in the stomach or pancreas, who have already tried other therapies.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment117 (estimated)
Ages18 Years to 130 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Locations18 sites (Santa Monica, California and 17 other locations)
Trial IDNCT06921928 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 in adult patients with advanced solid tumors that express CLDN18.2. Participants must have a confirmed diagnosis of gastric cancer, gastroesophageal junction cancer, biliary tract cancer, or pancreatic ductal adenocarcinoma and have received at least one prior line of systemic therapy. The study will involve monitoring participants for various health metrics and responses to the treatment over the course of the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced or metastatic solid tumors that express CLDN18.2 and have previously undergone systemic therapy.

Not a fit: Patients with HER2 positive tumors or those who do not express CLDN18.2 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors expressing CLDN18.2.

How similar studies have performed: Other studies targeting CLDN18.2 have shown promise, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Santa Monica, California and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Gastric CancerGastroesophageal Junction CancerBiliary Tract CancerPancreatic Ductal AdenocarcinomaAdvanced Solid TumoursAZD4360Claudin 18.2
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.