NCT06921928 Study for AZD4360 in Participants With Advanced Solid Tumours
| NCT ID | NCT06921928 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | AstraZeneca |
| Condition | Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 117 participants |
| Start Date | 2025-04-29 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 117 participants in total. It began in 2025-04-29 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06921928 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 130 Years, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06921928 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06921928 currently recruiting?
Yes, NCT06921928 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT06921928 trial being conducted?
This trial is being conducted at Santa Monica, United States, Providence, United States, Houston, United States, Beijing, China and 11 additional locations.
Who is sponsoring the NCT06921928 clinical trial?
NCT06921928 is sponsored by AstraZeneca. The trial plans to enroll 117 participants.
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