Study for AZD4360 in Participants With Advanced Solid Tumours
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.
| Condition(s) | Gastric Cancer, Gastroesophageal Junction Cancer, Biliary Tract Cancer, Pancreatic Ductal Adenocarcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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/me |
| Ages | 18 Years to 130 Years |
| Sex | All |
| Lead sponsor | AstraZeneca |
| Locations | Santa Monica, California, United States; Providence, Rhode Island, United States; Houston, Texas, United States; Beijing, China; Chengdu, China; Shanghai, China (+12 more sites) |
| Start date | 2025-04-29 |
| NCT ID | NCT06921928 |
| Official listing | https://clinicaltrials.gov/study/NCT06921928 |