Pancreatic Ductal Adenocarcinoma, Gastric Cancer, Gastroesophageal Junction Cancer, Biliary Tract Ca
Conditions
Interventions
Drug: AZD4360
Sponsors
Hibi Kazushige
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant must be 18 or more at the time of signing the ICF. 2. Eastern cooperative oncology group performance status of 0-1 with no deterioration over th e 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) wit h 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of participants with Dose-Limiting Toxicity (in dose escalation cohort), Adverse events (AEs) , Serious Adverse Events (SAEs) and AEs leading to discontinuation of AZD4360 | — |
Countries
Australia, Belgium, China, Germany, Italy, Japan, Netherlands, South Korea, Spain, Taiwan, UK, USA
Contacts
Public ContactKazushige Hibi
Astrazeneka K.K
Outcome results
None listed