Phase II Study to Assess Safety and Effectiveness of AZD0901 Alone and Combined With Chemotherapy in Advanced Solid Tumors Expressing Claudin18.2

What this Trial Is About

Researchers are evaluating AZD0901, an antibody-drug conjugate, in people with advanced solid tumors that express Claudin18.2, including gastric, gastroesophageal junction, pancreatic, and biliary tract cancers. This Phase II open-label study aims to assess the safety, tolerability, effectiveness, how the drug is processed in the body, and immune response to AZD0901, both alone and combined with chemotherapy agents. The study includes multiple substudies focusing on different cancer types and treatment combinations. Participants receive AZD0901 through intravenous infusion. Substudy 1 tests AZD0901 alone in patients with advanced gastric or gastroesophageal junction cancer, randomizing them into two groups. Substudy 2 has a safety run-in and dose expansion phase evaluating AZD0901 combined with chemotherapy in pancreatic cancer patients. Substudy 3 assesses AZD0901 monotherapy in advanced biliary tract cancer. Treatment schedules vary by substudy and include combinations with chemotherapy drugs like 5-Fluorouracil, Leucovorin, Irinotecan, and Gemcitabine. During the study, participants undergo evaluations including adverse event monitoring, lab tests, vital signs, heart monitoring, and physical exams. Tumor response is assessed over approximately two years, alongside survival and progression outcomes. Researchers also monitor drug levels and immune responses up to 90 days after treatment stops. The study involves regular visits for treatment and follow-up to evaluate safety and anti-tumor activity, with participation lasting until disease progression or study completion.

AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2