A Phase 1b / 2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of Oleclumab (MEDI9447) With or Without Durvalumab in Combination With Chemotherapy in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma
18 - 101 Years, Male and Female
The objective of this study is to evaluate the safety, tolerability, and antitumor activity of oleclumab (MEDI9447) in combination with or without durvalumab plus chemotherapy in subjects with metastatic pancreatic cancer.
This is a Phase 1b/2, multicenter, open-label, dose-escalation, and dose-expansion study to
assess the safety, preliminary antitumor activity, immunogenicity, and PK of oleclumab with
or without durvalumab in combination with chemotherapy administered in subjects with
metastatic PDAC. Subjects with previously untreated metastatic PDAC (1L metastatic PDAC) with
be enrolled in Cohort A. Subjects with metastatic PDAC previously treated with
gemcitabine-based chemotherapy (without exposure to 5-FU, capecitabine, or oxaliplatin, 2L
metastatic PDAC) will be enrolled in Cohort B. The study consists of 2 parts, dose escalation
(part 1) and dose expansion (Part 2).