A Phase 1b Study to Evaluate the Safety Tolerability and Preliminary Efficacy of ATP150/ATP152 VSV-GP154 and Ezabenlimab (BI 754091) in Patients with KRAS G12D/G12V Mutated Pancreatic Ductal Adenocarcinoma

Brief description of study

This is an open-label, phase 1b study comprising two parts (safety and immunogenicity part and randomized efficacy part) to evaluate the safety, tolerability, preliminary efficacy, and immunogenicity of a heterologous prime-boost vaccine (protein and viral vector) strategy, in which approximately 90 patients with resected KRAS G12D/G12V mutated pancreatic cancer and colorectal cancer after (neo-) adjuvant chemotherapy or chemoradiotherapy will be enrolled in the following treatment parts of the study: Part 1 (Safety and Immunogenicity Part) – PDAC and CRC patients Part 2 (Efficacy Part) – PDAC patients only


Clinical Study Identifier: s22-00392
ClinicalTrials.gov Identifier: NCT05846516
Principal Investigator: Paul E. Oberstein.
Other Investigators: Daniel J Becker, Kristen Spencer, Keriann M Scavone, Nina Beri, Jennifer Chuy, Rafael Winograd, Shun Yu.


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