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ATP150/ATP152, VSV-GP154 and Ezabenlimab (BI 754091) in Adenocarcinoma

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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

  • Sex: Any
  • Age: Adult (18 - 64), Older Adult (65+)
  • Accepting Healthy People: No
  • Type: Interventional / Therapeutic
  • Trial Phase: Phase I
  • Conditions Being Studied: Cancer - Pancreas

Study Purpose

This study is open to adult with Pancreatic Ductal Adenocarcinoma (PDAC). The purpose of this study is to find out whether a medicine called KISIMA-02 can help people with PDAC when taken alone or in combination with a medicine called Ezabenlimab. KISIMA-02 is given to humans for the first time, and it is a therapeutic protein vaccine (ATP150/ATP152/ATP162) and a viral vector VSV-GP154. Ezabenlimab is a type of antibody that may help the immune system fight cancer (checkpoint inhibitor). There are 3 parts of the study: Part A, Part B and Part C. The main research objective in Part A and Part B is to find the highest dose of KISIMA-02 that people with PDAC can tolerate. The main research objective in Part C is to check whether KISIMA-02 has an impact in preventing a possible reappearance of the tumor. Participants visit the site study site regularly. The number of study visits vary based on the study Part. For one (1) of the visits, participants stay overnight for one (1) night at the study site. The doctors regularly check the participants' health and monitor the tumor. The doctors also take note of any health problems that could have been caused by the medicines.

Principal Investigator
Amit Mahipal MD
Department/Division
Cancer (Digestive System)
  • UH IRB: STUDY20230845
  • StudyID: AMAL1223
  • ClinicalTrials.gov: NCT05846516
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