This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.
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.
A Phase 1b Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Heterologous Prime Boost Vaccination (ATP150/ATP152/ATP162, VSV-GP154) and Ezabenlimab (BI 754091) in Patients With Pancreatic Ductal Adenocarcinoma.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Inclusion Criteria | Exclusion Criteria |
---|---|
|
|
Sponsor: Amal Therapeutics
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.