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A Study to Evaluate ATP150/ATP152/ATP162, VSV-GP154 and Ezabenlimab in Patients With Pancreatic Ductal Adenocarcinoma
Trial Status: active
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.
Inclusion Criteria
Key inclusion criteria
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC)
- ECOG performance status of 0 or 1.
- Patients with advanced or metastatic disease who completed at least 16 weeks of
standard of care systemic chem-/chemoradiotherapy and achieved a partial response or
stable disease.
- Patients who underwent confirmed R0 or R1 resection and completed at least 3 months
of combined peri-adjuvant multiagent chemotherapy.
- No evidence of disease progression or recurrence.
- Start of study treatment within 12 weeks from the last curative treatment (resected
PDAC).
- Patient must have completed 8-12 cycles of FOLFIRINOX or mFOLFIRINOX either as
adjuvant, neoadjuvant, or perioperative (Part C)
- Life expectancy at least 12 months (resected PDAC), or at least 6 months
(advanced/metastatic PDAC).
- Archival tumor tissue availability for central KRAS analysis and research.
Key exclusion criteria
- Not yet recovered from surgery (resected PDAC).
- Gastro-intestinal bowel obstruction.
- Other malignancy within the last 3 years.
- Prior chemotherapy or targeted small molecule therapy within 14 (locally
advanced/metastatic PDAC) or 28 (resected PDAC) days from initiation of study
treatment.
- Prior radiotherapy within 14 days (advanced/metastatic PDAC). No prior radiotherapy.
in resected PDAC
- Prior use of immunotherapeutic agents, including but not limited to checkpoint
inhibitors or VSV-based agents.
- Diagnosis of immunodeficiency, and/or history of allogeneic organ transplant
- Chronic systemic treatment with steroids or other immunosuppressive medications.
- Active autoimmune disease requiring systemic treatment within the last 2 years.
- Chronic or concurrent active infectious disease requiring systemic antibodies,
antifungal, or antiviral treatment
- Major (according to the Investigator's judgment) surgery within 12 weeks from
initiation of study treatment
- Use of Tamoxifen within 1 month prior to start of study treatment
Additional locations may be listed on ClinicalTrials.gov for NCT05846516.
