Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Switzerland / NCT05846516
Active, not recruiting Phase 1

A Study to Evaluate ATP150/ATP152/ATP162, VSV-GP154 and Ezabenlimab in Patients With Pancreatic Ductal Adenocarcinoma

NCT05846516 · tracked via the Priya Life Science Switzerland tracker
Sponsor
Boehringer Ingelheim
Phase
Phase 1
Started
2023-05-11
Last updated
2026-08-14

Condition(s) studied

Pancreatic Ductal Adenocarcinoma

Investigational drug(s) / intervention(s)

VSV-GP154ATP150ATP152Ezabenlimab →ATP162

VSV-GP154: VSV-GP154

ATP150: ATP150

ATP152: ATP152

Ezabenlimab: Ezabenlimab

ATP162: ATP162

Study summary

This study has stopped recruitment.

Adults with advanced pancreatic cancer participate in this study. The study tests a type of immunotherapy. It is a protein treatment (ATP150/ATP152/ATP162) combined with a virus (VSV-GP154) that may kill cancer cells and help the immune system fight cancer. The immunotherapy is combined with a study medicine called ezabenlimab. Ezabenlimab is an antibody that may also help the immune system fight cancer.

The purpose is to find the highest dose of the immunotherapy that people with pancreatic cancer can tolerate when taken alone or together with ezabenlimab (Part A and B). To find out, researchers look at the number of participants with certain severe health problems. The original purpose of the subsequent Part C was to check whether the immunotherapy combined with ezabenlimab may increase survival and prevent the cancer getting worse over time. The recruitment into Part C was not continued and stopped.

Participants can stay in the study as long as they tolerate the treatment or up to 1 year. During that time, they regularly visit the site. At all visits, the doctors closely check the health of the participants and note any severe health problems.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
University of Southern California Los Angeles California
University of California Los Angeles Santa Monica California
University of Colorado Cancer Center Aurora Colorado
University of Florida Gainesville Florida
Orlando Health Cancer Institute Orlando Florida
Karmanos Cancer Institute Detroit Michigan
Perlmutter Cancer Center at NYU Langone Hospital - Long Island New York New York
University Hospitals Cleveland Medical Center Cleveland Ohio
The University of Texas MD Anderson Cancer Center Houston Texas
START South Texas Accelerated Research Therapeutics, LLC San Antonio Texas
Virginia Cancer Specialists, PC Fairfax Virginia
Virginia Mason Medical Center Seattle Washington
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Hospital Universitari Vall d'Hebron Barcelona Spain
Hospital Universitario Reina Sofía Córdoba Spain
Hospital General Universitario Gregorio Marañón Madrid Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Clara Campal Comprehesive Cancer Center Madrid Spain
University Hospital Bern Bern Switzerland
Hopitaux Universitaires de Geneve (HUG) Geneva Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne Switzerland

More Boehringer Ingelheim trials in Switzerland

DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemoimmunotherapy Recruiting
EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease Recruiting
A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast Active, not recruiting
A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis Recruiting
PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease Recruiting

Other trials for the same condition

A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A) Recruiting
A Study Comparing Navlimetostat (BMS-986504) in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine in Participants With Untreated Metastatic Pancreatic Ductal Adenocarcinoma With Homozygous MTAP Deletion (MountainTAP-30) Active, not recruiting
Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05846516 on ClinicalTrials.gov ↗ ← All trials in Switzerland