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Active, not recruitingNCT05846516Updated Aug 14, 2026

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

A Phase 1 interventional study of VSV-GP154 and ATP150 in Pancreatic Ductal Adenocarcinoma, sponsored by Boehringer Ingelheim. Active, not recruiting at 21 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
59
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Pancreatic Ductal Adenocarcinoma
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    Cohort A

    Drug: VSV-GP154 · Drug: ATP150 · Drug: ATP152

  • Experimental
    Cohort B

    Drug: VSV-GP154 · Drug: ATP150 · Drug: ATP152 · Drug: Ezabenlimab

  • Experimental
    Cohort C Treatment

    Drug: VSV-GP154 · Drug: Ezabenlimab · Drug: ATP162

  • No intervention
    Cohort C Observational

Interventions

  • DrugVSV-GP154

    VSV-GP154

  • DrugATP150

    ATP150

  • DrugATP152

    ATP152

  • DrugEzabenlimab

    Ezabenlimab

  • DrugATP162

    ATP162

06

What researchers measure

Primary outcomes

  1. Occurrence of dose-limiting toxicity (DLT)

    Part A and B

    Time frame: Over at least 35 days

  2. Disease-free survival (DFS), defined as the time from randomization until confirmed relapse or death from any cause, whichever occurs earlier.

    Part C

    Time frame: Through study completion, an average of 24 months.

Secondary outcomes

  1. Occurrence of dose-limiting toxicity (DLT) during the on-treatment period

    Part B and C

    Time frame: Throughout the study, up to 12 months.

07

Study locations

21 sites
  • University of Southern California
    Los Angeles, California 90033, United States
  • University of California Los Angeles
    Santa Monica, California 90404, United States
  • University of Colorado Cancer Center
    Aurora, Colorado 80045, United States
  • University of Florida
    Gainesville, Florida 32610, United States
  • Orlando Health Cancer Institute
    Orlando, Florida 32806, United States
  • Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island
    New York, New York 10016, United States
  • University Hospitals Cleveland Medical Center
    Cleveland, Ohio 44106, United States
  • The University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • START South Texas Accelerated Research Therapeutics, LLC
    San Antonio, Texas 78229, United States
  • Virginia Cancer Specialists, PC
    Fairfax, Virginia 22031, United States
  • Virginia Mason Medical Center
    Seattle, Washington 98101, United States
  • Asklepios Kliniken Hamburg GmbH
    Hamburg, 22763, Germany
  • Hospital Universitari Vall d'Hebron
    Barcelona, 08035, Spain
  • Hospital Universitario Reina Sofía
    Córdoba, 14004, Spain
  • Hospital General Universitario Gregorio Marañón
    Madrid, 28007, Spain
  • Hospital Universitario Fundacion Jimenez Diaz
    Madrid, 28040, Spain
  • Clara Campal Comprehesive Cancer Center
    Madrid, 28050, Spain
  • University Hospital Bern
    Bern, 3010, Switzerland
  • Hopitaux Universitaires de Geneve (HUG)
    Geneva, CH-1205, Switzerland
  • Centre Hospitalier Universitaire Vaudois (CHUV)
    Lausanne, 1011, Switzerland
08

References and documents

Related links

Individual participant data

Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05846516
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
May 6, 2023
Start date
May 11, 2023
Primary completion
Mar 8, 2027 (estimated)
Completion
Mar 8, 2027 (estimated)
Last update
Aug 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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