Pancreatic Ductal AdenocarcinomaPhase 1NCT05846516
A Study to Evaluate ATP150/ATP152/ATP162, VSV-GP154 and Ezabenlimab in Patients With Pancreatic Ductal Adenocarcinoma
A Phase 1 study testing VSV-GP154, ATP150 and ATP152 in people with Pancreatic Ductal Adenocarcinoma, run by Boehringer Ingelheim at 21 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- VSV-GP154, ATP150 and ATP152
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 21 sitesin 4 countries
- Study dates
- 11 May 2023to 8 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
21 sites in 4 countries.
21 sites in 4 countries
United States12 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Karmanos Cancer Institute
Detroit, Michigan, 48201
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
University of Florida
Gainesville, Florida, 32610
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Southern California
Los Angeles, California, 90033
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
New York, New York, 10016
Orlando Health Cancer Institute
Orlando, Florida, 32806
START South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229
University of California Los Angeles
Santa Monica, California, 90404
Virginia Mason Medical Center
Seattle, Washington, 98101
Spain5 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitario Reina Sofía
Córdoba, 14004
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Clara Campal Comprehesive Cancer Center
Madrid, 28050
Switzerland3 sites
University Hospital Bern
Bern, 3010
Hopitaux Universitaires de Geneve (HUG)
Geneva, CH-1205
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, 1011
About this study
Official title: 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.
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.
Read more
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.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- VSV-GP154, ATP150, ATP152, Ezabenlimab, ATP162
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSV-GP154Drug
VSV-GP154
ATP150Drug
ATP150
ATP152Drug
ATP152
EzabenlimabDrug
Ezabenlimab
ATP162Drug
ATP162
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Not described Receives: Drug: VSV-GP154; Drug: ATP150; Drug: ATP152 |
| Cohort B | Experimental | Not described Receives: Drug: VSV-GP154; Drug: ATP150; Drug: ATP152; Drug: Ezabenlimab |
| Cohort C Treatment | Experimental | Not described Receives: Drug: VSV-GP154; Drug: Ezabenlimab; Drug: ATP162 |
| Cohort C Observational | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose-limiting toxicity (DLT)
Part A and B
Measured: Over at least 35 days
Disease-free survival (DFS), defined as the time from randomization until confirmed relapse or death from any cause, whichever occurs earlier.
Part C
Measured: 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
Measured: Throughout the study, up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start11 May 2023
- Primary completion8 Mar 2027 (estimated)
- Study completion8 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846516
- Sponsor's protocol ID
- 1515-0001
- Status last verified
- Aug 2026
- First submitted
- 18 Apr 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05846516
- Acronym / sponsor ID
- 1515-0001
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 11 May 2023 (actual)
- Primary completion
- 8 Mar 2027 (estimated)
- Study completion
- 8 Mar 2027 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: VSV-GP154, Drug: ATP150, Drug: ATP152 |
| Cohort B | Experimental | Drug: VSV-GP154, Drug: ATP150, Drug: ATP152, Drug: Ezabenlimab |
| Cohort C Treatment | Experimental | Drug: VSV-GP154, Drug: Ezabenlimab, Drug: ATP162 |
| Cohort C Observational | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VSV-GP154VSV-GP154 | Drug | Cohort A, Cohort B, Cohort C Treatment |
| ATP150ATP150 | Drug | Cohort A, Cohort B |
| ATP152ATP152 | Drug | Cohort A, Cohort B |
| EzabenlimabEzabenlimab | Drug | Cohort B, Cohort C Treatment |
| ATP162ATP162 | Drug | Cohort C Treatment |
Primary outcome
Occurrence of dose-limiting toxicity (DLT)
Time frame: Over at least 35 days
Part A and B
Disease-free survival (DFS), defined as the time from randomization until confirmed relapse or death from any cause, whichever occurs earlier.
Time frame: Through study completion, an average of 24 months.
Part C
1 secondary outcome
Occurrence of dose-limiting toxicity (DLT) during the on-treatment period
Time frame: Throughout the study, up to 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VSV-GP154, ATP150 and ATP152 in people with Pancreatic Ductal Adenocarcinoma, run by Boehringer Ingelheim at 21 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Spain, Switzerland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of dose-limiting toxicity (DLT) (time frame: Over at least 35 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.