A Study To Evaluate ATP150/ATP152, VSV-GP154 And Ezabenlimab In Patients With KRAS G12D/G12V Mutated PDAC (KISIMA-02)

Study Overview

A Study to Evaluate ATP150/ATP152, VSV-GP154 and Ezabenlimab in Patients With KRAS G12D/G12V Mutated PDAC (KISIMA-02)

The goal of this clinical trial is to test an experimental treatment (immunotherapy) in pancreatic cancer patients. The main research objectives are: * to evaluate if the KISIMA-02 treatment is safe and well-tolerated (first part) * to evaluate if the KISIMA-02 treatment has an impact on the time to observe a possible reappearance of the tumor (second part) Participants will receive: i) a therapeutic protein vaccine ATP150 or ATP 152 ii) a viral vector VSV-GP154 iii) an immune checkpoint inhibitor Ezabenlimab In the second part of the study, researchers will compare treatment group versus observational group.

This is an open-label, phase 1b study to evaluate the safety, tolerability, immunogenicity and preliminary efficacy of a heterologous prime-boost vaccine (protein and viral vector) regimen without/with the PD-1 inhibitor Ezabenlimab. COMPLETED - Part A (metastatic and locally advanced PDAC patients) Cohort A: ATP150/ATP152 and VSV-GP154 treatment ONGOING - Part B (locally advanced and resected PDAC patients) Cohort B: ATP150/ATP152, Ezabenlimab and VSV-GP154 treatment Cohort B1, B2, B3: dose escalation NOT STARTED YET - Part C (resected PDAC patients) Cohort C: ATP150/ATP152, Ezabenlimab and VSV-GP154 treatment (treatment versus observational arm)

Pancreatic Ductal Adenocarcinoma

DRUG: VSV-GP154
DRUG: ATP150
DRUG: ATP152
DRUG: Ezabenlimab

KISIMA-02

Study Record Dates

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.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-04-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-01
First Submitted that Met QC Criteria 2023-05-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-08-06
First Posted (ACTUAL) 2023-05-06	Results First Posted N/A	Last Verified 2024-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Cohort A	DRUG: VSV-GP154 VSV-GP154 DRUG: ATP150 ATP150 DRUG: ATP152 ATP152
EXPERIMENTAL: Cohort B	DRUG: VSV-GP154 VSV-GP154 DRUG: ATP150 ATP150 DRUG: ATP152 ATP152 DRUG: Ezabenlimab Ezabenlimab
EXPERIMENTAL: Cohort C Treatment	DRUG: VSV-GP154 VSV-GP154 DRUG: ATP150 ATP150 DRUG: ATP152 ATP152 DRUG: Ezabenlimab Ezabenlimab
NO_INTERVENTION: Cohort C Observational

Primary Outcome Measures	Measure Description	Time Frame
Occurrence of dose-limiting toxicity (DLT)	Part A and B	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	Throughout the study, on average 2.4 years

Secondary Outcome Measures	Measure Description	Time Frame
Proportion of patients achieving ctDNA clearance	Part C	Up to 12 months
Proportion of patients experiencing ctDNA non-progression	Part C	up to 12 months
Occurrence of dose-limiting toxicity (DLT)	Part C	Throughout the study, up to 7.5 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AMAL Therapeutics

Phone Number: +41 (0) 22 594 39 52

Email: RESContact.GVA@boehringer-ingelheim.com

Participation Criteria

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) with KRAS G12D or KRAS G12V mutation.
ECOG performance status of 0 or 1.
Patients with advanced or metastatic disease who completed at least 16 weeks of standard 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).
Life expectancy at least 12 months (resected PDAC), or at least 6 months (advanced/metastatic PDAC).
Archival tumor tissue availability for central KRAS analysis.

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 (advanced/metastatic PDAC) or 28 (resected PDAC) days from initiation of study treatment.
Prior use of immunotherapeutic agents, including but not limited to checkpoint inhibitors or VSV-based agents.
Diagnosis of immunodeficiency.
Chronic systemic treatment with steroids or other immunosuppressive medications.
Active autoimmune disease requiring systemic treatment within the last 2 years.
Use of Tamoxifen within 1 month prior to start of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Boehringer Ingelheim

Investigators

PRINCIPAL_INVESTIGATOR: Paul Oberstein, MD, NYU Langone Health

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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