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

Phase 1

Recruiting

• Conditions: KRAS G12D/G12V Mutated Pancreatic Ductal Adenocarcinoma
• Interventions: Drug: VSV-GP154; Drug: ATP150; Drug: ATP152; Drug: ATP162; Drug: Ezabenlimab

• Registration Number: 2022-501854-12-01
• Lead Sponsor: Amal Therapeutics S.A.

Brief Summary

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.

Detailed Description

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, B4: dose escalation

NOT STARTED YET - Part C (resected PDAC patients) Cohort C: ATP162, and VSV-GP154 treatment in combination with Ezabenlimab. (treatment versus observational arm)

Study Timeline

• Study Start: 2023-03-13
• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-05-04
• Study First Posted: 2023-05-06
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-12
• Last Update Posted: 2025-09-18
• Primary Completion: 2028-06
• Study Completion: 2029-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort A	VSV-GP154	-
Cohort A	ATP150	-
Cohort A	ATP152	-
Cohort B	VSV-GP154	-
Cohort B	ATP150	-
Cohort B	ATP152	-
Cohort B	Ezabenlimab	-
Cohort C Treatment	VSV-GP154	-
Cohort C Treatment	Ezabenlimab	-
Cohort C Treatment	ATP162	-

Primary Outcome Measures

Name	Time	Method
Occurrence of dose-limiting toxicity (DLT)	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.	Through study completion, an average of 24 months.	Part C

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with clearance and normalization of tumor biomarkers	Up to 12 months	Part B and C
Occurrence of dose-limiting toxicity (DLT) during the on-treatment period	Throughout the study, up to 12 months.	Part B and C

Trial Locations

Locations (20)

USC/Norris Comprehensive Center; 🇺🇸 Los Angeles, California, United States

University of California Los Angeles (UCLA); 🇺🇸 Los Angeles, California, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Orlando Health; 🇺🇸 Orlando, Florida, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

START - South Texas Accelerated Research Therapeutics; 🇺🇸 San Antonio, Texas, United States

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