KISIMA-02 vaccine-based immunotherapy for patients with mutated pancreatic cancer

Phase 1

Recruiting

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

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

Brief Summary

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.

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: dose escalation

NOT STARTED YET - Part C (resected PDAC patients) Cohort C: ATP150/ATP152, Ezabenlimab and VSV-GP154 treatment (treatment versus observational arm)

Study Timeline

• Study First Posted: 2024-04-04
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: All
• Target Recruitment: 37

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	ATP150	-
Cohort C Treatment	ATP152	-
Cohort C Treatment	Ezabenlimab	-

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.	Throughout the study, on average 2.4 years	Part C

Secondary Outcome Measures

Name	Time	Method
Proportion of patients experiencing ctDNA non-progression	up to 12 months	Part C
Proportion of patients achieving ctDNA clearance	Up to 12 months	Part C
Occurrence of dose-limiting toxicity (DLT)	Throughout the study, up to 7.5 months	Part C

Trial Locations

Locations (10)

Hospital Universitario Hm Sanchinarro; 🇪🇸 Madrid, Spain

Hospital Universitari Vall D Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Hospital Universitario Reina Sofia; 🇪🇸 Cordoba, Spain

Hospital General Universitario Gregorio Maranon; 🇪🇸 Madrid, Spain

Institut Curie; 🇫🇷 Paris, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Asklepios Kliniken Hamburg GmbH; 🇩🇪 Hamburg, Germany

Universitaetsklinikum Heidelberg AöR; 🇩🇪 Heidelberg, Germany

SLK-Kliniken Heilbronn GmbH; 🇩🇪 Heilbronn, Germany

Hospital Universitario Hm Sanchinarro

🇪🇸Madrid, Spain

Irene Moreno Candilejo

Site contact

917567825

irene.moreno@startmadrid.com