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

January 22, 2024 updated by: Amal Therapeutics

A Phase 1b Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of ATP150/ATP152, VSV-GP154 and Ezabenlimab (BI 754091) in Patients With KRAS G12D/G12V Mutated Pancreatic Ductal Adenocarcinoma (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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Part A (metastatic and locally advanced PDAC patients) Cohort A: ATP150/ATP152 and VSV-GP154 treatment

Part B (locally advanced and resected PDAC patients) Cohort B: ATP150/ATP152, Ezabenlimab and VSV-GP154 treatment

Part C (resected PDAC patients) Cohort C: ATP150/ATP152, Ezabenlimab and VSV-GP154 treatment (treatment versus observational arm)

Study Type

Interventional

Enrollment (Estimated)

85

Phase

  • Phase 1

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

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1205
        • Recruiting
        • University Hospitals of Geneva
        • Principal Investigator:
          • Thibaud Koessler
        • Contact:
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California Los Angeles (UCLA)
        • Contact:
        • Principal Investigator:
          • Zev Aryeh Wainberg, MD
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC/Norris Comprehensive Center
        • Principal Investigator:
          • Heinz-Josef Lenz, MD
        • Contact:
    • Florida
      • Gainesville, Florida, United States, 32610-0278
        • Recruiting
        • University of Florida
        • Contact:
        • Principal Investigator:
          • Thomas J. George, MD
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute
        • Principal Investigator:
          • Anthony Shields, MD,PhD
        • Contact:
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Principal Investigator:
          • Paul Oberstein, MD, MS
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Principal Investigator:
          • Shubham Pant, MD
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists
        • Contact:
        • Principal Investigator:
          • Alexander Spira, MD
    • Washington
      • Seattle, Washington, United States, 98101

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key inclusion criteria

  • 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.

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 (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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort B
Drug: VSV-GP154
Injection
Drug: ATP150
Injection
Drug: ATP152
Injection
Drug: Ezabenlimab
Infusion
Experimental: Cohort A
Drug: VSV-GP154
Injection
Drug: ATP150
Injection
Drug: ATP152
Injection
Experimental: Cohort C Treatment
Drug: VSV-GP154
Injection
Drug: ATP150
Injection
Drug: ATP152
Injection
Drug: Ezabenlimab
Infusion
No Intervention: Cohort C Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of dose-limiting toxicity (DLT)
Time Frame: Over at least 35 days
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.
Time Frame: Throughout the study, on average 2.4 years
Part C
Throughout the study, on average 2.4 years

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Amal Therapeutics

Collaborators

Boehringer Ingelheim

Investigators

  • Principal Investigator: Shubham Pant, MD, M.D. Anderson Cancer Center
  • Principal Investigator: Paul Oberstein, MD, NYU Langone Health

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 Major Dates

Study Start (Actual)

March 13, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KISIMA-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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