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

a study on Pancreatic Ductal Adenocarcinoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Zev Aryeh Wainberg, MD (ucla)

Description

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.

Official Title

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)

Details

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)

Keywords

Pancreatic Ductal Adenocarcinoma, KISIMA-02, PDAC, ATP150, ATP152, Ezabenlimab, VSV-GP154, Adjuvant setting, Resected pancreatic ductal adenocarcinoma, Metastatic pancreatic ductal adenocarcinoma, Locally advanced pancreatic ductal adenocarcinoma, Resected PDAC, Metastatic PDAC, LAPC, Adenocarcinoma

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

Locations

  • University of California Los Angeles (UCLA) accepting new patients
    Los Angeles California 90095 United States
  • USC/Norris Comprehensive Center accepting new patients
    Los Angeles California 90033 United States

Lead Scientist at University of California Health

  • Zev Aryeh Wainberg, MD (ucla)
    HS Clinical Professor, Medicine. Authored (or co-authored) 153 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amal Therapeutics
ID
NCT05846516
Phase
Phase 1 Pancreatic Ductal Adenocarcinoma Research Study
Study Type
Interventional
Participants
Expecting 85 study participants
Last Updated