Evaluating a new immunotherapy for pancreatic cancer patients with specific KRAS mutations
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)
This study is testing a new combination of immunotherapy treatments for pancreatic cancer patients with specific KRAS mutations to see if it can help them feel better and improve their outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Amal Therapeutics Industry-sponsored |
| Drugs / interventions | chemotherapy, Ezabenlimab, immunotherapy |
| Locations | 15 sites (Los Angeles, California and 14 other locations) |
| Trial ID | NCT05846516 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and efficacy of a novel immunotherapy regimen in patients with pancreatic ductal adenocarcinoma (PDAC) harboring KRAS G12D or G12V mutations. Participants will receive a combination of a therapeutic protein vaccine (ATP150 or ATP152), a viral vector (VSV-GP154), and an immune checkpoint inhibitor (Ezabenlimab). The study is divided into phases, with the first part focusing on safety and tolerability, while the second part will compare treatment outcomes against an observational group. The trial includes both advanced and resected PDAC patients who have undergone prior treatments.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed PDAC and specific KRAS mutations who have completed prior treatments and have no evidence of disease progression.
Not a fit: Patients who are not yet recovered from surgery or have other malignancies within the last three years may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat pancreatic cancer.
How similar studies have performed: Other studies have shown promise with immunotherapy approaches in pancreatic cancer, but this specific combination is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California and 14 other locations
- USC/Norris Comprehensive Center — Los Angeles, California, United States (Recruiting)
- University of California Los Angeles (UCLA) — Los Angeles, California, United States (Recruiting)
- University of Colorado Hospital — Aurora, Colorado, United States (Recruiting)
- University of Florida — Gainesville, Florida, United States (Recruiting)
- Orlando Health — Orlando, Florida, United States (Recruiting)
- Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- START - South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States (Recruiting)
- Virginia Cancer Specialists — Fairfax, Virginia, United States (Recruiting)
- Virginia Mason Medical Center — Seattle, Washington, United States (Recruiting)
- University Hospital of Lausanne (CHUV) — Lausanne, Default, Switzerland (Recruiting)
- University Hospital of Bern (Inselspital) — Bern, Switzerland (Recruiting)
- University Hospitals of Geneva (HUG) — Geneva, Switzerland (Recruiting)
Study contacts
- Principal investigator: Paul Oberstein, MD — NYU Langone Health
- Study coordinator: AMAL Therapeutics
- Email: RESContact.GVA@boehringer-ingelheim.com
- Phone: +41 (0) 22 594 39 52
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.