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

• Status: Recruiting
• Trial end date: 2027-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amal Therapeutics
• Collaborator: Boehringer Ingelheim

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