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


Amal Therapeutics

Status and phase

Phase 1


Pancreatic Ductal Adenocarcinoma


Drug: ATP150
Drug: Ezabenlimab
Drug: VSV-GP154
Drug: ATP152

Study type


Funder types




Details and patient eligibility


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.

Full 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)


85 estimated patients




18+ years old


No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose




Interventional model

Sequential Assignment


None (Open label)

85 participants in 4 patient groups

Cohort A
Experimental group
Drug: ATP152
Drug: VSV-GP154
Drug: ATP150
Cohort B
Experimental group
Drug: ATP152
Drug: VSV-GP154
Drug: Ezabenlimab
Drug: ATP150
Cohort C Treatment
Experimental group
Drug: ATP152
Drug: VSV-GP154
Drug: Ezabenlimab
Drug: ATP150
Cohort C Observational
No Intervention group

Trial contacts and locations



Central trial contact

AMAL Therapeutics

Data sourced from

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