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)

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