A Phase 1b Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Heterologous Prime Boost Vaccination (ATP150/ATP152/ATP162, VSV-GP154) and Ezabenlimab (BI 754091) in Patients With Pancreatic Ductal Adenocarcinoma.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 59
- 试验地点
- 21
- 主要终点
- Occurrence of dose-limiting toxicity (DLT)
研究概览
简要总结
This study has stopped recruitment.
Adults with advanced pancreatic cancer participate in this study. The study tests a type of immunotherapy. It is a protein treatment (ATP150/ATP152/ATP162) combined with a virus (VSV-GP154) that may kill cancer cells and help the immune system fight cancer. The immunotherapy is combined with a study medicine called ezabenlimab. Ezabenlimab is an antibody that may also help the immune system fight cancer.
The purpose is to find the highest dose of the immunotherapy that people with pancreatic cancer can tolerate when taken alone or together with ezabenlimab (Part A and B). To find out, researchers look at the number of participants with certain severe health problems. The original purpose of the subsequent Part C was to check whether the immunotherapy combined with ezabenlimab may increase survival and prevent the cancer getting worse over time. The recruitment into Part C was not continued and stopped.
Participants can stay in the study as long as they tolerate the treatment or up to 1 year. During that time, they regularly visit the site. At all visits, the doctors closely check the health of the participants and note any severe health problems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC)
- •ECOG performance status of 0 or
- •Patients with advanced or metastatic disease who completed at least 16 weeks of standard of care 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).
- •Patient must have completed 8-12 cycles of FOLFIRINOX or mFOLFIRINOX either as adjuvant, neoadjuvant, or perioperative (Part C)
- •Life expectancy at least 12 months (resected PDAC), or at least 6 months (advanced/metastatic PDAC).
- •Archival tumor tissue availability for central KRAS analysis and research.
排除标准
- •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 days (advanced/metastatic PDAC). No prior radiotherapy. in resected PDAC
- •Prior use of immunotherapeutic agents, including but not limited to checkpoint inhibitors or VSV-based agents.
- •Diagnosis of immunodeficiency, and/or history of allogeneic organ transplant
- •Chronic systemic treatment with steroids or other immunosuppressive medications.
- •Active autoimmune disease requiring systemic treatment within the last 2 years.
- •Chronic or concurrent active infectious disease requiring systemic antibodies, antifungal, or antiviral treatment
- •Major (according to the Investigator's judgment) surgery within 12 weeks from initiation of study treatment
- •Use of Tamoxifen within 1 month prior to start of study treatment
研究组 & 干预措施
Cohort B
干预措施: ATP152 (Drug)
Cohort B
干预措施: Ezabenlimab (Drug)
Cohort C Treatment
干预措施: VSV-GP154 (Drug)
Cohort C Treatment
干预措施: Ezabenlimab (Drug)
Cohort C Treatment
干预措施: ATP162 (Drug)
Cohort B
干预措施: VSV-GP154 (Drug)
Cohort A
干预措施: VSV-GP154 (Drug)
Cohort C Observational
Cohort A
干预措施: ATP150 (Drug)
Cohort A
干预措施: ATP152 (Drug)
Cohort B
干预措施: ATP150 (Drug)
结局指标
主要结局
Occurrence of dose-limiting toxicity (DLT)
时间窗: Over at least 35 days
Part A and B
Occurrence of dose-limiting toxicity (DLT)
时间窗: Over at least 35 days
Part A and B
Disease-free survival (DFS), defined as the time from randomization until confirmed relapse or death from any cause, whichever occurs earlier.
时间窗: Through study completion, an average of 24 months.
Part C
次要结局
- Proportion of patients with clearance and normalization of tumor biomarkers(Up to 12 months)
- Occurrence of dose-limiting toxicity (DLT) during the on-treatment period(Throughout the study, up to 12 months.)