Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan in Combination with FOLFOX Compared to Standard of Care in Subjects with First-Line Metastatic Pancreatic Ductal Adenocarcinoma - AndroMETa-PDAC-288
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 194
- 试验地点
- 25
- 主要终点
- Phase 2 and Phase 3: Objective response (OR) assessed by Blinded Independent CentralReview (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
研究概览
简要总结
Phase 2: • To evaluate the safety and tolerability of telisotuzumab adizutecan in combination with FOLFOX • To evaluate the efficacy of telisotuzumab adizutecan in combination with FOLFOX as measured by Objective Response (OR) per Blinded Independent Central Review (BICR) • To optimize and select the recommended Phase 3 dose (RP3D) of telisotuzumab adizutecan in combination with FOLFOX
Phase 3: • To evaluate the efficacy of telisotuzumab adizutecan in combination with FOLFOX compared with standard of care as measured by OR per BICR assessment and by Overall Survival (OS)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Have unresectable, metastatic histologically- or cytologically-confirmed adenocarcinoma of the pancreas
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- •Must consent to provide archived or recently obtained tumor tissue during Screening
- •Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
排除标准
- •Have prior systemic therapy, surgery, or radiation (except palliative radiation) in the unresectable, locally advanced or metastatic setting
- •Prior c-MET targeting therapy
- •History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest CT scan, including a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
- •Prior bone marrow transplant, solid organ transplant, or previous clinical diagnosis of tuberculosis.
研究组 & 干预措施
Telisotuzumab adizutecan
干预措施: Telisotuzumab adizutecan (Drug)
结局指标
主要结局
Phase 2 and Phase 3: Objective response (OR) assessed by Blinded Independent CentralReview (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Phase 2 and Phase 3: Objective response (OR) assessed by Blinded Independent CentralReview (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Phase 3: Overall Survival
Phase 3: Overall Survival
次要结局
- Phase 2 and Phase 3: Progression-Free Survival (PFS) assessed by BICR per RECIST v1.1
- Phase 2 and Phase 3: Duration Of Response (DoR) Assessed by BICR per RECIST v1.1
- Phase 2 and Phase 3: Clinical Benefit (CB) assessed by BICR per RECIST v1.1
- Phase 2 : Overall Survival
- Phase 3: Change from baseline and time to deterioration in scales/items of the EORTC QLQ-C30 and EORTC QLQ-PAN26
- Phase 3: Change in Selected items of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
- Phase 3: Change in GP5 item of the Functional Assessment of Cancer Therapy-General (FACT-G)
- Phase 3: Change in Selected items of Patient Global Impression of Severity (PGIS)/Patient Global Impression of Change (PGIC)
- Phase 3: Change from baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) utility index and visual analog scale (VAS)
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG