NCT03872206已完成1 期
A Phase 1/2a Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN536 in Patients With Advanced Cancers Associated With Mesothelin Expression Who Have Failed Standard Available Therapy
Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)31 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2019年4月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 31
- 主要终点
- Assessment of Adverse Events by CTCAE 5.0 of HPN536
研究概览
简要总结
An open-label, Phase 1/2a study of HPN536 as monotherapy to assess the safety, tolerability and PK in patients with advanced cancers associated with mesothelin expression.(Phase 2 portion of the study was not conducted.)
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
- •One of the following progressive advanced or metastatic cancers:
- •Epithelial ovarian, fallopian tube, or primary peritoneal cancer that is platinum refractory or platinum resistant
- •Pancreatic adenocarcinoma that is locally advanced, and now with progressive disease on or after front-line treatment
- •Malignant mesothelioma with epithelioid histology, pleural or peritoneal
- •For Part 2 only - Measurable disease according to RECIST v1.1 for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer, pancreatic adenocarcinoma, and peritoneal mesothelioma, and mRECIST v1.1 for patients with pleural mesothelioma
- •Available archival tissue sample, or fresh biopsy tissue sample must be obtained prior to enrollment. For Part 2 only- a fresh biopsy tissue sample is required.
- •Adequate bone marrow function, including:
- •Absolute neutrophil count (ANC) ≥1500/mm3 or ≥1.5 x 109/L
- •Platelets ≥100,000/mm3 or ≥100 x 109/L
- •Hemoglobin (Hgb) ≥9 g/dL
- •Adequate renal function, including estimated creatinine clearance ≥30 mL/min
- •Adequate liver function, including:
- •Total serum bilirubin ≤1.5 x upper limit of normal (ULN) unless the patient has documented Gilbert syndrome in which case the maximum total serum bilirubin should be <5 mg/dL
- •Aspartate and alanine transaminase (AST and ALT) ≤2.5 x ULN or AST/ALT ≤5 x ULN for patients with liver metastases
- •Serum albumin ≥30 mg/mL
排除标准
- •Brain metastases unless previously treated. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, and have no evidence of new or enlarging brain metastases
- •Evidence of retroperitoneal fibrosis, mesothelial surface (pleura, pericardium, peritoneum) thickening of ≥4 mm; significant or increasing pleural/pericardial effusions, ascites or pericarditis at baseline deemed unrelated to the underlying malignancy based on computed tomography (CT), magnetic resonance imaging (MRI), or echocardiogram (ECHO); or prior history of pleurodesis, retroperitoneal fibrosis or mediastinal fibrosis.
- •Previous Grade 3/4 infusion or hypersensitivity reaction (not immunotoxicity) to treatment with another monoclonal antibody.
- •For patients with tumor types other than pleural mesothelioma: Ascites requiring >1 paracentesis for therapeutic purposes (i.e., not for diagnosis) within 1 month prior to Cycle 1 Day 1.
结局指标
主要结局
Assessment of Adverse Events by CTCAE 5.0 of HPN536
时间窗: 3 years
Assess safety and tolerability at increasing dose levels of HPN536 in successive cohorts of patients with of patients with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, pancreatic adenocarcinoma, or mesothelioma (pleural and primary peritoneal) by adverse events (CTCAE v5.0)
Efficacy of HPN536 at the recommended Phase 2 dose: overall response rate (ORR)
时间窗: 1 year
Evaluate overall response rate (ORR) as assessed by RECIST
Determine MTD/RP2D
时间窗: 2 years
Estimate the maximum tolerated dose (MTD) or select the recommended Phase 2 dose (RP2D)
次要结局
未报告次要终点
研究者
研究点 (31)
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