NCT01522664已完成1 期
A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DEDN6526A in Patients With Metastatic or Unresectable Melanoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 53
- 主要终点
- Maximum tolerated dose/dose-limiting toxicities
研究概览
简要总结
This multicenter, open-label study will assess the safety and pharmacokinetics of DEDN6526A in patients with metastatic or unresectable melanoma. Cohorts of patients will receive escalating doses of DEDN6526A by intravenous infusion on Day 1 of each 21-day cycle. In the absence of disease progression or unacceptable toxicity, patients may continue to receive DEDN6552A for up to 17 cycles (1 year).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Adult patients, >/= 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Histologically confirmed metastatic melanoma (AJCC stage IV) or unresectable melanoma (AJCC Stage III)
- •Prior failure of >/= 1 prior treatment regimens for metastatic or unresectable melanoma due to disease progression or unacceptable toxicity and for whom no standard therapy is available
- •Measurable disease according to RECIST criteria
- •Adequate bone marrow, liver and renal function
- •Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception through the course of the study treatment and for 6 months after the last dose of study treatment
排除标准
- •Treatment with cytotoxic or antibody based therapy within 21 days prior to first dose of study treatment, or with any other anti-cancer therapy within 5 half-lives of the therapy prior to first dose of study treatment
- •Known active infection (including HIV and atypical mycobacterial disease, but excluding fungal infection of the nail beds)
- •Current Grad >/= 2 toxicity (except alopecia or anorexia) from prior therapy
- •Grade >/= 2 peripheral neuropathy
- •History of severe allergic or anaphylactic reactions to monoclonal antibody therapies (or recombinant antibody-related fusion proteins)
- •Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- •Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
- •Evidence of significant uncontrolled concomitant disease or disorder
- •Pregnant or lactating women
- •Prior treatment with any other antibody-drug conjugate (ADC) compound containing monomethyl auristatin E (MMAE) for the treatment of melanoma
- •Previous participation in a clinical trial within 30 days of the day of first study drug administration (Cycle 1, Day 1)
研究组 & 干预措施
Single group
Experimental
干预措施: DEDN6526A (Drug)
结局指标
主要结局
Maximum tolerated dose/dose-limiting toxicities
时间窗: approximately one year after study start
Safety: Incidence of adverse events
时间窗: assessed on an ongoing basis and up to 90 days following last dose of study treatment
Determination of recommended Phase II dose
时间窗: approximately 2 years
次要结局
- Tumor response (tumor assessments according to RECIST criteria)(up to approximately 1 year)
- Anti-therapeutic antibody (ATA) levels(Pre-dose Day 1 Cycles 1-4, and within 30 days post last dose)
- Pharmacokinetics: Area under the concentration-time curve(Pre-dose, 30 min. and 4, 24, 48 hours post-dose and Days 7, 10, 15, 17 Cycles 1-4, pre-dose and 30 min. post-dose Cycle 5 and every other cycle thereafter)
研究者
相似试验
已完成
1 期
A Study to Evaluate the Safety and Pharmacology of DNIB0600A in Participants With Platinum-Sensitive Ovarian Cancer or Non-Squamous Non-small Cell Lung CancerNon-Squamous Non-Small Cell Lung CancerNCT01995188Genentech, Inc.41
进行中（未招募）
1 期
A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid TumorsAdvanced Solid TumorsTriple-Negative Breast Cancer (TNBC)Non-small-cell-lung-cancer (NSCLC)Metastatic Solid TumorsCancerNCT03893955AbbVie150
终止
2 期
A Study of DNIB0600A in Comparison With Pegylated Liposomal Doxorubicin (PLD) in Participants With Platinum-Resistant Ovarian Cancer (PROC)Ovarian CancerNCT01991210Genentech, Inc.95
已完成
1 期
Safety and Pharmacokinetics of Escalating Doses of DNIB0600A in Participants With Non-Small Cell Lung Cancer (NSCLC) and Platinum Resistant Ovarian CancerNon-Small Cell Lung Cancer, Ovarian CancerNCT01363947Genentech, Inc.87
已完成
1 期
A Safety and PK Study of IV EravacyclineBacterial InfectionsNCT03696550Tetraphase Pharmaceuticals, Inc.19