JPRN-jRCT2031220404招募中2 期
A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours
Inoguchi Akihiro0 个研究点目标入组 670 人开始时间: 2022年10月21日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 670
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 130age old（—）
- 性别
- All
入选标准
- •Male and female, >= 18 years
- •Documented advanced or metastatic malignancy
- •Eastern Cooperative Oncology Group performance status of 0 or 1 with no deterioration over the 2 weeks prior to baseline or day of first dosing
- •All participants must provide a tumour sample for tissue-based analysis
- •At least 1 measurable lesion not previously irradiated, except Substudy 3 (Prostate Cancer) which allows participants with non measurable bone metastatic disease
- •Adequate bone marrow reserve and organ function
- •Minimum life expectancy of 12 weeks
- •At the time of screening, contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •All women of childbearing potential must have a negative serum pregnancy test documented during screening
- •Female participants must be 1 year post-menopausal, surgically sterile, or using 1 highly effective form of birth control. Female participants must not donate, or retrieve for their own use, ova at any time during this study
- •Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile, avoid intercourse, or use a highly effective method of contraception. Male participants must not freeze or donate sperm at any time during this study.
- •Capable of giving signed informed consent
- •Provision of signed and dated written optional genetic research informed consent prior to collection of samples for optional genetic research that supports the Genomic Initiative
排除标准
- •Any evidence of diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol
- •History of another primary malignancy except for adequately resected basal cell carcinoma or in situ squamous cell carcinoma of the skin, or other solid malignancy treated with curative intent
- •Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved
- •Spinal cord compression or brain metastases unless treated
- •Leptomeningeal carcinomatosis
- •Clinically significant corneal disease
- •Active hepatitis or uncontrolled hepatitis B or C virus infection
- •Uncontrolled infection requiring IV antibiotics, antivirals or antifungals, for example prodromal symptoms
- •Known HIV infection that is not well controlled
- •Active TB infection
- •Significant cardiac diseases
- •History of non-infectious Interstitial lung disease (ILD)/pneumonitis that required steroids
- •Has severe pulmonary function compromise
- •Prior exposure to chloroquine/hydroxychloroquine without an adequate treatment washout period
- •Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention
- •Prior exposure to anticancer therapies without an adequate treatment washout period prior to enrolment or any concurrent anticancer treatment
- •Major surgical procedure or significant traumatic injury within <= 3 weeks of the first dose of study intervention or an anticipated need for major surgery during the study
- •Prior treatment with TROP2-directed Anti-drug antibody, ADC Antibody-drug conjugate (ADCs), other ADCs with deruxtecan payload
- •Severe hypersensitivity to monoclonal antibodies
- •Pregnant, breastfeeding, planning to become pregnant
研究者
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