NCT06271837进行中（未招募）2 期
A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) as Monotherapy or in Combination With Anti-cancer Agents for the Treatment of Patients With Selected HER2-expressing Tumors (DESTINY PanTumor03)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 127
- 试验地点
- 29
- 主要终点
- Confirmed Objective Response Rate (ORR)
研究概览
简要总结
This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of trastuzumab deruxtecan as monotherapy or in combination with anti-cancer agents for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2-expressing solid tumors which are not eligible for curative therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This study is Open-Label Study.
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age.
- •Locally advanced, unresectable, or metastatic solid tumors based on most recent imaging.
- •HER2 expression.
- •ECOG performance status of 0-
- •Must provide an adequate FFPE tumor sample to centrally determine HER2 status and other correlatives.
- •Has measurable target disease assessed by the investigator based on RECIST 1.
- •Adequate organ function and bone marrow within 14 days before enrollment.
- •Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Capable of giving signed informed consent.
- •Provision of signed and dated written ICF prior to mandatory study-specific procedures, sampling, or analyses.
- •Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner.
排除标准
- •Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the gastric body or gastroesophageal junction.
- •Has substance abuse or any other medical conditions that may interfere with the patient's participation in the clinical study or evaluation of the clinical study results.
- •A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and concentrated ascites reinfusion therapy.
- •History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated.
- •Has unresolved toxicities from previous anti cancer therapy.
- •Has any spinal cord compression, leptomeningeal disease, or clinically active CNS metastases.
- •Uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals, or active infection including tuberculosis.
- •Active primary immunodeficiency, known uncontrolled active HIV infection, or active Hepatitis B or C infection.
- •Protocol-defined inadequate cardiac function.
- •History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- •Has a concomitant medical condition that would increase the risk of toxicity in the opinion of the investigator.
- •Anti cancer chemotherapy without an adequate treatment washout period prior to enrollment.
- •Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study.
- •Known allergy or hypersensitivity to study treatment or any excipients of the product or other mAbs.
- •Involvement in the planning and/or conduct of the study.
- •Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
- •Previous enrollment in the present study. Concurrent enrollment in another therapeutic clinical study (excluding observational studies).
- •For females only: Currently pregnant or breast feeding, or who are planning to become pregnant.
研究组 & 干预措施
Part 3
Experimental
HER2 IHC 3+ or 2+ cervical cancer
干预措施: Bevacizumab (Drug)
Part 1
Experimental
HER2 IHC 3+ solid tumors (excluding breast and gastric cancer)
干预措施: Trastuzumab deruxtecan (Drug)
Part 3
Experimental
HER2 IHC 3+ or 2+ cervical cancer
干预措施: Trastuzumab deruxtecan (Drug)
Part 2 Cohort A
Experimental
HER2 IHC 2+ solid tumors (excluding breast and gastric cancer)
干预措施: Trastuzumab deruxtecan (Drug)
Part 2 Cohort B
Experimental
HER2 IHC 1+ gynecologic cancers
干预措施: Trastuzumab deruxtecan (Drug)
结局指标
主要结局
Confirmed Objective Response Rate (ORR)
时间窗: An average of approximately 12 months
Confirmed ORR is the proportion of patients who have a confirmed complete response or confirmed partial response per RECIST 1.1.
次要结局
- Progression-free survival (PFS)(An average of approximately 12 months)
- Immunogenicity of T-DXd(An average of approximately 12 months)
- Duration of Response (DoR)(An average of approximately 12 months)
- Disease control rate (DCR)(An average of approximately 12 months)
- Overall survival (OS)(An average of approximately 12 months)
- Occurrence of adverse events (AEs) and serious adverse events (SAEs)(An average of approximately 12 months)
- Pharmacokinetics (PK) of T-DXd(An average of approximately 12 months)
- Confirmed best objective response (BOR)(An average of approximately 12 months)
研究者
研究点 (29)
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