NCT07015697招募中1 期
A Phase 1, Multicenter Trial of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 32
- 主要终点
- Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)
研究概览
简要总结
This dose escalation and dose expansion study was designed to assess the safety, tolerability, PK and efficacy of subcutaneous T-DXd in participants with metastatic solid tumors.
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
盲法说明
This is an open-label study.
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
- •Adults ≥18 years or the minimum legal adult age (whichever is greater).
- •a) Disease State: If HER2 status is required for eligibility (for all populations), a documented HER2 test result must be available.
- •Breast Cancer: adults with pathologically documented unresectable or metastatic breast cancer HER2-positive BC: have received a prior anti-HER2-based regimen. For HER2-positive BC participants in Part 2 only, prior anti-HER2 based therapy should have been received in either:
- •the metastatic setting, or
- •the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy. HR-, HER2-low BC: have received a prior systemic cytotoxic therapy in the metastatic setting; or developed disease recurrence during or within 6 months of completing (neo)adjuvant chemotherapy. HR+, HER2-low/ultralow BC: have received previous ET AND an additional line of ET must not be the next line of treatment considered in the participant's best interest.
- •For participants in Part 2 with HR+ HER-2low/ultralow BC, the following criteria also apply:
- •had disease progression while receiving 1 previous line of ET with a CDK4/6i and is not expected to benefit from immediate use of a second line of ET, OR
- •had disease progression on at least 2 previous lines of ET with or without a target therapy such as CDK4/6, mTOR or PI3-K inhibitors) administered for the treatment of metastatic disease
- •participants may not have received more than 2 prior lines of cytotoxic therapy in the recurrent or metastatic setting. NSCLC, HER2 mut: adults with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy.
- •b) Part 2 only: At least 1 RECIST 1.1 measurable lesion on CT or MRI.
- •Radiologic or objective evidence of disease progression on or after the last systemic therapy prior to starting trial intervention.
排除标准
- •1. Prior treatment with ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor;
- •Medical history of MI within 6 months before enrollment or symptomatic CHF (New York Heart Association class II to IV). Participants with troponin levels above ULN at screening (as defined by the manufacturer), and without any MI-related symptoms should have a cardiologic consultation during the Screening Period to rule out MI.
- •5. Has a corrected QT interval (QTcF) prolongation to > 480 ms (regardless of participant's sex) based on average of the screening triplicate 12-lead ECG.
- •Has a 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.
研究组 & 干预措施
Part 2 (Dose Expansion)
Experimental
Participants will receive Trastuzumab Deruxtecan subcutaneously at the recommended dose for expansion (RDE)
干预措施: Trastuzumab Deruxtecan (Drug)
Part 1 (Dose Escalation)
Experimental
Participants will receive Trastuzumab Deruxtecan subcutaneously at escalating doses. The recommended dose for expansion (RDE) will be calculated using data collected from this population.
干预措施: Trastuzumab Deruxtecan (Drug)
结局指标
主要结局
Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)
时间窗: From the start of trial intervention to 21 days after the last dose, up to approximately 9 months
TEAEs are defined as those Adverse Events (AEs) with start or worsening date during the on-treatment period (from the first dose date of trial intervention to 21 days after the last dose date of trial intervention).
Area Under Curve (AUC)
时间窗: From the start of trial intervention to last dose, up to approximately 9 months
Number of Participants with Dose limiting toxicities (DLT) During the Dose-Escalation Phase
时间窗: From the start of trial intervention to 21 days after the last dose, up to approximately 9 months
次要结局
- Percentage of Participants with Anti-Drug Antibody (ADAs)(From baseline to post-baseline, up to approximately 12 months)
- Overall Response Rate (ORR)(From the enrollment/randomization date until documented disease progression, up to 12 months)
- Disease Control Rate (DCR)(From the enrollment/randomization date until documented disease progression, up to 12 months)
研究者
研究点 (32)
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