jRCT2031240303暂停不适用
A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors (J5I-OX-JZYA)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 420
- 主要终点
- Recommended phase 2 dose (RP2D) or optimal dose
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Have one of the following solid tumor cancers:
- •Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer
- •Cohort A2/B1/B2: urothelial carcinoma
- •Cohort C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, head and neck squamous cell carcinoma, esophageal cancer, pancreatic cancer, or prostate cancer
- •Prior Systemic Therapy Criteria:
- •Cohort A1/C: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies
- •Cohort A2/B1/B2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.
- •Prior enfortumab vedotin specific requirements:
- •Cohorts A1/A2/C: prior treatment with enfortumab vedotin is allowed, but not required
- •Cohort B1: individual must be enfortumab vedotin naive in the advanced/metastatic setting
- •Cohort B2: individual must have received enfortumab vedotin in the metastatic/advanced setting.
- •Measurability of disease
- •Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)
- •Cohorts A2, B1, B2, C: measurable disease required as defined by RECIST v1.1
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations
排除标准
- •Individual with known or suspected uncontrolled CNS metastases
- •Individual with uncontrolled hypercalcemia
- •Individual with uncontrolled diabetes
- •Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant
- •Any serious unresolved toxicities from prior therapy
- •Significant cardiovascular disease
- •Recent thromboembolic event or bleeding disorder
- •Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) >= 470 ms
- •History of pneumonitis/interstitial lung disease
- •History of Grade >=3 skin toxicity when receiving enfortumab vedotin
- •Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention
结局指标
主要结局
Recommended phase 2 dose (RP2D) or optimal dose
时间窗: Cycle 1 (21 Days)
Number of participants with dose-limiting toxicities (DLTs)
Overall response rate (ORR)
时间窗: Up to Approximately 48 Months or 4 Years
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
次要结局
未报告次要终点
研究者
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