Open-Label Phase 2 Study of Ladiratuzumab Vedotin (LV) for Unresectable Locally Advanced or Metastatic Solid Tumors - Phase 2 Study of LV in Advanced Solid Tumors

SEATTLE GENETICS, INC.0 个研究点目标入组 264 人开始时间: 2021年2月1日最近更新: 2021年4月5日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 264

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•All Cohorts of Part A and Part B
•Measurable disease according to RECIST v1.1 as assessed by the investigator
•Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
•Cohort 1: SCLC
•Must have extensive stage disease
•No more than 1 prior line of cytotoxic chemotherapy for extensive disease stage
•May have received prior anti-PD(L)1 therapy
•Cohort 2: NSCLC-squamous
•Must have unresectable locally advanced or metastatic disease
•Must have disease progression during or following systemic therapy
•a. Participants must have progressed during or after a platinum based combination therapy administered for the treatment of metastatic disease
•b. Participants must have progressed within 6 months of last dose of platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for early stage or locally advanced stage disease.
•No more than 1 prior line of cytotoxic chemotherapy for their advanced disease
•Must have received prior anti-PD(L)1 therapy, unless contraindicated
•Cohort 3: NSCLC-nonsquamous
•Must have unresectable locally advanced or metastatic disease
•Must have disease progression during or following systemic therapy
•a. Participants must have progressed during or after a platinumbased combination therapy administered for the treatment of metastatic disease
•b. Participants must have progressed within 6 months of last dose of platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for early stage or locally advanced state disease.
•Must have had prior platinum-based chemotherapy
•No more than 1 prior line of cytotoxic chemotherapy for their advanced disease
•Must have received prior anti-PD(L)1 therapy, unless contraindicated
•Cohort 4: HNSCC
•Must have unresectable locally recurrent or metastatic disease
•Must have disease progression during or following prior line of systemic therapy
•a. Disease progression after treatment with a platinum-containing regimen for recurrent/metastatic disease; or
•b. Recurrence/progression within 6 months of last dose of
•platinum therapy given as part of a multimodal therapy in the curative setting
•No more than 1 line of cytotoxic chemotherapy for their advanced disease
•May have received prior anti-PD(L)1 therapy, unless contraindicated
•Cohort 5: esophageal-squamous
•Must have unresectable locally advanced or metastatic disease
•Must have disease progression during or following systemic therapy
•Must have had prior platinum-based chemotherapy
•No more than 1 line of cytotoxic chemotherapy for their advanced disease
•Cohort 6: gastric and GEJ adenocarcinoma
•Must have unresectable locally advanced or metastatic disease
•Must have received prior platinum-based therapy
•Must have disease progression during or following systemic therapy
•Participants with known human epidermal growth factor receptor 2(HER2) overexpression must have received prior HER2-targeted therapy
•No more than 1 line of prior cytotoxic chemotherapy for their advanced disease
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 158
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 105

排除标准

•All Cohorts of Part A and Part B
•Active concurrent malignancy or a previous malignancy within the past 3 years
•Known active central nervous system lesions
•Any ongoing clinically significant toxicity associated with prior treatment (Grade 2 or higher)
•Ongoing sensory or motor neuropathy of Grade =2
•Has received prior radiotherapy within 2 weeks of start of study treatment

研究者

发起方

SEATTLE GENETICS, INC.

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