jRCT2031210395招募中不适用
A Phase 1 first in human study evaluating safety, pharmacokinetics and efficacy of ABBV-400 in adult subjects with advanced solid tumors
AbbVie G.K.0 个研究点目标入组 50 人开始时间: 2021年12月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 主要终点
- Objective Response Rate (ORR)
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
- Single Arm Study
- 干预模型
- Single 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
- •Histologic malignant solid tumor diagnosis (World Health Organization [WHO] criteria).
- •Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.
- •For Part 1 only - history of advanced solid tumor that has progressed on all standard of care therapy and are not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
- •For Part 2 only - history of advanced non-squamous wtEGFR or mutEGFR or history of advanced squamous Non-Small Cell Lung Cancer (NSCLC) that have progressed after treatment with at least:
- •Platinum-based chemotherapy and an immune checkpoint inhibitor and/or appropriate targeted therapy for an actionable gene alteration, if applicable, for non-squamous wtEGFR and squamous NSCLC (Parts 2i and 2iii).
- •Platinum-based chemotherapy doublet and tyrosine kinase inhibitor(s) (TKI[s]) for non- squamous mutEGFR NSCLC (Part 2ii).
- •Should have no more than 2 lines of prior cytotoxic chemotherapy excluding adjuvant therapy and must have advanced NSCLC that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
- •For Part 3 only - history of advanced histopathologically or cytologically confirmed diagnosis of gastroesophageal adenocarcinoma/gastroesophagel junction adenocarcinoma (GEA) that has progressed after treatment with at least 1 prior cytotoxic chemotherapeutic regimen for locally advanced or metastatic disease and have not received more than 2 prior lines of cytotoxic chemotherapy regimens. Participants must have progressed on
- •If applicable, an immune checkpoint inhibitor.
- •If applicable, appropriate available therapies, including HER2-directed therapies.
- •For Part 4 only - Participants with history of advanced histopathologically or cytologically confirmed colorectal cancer (CRC) that does not harbor the BRAF V600E mutation and are not dMMR+/MSI-Hi with progression on:
- •A fluoropyrimidine (e.g., 5-fluorouracil or capecitabine).
- •Oxaliplatin.
- •Irinotecan.
- •If applicable, anti-EGFR (including, but not limited to cetuximab or panitumumab).
- •If applicable, anti-vascular endothelial growth factor (VEGF) monoclonal antibody (including but not limited to bevacizumab, ramucirumab, or aflibercept).
- •If applicable, targeted therapy
- •Participants who are considered ineligible for or are intolerant of standard therapy per investigator are eligible. Prior treatment with Lonsurf or Regorafenib is also acceptable.
- •For Part 5 only - participants with advanced histologically or cytologically confirmed solid tumors characterized by MET amplification who are not amenable to surgical resection and who have disease progression after at least one prior systemic therapy and/or who have no satisfactory alternative treatment options. Participants who are intolerant to standard treatment are eligible.
- •For Part 6 only - Participants with advanced histologically or cytologically confirmed solid tumors harboring MET mutations including: mutations in the tyrosine kinase domain, the juxtamembrane region and the extracellular domain (as locally determined by next-generation sequencing (NGS) or a validated qPCR on tissue), who are not amenable to surgical resection and who have disease progression after at least one prior systemic therapy and/or who have no satisfactory alternative treatment options.
- •Intolerant to the standard treatment are eligible
- •For Part 7 (CRC combination) only: Participants with history of advanced histopathologically or cytologically confirmed CRC that does not harbor the mutation and are not dMMR+/MSI-H with progression on:
- •A fluoropyrimidine (e.g., 5-fluorouracil or capecitabine)
- •Oxaliplatin
- •Irinotecan
- •If applicable, anti-EGFR (including, but not limited to cetuximab or panitumumab)
- •If applicable, anti-vascular endothelial growth factor (VEGF) monoclonal antibody (including but not limited to bevacizumab, ramucirumab, or aflibercept)
- •If applicable, targeted therapy Participants who are considered ineligible for or are intolerant of standard therapy per investigator are eligible. Participants treated previously with TAS-102 or regorafenib are not eligible.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or
- •Laboratory values meeting the criteria outlined in the protocol.
排除标准
- •History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis.
- •History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
- •History of clinically significant, intercurrent lung-specific illnesses.
- •For Part 7 only: Prior TAS-102 or regorafenib treated participants are not eligible.
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to Month 24
ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
次要结局
- Duration of Response (DOR)(Up to 24 Months)
- Overall survival (OS)(Up to 24 Months)
- Progression free survival (PFS)(Up to 24 Months)
研究者
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