JPRN-jRCT2031210395招募中1 期
A Phase 1 first in human study evaluating safety, pharmacokinetics and efficacy of ABBV-400 in adult subjects with advanced solid tumors
Yamagishi Chika0 个研究点目标入组 460 人开始时间: 2021年10月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 460
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 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) v1.1.
- •- 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.
- •- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- •- 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.
研究者
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