NL-OMON51357尚未招募不适用
A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors - A study of SGN-PDL1V in Advanced Solid Tumors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Seagen Inc.
- 入组人数
- 13
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
- 18 至 99（—）
入选标准
- •- Parts A and B:
- •Participants must have one of the following histologically- or
- •cytologically-confirmed metastatic or unresectable solid tumor types
- •o Non-small cell lung cancer (NSCLC)
- •o Head and neck squamous cell carcinoma (HNSCC)
- •o Triple negative breast cancer (TNBC)
- •o Esophageal squamous cell carcinoma (SCC)
- •Participants must have disease that is relapsed or refractory, that has
- •progressed on approved therapies, be intolerant to or refused such therapies,
- •or such and therapies are contraindicated and in the judgement of the
- •investigator, should have no appropriate SoC therapeutic option
- •Participants must have disease that is relapsed or refractory or be
- •intolerant to SoC therapies and must have one of the following tumor types
- •- Participants with HNSCC must have histologically or cytologically-confirmed
- •SCC of the head and neck
- •o Esophageal SCC
- •o Ovarian cancer
- •- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- •- Measurable disease per RECIST v1.1 at baseline
排除标准
- •- History of another malignancy within 3 years of first dose of study
- •treatment or any evidence of residual disease from a previously diagnosed
- •malignancy.
- •- Known active central nervous system metastases. Participants with
- •previously-treated brain metastases may participate provided they:
- •Are clinically stable for at least 4 weeks prior to study entry after brain
- •metastasis treatment
- •Have no new or enlarging brain metastases
- •And are off of corticosteroids prescribed for symptoms associate with brain
- •metastases for at least 7 days prior to first dose of study treatment
- •- Lepto-meningeal disease
- •- Prior treatment with an anti-PD-L1 agent within less than 5 half-lives.
- •- Previous receipt of an monomethylauristatin E (MMAE)-containing agent.
- •- Pre-existing neuropathy >=Grade 2 per National Cancer Institute Common
- •Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
研究者
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