JPRN-jRCT2031210676进行中（未招募）1 期
A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY OF PF-07265028 AS A SINGLE AGENT AND IN COMBINATION WITH SASANLIMAB EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07265028 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS
Kawai Norisuke0 个研究点目标入组 240 人开始时间: 2022年3月18日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
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
- >= 20age old 至 <= 99age old（—）
- 性别
- All
入选标准
- •Key Inclusion Criteria:
- •Across all cohorts:
- •1.Eastern Cooperative Oncology Group (ECOG) performance status <=1
- •2.Adequate hematological, kidney and liver function
- •3.Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- •4.Resolved acute effects of any prior therapy
- •5.All participants must provide archival formalin-fixed paraffin-embedded (FFPE) tumor tissue:
- •Part 1: If archival sample is older than 6 months, the participant must consent to undergo a fresh biopsy during the screening.
- •Part 2 Fresh tumor biopsy during screening is required unless there is archival tissues less than 3 months old and subsequent to the last systemic anti-cancer therapy.
- •Part 1A Monotherapy:
- •Histologically or cytologically confirmed advanced or metastatic solid tumors which have progressed following systemic anticancer therapies, or are resistant to standard therapy or for which no standard therapy is available, or for whom standard therapy is not tolerated.
- •Part 1B Combination Therapy:
- •Histologically or cytologically confirmed advanced or metastatic solid tumor which have progressed following systemic anticancer therapies, including at least 1 checkpoint inhibitor.
- •Part 2 Dose Expansion:
- •Histologically or cytologically confirmed advanced or metastatic malignancies, including gastric/Gastroesophageal junction cancer, Head and neck squamous cell carcinoma, or urothelial cancer (non-small cell lung cancer and other solid tumors may be included) who have progressed following systemic anticancer therapies, including at least 1 checkpoint inhibitor
排除标准
- •Key Exclusion Criteria:
- •1.Participants with any other active malignancy within 3 years prior to enrollment
- •2.Participants with active autoimmune conditions or history of autoimmune diseases that may relapse
- •3.History of interstitial lung disease, pneumonitis (non-infectious) or uncontrolled lung diseases
- •4.History of prior immune-related adverse events (irAEs) Grade >=3
- •5.Central nervous system metastases
- •6.Significant cardiac or pulmonary conditions or events within previous 6 months
- •7.Active, uncontrolled bacterial, fungal, or viral infection
- •8.Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PF-07265028
研究者
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