jRCT2031260141招募中不适用
A Phase 1a/1b, Multicenter, Open-label, First-in-human Study of GNX1021 in Subjects with Unresectable Locally Advanced or Metastatic Gastrointestinal Cancers
未提供0 个研究点目标入组 64 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
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
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •to be met for both Phase 1a and Phase 1b:
- •Subjects must be able to understand and voluntarily provide written informed consent and be willing and able to comply with all protocol-specified visits and study-related procedures.
- •Subjects must provide archival formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens collected within the past five years or agree to undergo a fresh biopsy.
- •Subjects must have at least one measurable lesion as defined by RECIST v1.
- •Subjects must be aged >= 18 years at the time of informed consent.
- •Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or
- •Subjects must have an estimated life expectancy of at least 12 weeks.
- •Subjects must have adequate bone marrow and organ function.
- •Female subjects of childbearing potential must agree to use effective contraceptive measures throughout the treatment period and for at least 7 months after the last dose and male subjects whose partners are female of childbearing potential must agree to use effective contraceptive measures throughout the treatment period and for 4 months after the last dose.
- •Inclusion Criteria for Phase 1a:
- •Subjects must have pathologically confirmed unresectable, locally advanced, or metastatic gastrointestinal cancers that have current progressive diseases and no further standard therapy is available.
- •Inclusion Criteria for Phase 1b:
- •Subjects must have histo-pathologically confirmed unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinomas (Cohort A), and metastatic pancreatic ductal adenocarcinoma (Cohort B).
- •For G/GEJ AC, subjects must have:
- •received at least 1 prior line of systemic therapy (anti-PD-(L)1 + platinum/ fluoropyrimidines);
- •received anti-HER2 therapy for HER2 overexpression subjects;
- •For PDAC, subjects must have:
- •received and disease progressed from prior gemcitabine-based systemic chemotherapy for metastatic disease.
- •Subjects must have bLeB/Y-positive tumors as confirmed by central pathological review.
排除标准
- •to be met for both Phase 1a and Phase 1b:
- •Participation in another interventional study (except observational)
- •Prior antineoplastic therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to first dose
- •Planned other anti-tumor therapy during the study (palliative radiotherapy for symptomatic relief that does not affect response assessment is allowed)
- •Strong CYP3A4 inhibitor use within 2 weeks or 5 half-lives (whichever is longer) prior to first dose
- •Live vaccine within 4 weeks prior to enrollment or planned during study
- •Toxicities from prior therapy not recovered to Grade 0/1 (except clinically insignificant)
- •Major surgery within 4 weeks, unhealed wounds, or planned major surgery during the study period
- •Prior whole pelvic radiotherapy
- •Grade >= 2 peripheral neuropathy or active/chronic corneal disorder
- •Gastric pyloric obstruction or persistent vomiting (>= 3 episodes/24 hr)
- •Unresolved GI perforation and/or fistula within 6 months
- •Active CNS metastases
- •Interstitial lung disease, pneumonitis, or uncontrolled/severe pulmonary disease, or suspected of having the above diseases
- •Uncontrolled or clinically significant medical conditions
- •Other active malignancies (Excluding previously treated patients under certain conditions)
- •Immunodeficiency or history of allogeneic transplantation
- •Pregnant, breastfeeding, or unable to exclude pregnancy
研究者
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