进行中(不再招募) NCT04589845

肿瘤不可知精准免疫肿瘤学及体细胞靶向合理配对(TAPISTRY)平台研究

未指定Phase IIIII 期IV 期TMB

TAPISTRY是一项第二期、全球性、多中心、开放标签、多队列研究,旨在评估靶向治疗或免疫治疗作为单药或合理指定联合方案,用于经确效次世代基因测序(NGS)识别出带有特定致癌基因组改变或被确定为肿瘤突变负荷(TMB)高的不可切除、局部晚期或转移性实体瘤参与者的安全性及疗效。

适应症:Solid Tumors

入组条件

纳入标准

  • Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
  • Measurable disease as defined by RECIST v1.1, RANO, or INRC
  • Performance status as follows: Participants aged ≥ 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participants aged 16 to \< 18 years: Karnofsky score ≥ 50%; Participants aged \< 16 years: Lansky score ≥ 50%
  • For participants aged ≥ 18 and \< 18 years: adequate hematologic and end-organ function
  • Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
  • Adequate recovery from most recent systemic or local treatment for cancer
  • Life expectancy ≥ 8 weeks
  • Ability to comply with the study protocol, in the investigator's judgment

排除标准

  • Current participation or enrollment in another therapeutic clinical trial
  • Any anticancer treatment within 2 weeks or 5 half-lives prior to start of study treatment
  • Whole brain radiotherapy within 14 days prior to start of study treatment
  • Stereotactic radiosurgery within 7 days prior to start of study treatment
  • Pregnant or breastfeeding, or intending to become pregnant during the study
  • History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study or confounds the ability to interpret data from the study
  • Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment
  • Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or higher), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina
  • History of another active cancer within 5 years prior to screening that may interfere with the determination of safety or efficacy of study treatment with respect to the qualifying solid tumor malignancy

入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。