TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIA

F. Hoffmann-La Roche Ltd0 个研究点目标入组 600 人2021年4月7日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: ocally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are TMB-high as identified by a validated NGS assay
发起方: F. Hoffmann-La Roche Ltd
入组人数: 600
状态: 进行中（未招募）
最后更新: 4年前

暂无简介。

注册库

who.int

开始日期

2021年4月7日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•For patients whose biomarker status is unknown and/or for patients with an ineligible local NGS test result: Signed Biomarker Eligibility Testing Informed Consent Form and willingness to participate in an assigned cohort based on their identified oncogenic biomarker(s)
•For patients with a positive biomarker status: Signed cohort\-specific Informed Consent Form. For pediatric patients: Informed Consent Form must be signed by either the parent(s) or a legal representative
•Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
•Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1\.1 (RECIST v1\.1\), Response Assessment in Neuro\-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)
•Performance status as follows:
•o Patients aged \>\= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0\-2
•o Patients aged 16 to \< 18 years: Karnofsky score \>\= 50%
•o Patients aged \< 16 years: Lansky score \>\= 50%
•For patients 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

•Current participation or enrollment in another therapeutic clinical trial
•Any anticancer treatment within 2 weeks or 5 half\-lives (whichever is longer) 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 patient'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
•Each cohort will also have individual molecule specific inclusion/exclusion criteria