NL-OMON51441撤回2 期
TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIAL - BO41932 Tapistry - adults
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 8
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 64（—）
入选标准
- •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.
- •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
- •For patients aged => 18: 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
- •For female patients of childbearing potential: Negative serum pregnancy test
- •=<14 days prior to initiating study treatment; agreement to remain abstinent or
- •use single or combined contraception methods that result in a failure rate of <
- •1% per year for the period defined in the cohort-specific inclusion criteria;
- •and agreement to refrain from donating eggs during the same period
- •For male patients: Willingness to remain abstinent or use acceptable methods
- •of contraception as defined in the cohort-specific inclusion criteria
排除标准
- •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
- •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
- •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
研究者
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