A Biomarker Screening Protocol for Participants With Solid Tumors

Study Overview
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Brief Summary
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Biomarker Screening Protocol for Preliminary Eligibility Determination for Adoptive T-cell Therapy Trials:This is a decentralized, multi-site, US-based biomarker screening study to identify participants who have specific disease indications and tumor expression of target(s) of interest that may inform eligibility for active and future Lyell clinical trials. No investigational treatments will be administered in this non-interventional screening study. Only previously obtained archival tumor tissue will be allowed on this study for biomarker analysis. Fresh tumor biopsies are not permitted on this study. The study will be conducted virtually and participants will utilize telehealth and e-consent modules. If participants tumors express the biomarkers of interest they can be referred to open and enrolling clinical trials. Participation on the screening study does not guarantee enrollment or treatment on an interventional clinical trial.

Official Title
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A Biomarker Screening Protocol to Support Preliminary Eligibility for Clinical Trials Evaluating Safety and Efficacy of Adoptive T-cell Therapies in Participants With Solid Tumors

Conditions
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Triple Negative Breast Cancer, Nonsmall Cell Lung Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants aged ≥ 18 years at time of informed consent Able to provide informed consent Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumor malignancy.The Sponsor will indicate which solid tumor disease indications are open to enrollment. Ability to provide a tumor tissue sample collected within 3 years prior to enrollment. The sample must consist, at minimum, of 5 freshly cut, unstained 4-5 μM sections cut from a formalin-fixed paraffin-embedded (FFPE) tissue block. The sample must contain sufficient tumor tissue to allow for the evaluation of biomarker expression Exclusion Criteria: Prior solid organ transplantation Prior treatment with any adoptive cell therapy Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with a clinical study, as judged by the Investigator or Sponsor's Medical Monitor

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify participants whose tumors express biomarkers, such as ROR1, that may inform eligibility for active and future Lyell clinical trials |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore tumor expression of biomarkers, such as ROR1, by different methods (e.g., IHC versus next-generation sequencing [NGS]) |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarker Screening, Immunotherapy, CAR-T, ROR1