Advanced Breast Cancer, Advanced Lung Carcinoma, Endometrial Cancer, Endometrioid Tumor, Fallopian Tube Cancer, High Grade Serous Carcinoma, Non-Small Cell Carcinoma of Lung, TNM Stage 4, Non-small Cell Lung Cancer, Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, NSCLC, NSCLC, Recurrent, NSCLC Stage IV, Ovarian Cancer, Ovarian Epithelial Cancer, Platinum-resistant Ovarian Cancer, Primary Peritoneal Carcinoma, Recurrent Breast Cancer, Recurrent NSCLC, Relapsed Cancer, Relapse/Recurrence, Triple Negative Breast Cancer
Conditions
Keywords
Biomarker Screening, Immunotherapy, CAR-T, CAR T-cell therapy, CAR T, CAR T-cell, ROR1, ROR1+, ROR1 positive, cell therapy, relapsed, refractory, solid tumor, advanced, metastatic, breast cancer, lung cancer, triple negative breast cancer, non small cell lung cancer, ovarian cancer, endometrial cancer
Brief summary
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.
Interventions
None listed
Sponsors
ICON plc
Lyell Immunopharma, Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Participants aged ≥ 18 years at time of informed consent 2. Able to provide informed consent 3. 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. 4. 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
1. Prior solid organ transplantation 2. Prior treatment with any adoptive cell therapy 3. 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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| To explore tumor expression of biomarkers, such as ROR1, by different methods (e.g., IHC versus next-generation sequencing [NGS]) | 5 years |
Countries
United States
Outcome results
None listed