A Biomarker Screening Protocol for Participants With Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-19

Study Completion Date

2025-02-05

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.

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Detailed Description

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Conditions

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Triple Negative Breast Cancer Non-small Cell Lung Cancer Non Small Cell Lung Cancer Non Small Cell Lung Cancer Metastatic Non-Small Cell Carcinoma of Lung, TNM Stage 4 Advanced Breast Cancer Advanced Lung Carcinoma NSCLC NSCLC, Recurrent NSCLC Stage IV Relapsed Cancer Relapse/Recurrence Recurrent Breast Cancer Recurrent NSCLC Platinum-resistant Ovarian Cancer Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Cancer Endometrial Cancer Endometrioid Tumor High Grade Serous Carcinoma Ovarian Epithelial Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No