A Biomarker Screening Protocol for Participants With Solid Tumors

Stopped early

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT05891197

Run by

Lyell Immunopharma, Inc.

People needed

10

Starts

2023-05-19

Expected to finish

2025-02-05

Last updated by the study team

2025-07-01

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Accellacare — Rocky Mount, North Carolina, United States

Full record on ClinicalTrials.gov

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