A Biomarker Screening Protocol for Participants With Solid Tumors

Launched by LYELL IMMUNOPHARMA, INC. · May 26, 2023

Keywords

ClinConnect Summary

**Clinical Trial Summary: Biomarker Screening for Solid Tumors**

This clinical trial is focused on a screening process that helps identify patients with specific types of solid tumors, such as advanced breast cancer, lung cancer, and ovarian cancer, who might qualify for future clinical trials involving a treatment called adoptive T-cell therapy. Importantly, this study does not involve any new treatments at this stage; instead, it looks at previously collected tumor samples to find out if they have certain markers that could indicate eligibility for other trials. The screening will be done remotely, meaning you can participate from home using telehealth technology.

To be eligible for this screening, participants need to be at least 18 years old and have a confirmed diagnosis of an advanced or metastatic solid tumor. Additionally, they must be able to provide a tumor tissue sample that was taken within the last three years. It's important to note that just because someone participates in this screening doesn't guarantee they will be able to join a clinical trial later on. Overall, this study aims to help researchers better understand which patients are suitable for specific treatments in the future.

Gender

ALL

Eligibility criteria

• 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