A Biomarker Screening Protocol for Participants With Solid Tumors

NCT05891197 | Terminated

• 1 other identifier: LYLSCR-101
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (1)

• To identify participants whose tumors express biomarkers, such as ROR1, that may inform eligibility for active and future Lyell clinical trials

  5 years

Secondary Outcomes (1)

• To explore tumor expression of biomarkers, such as ROR1, by different methods (e.g., IHC versus next-generation sequencing [NGS])

  5 years

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults 18 years of age or older with histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumor malignancy who are willing to have archival tumor tissue analyzed for biomarker(s).

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

Sponsors & Collaborators

• Lyell Immunopharma, Inc.: lead
• ICON plc: collaborator

Study Sites (1)

Accellacare

Rocky Mount, North Carolina, 27804, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

An Archival 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

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Recurrence; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Endometrial Neoplasms; Carcinoma, Ovarian Epithelial; Neoplasm Metastasis; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Uterine Neoplasms; Uterine Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplastic Processes

Study Officials

• Jackie Walling, MBChB, PhD

  Lyell Immunopharma

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 6, 2023
• Study Start: May 19, 2023
• Primary Completion: February 5, 2025
• Study Completion: February 5, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

US (1)