A Biomarker Screening Protocol for Participants With Solid Tumors

Triple Negative Breast Cancer Clinical Trial

— START  

Official title:

A Biomarker Screening Protocol to Support Preliminary Eligibility for Clinical Trials Evaluating Safety and Efficacy of Adoptive T-cell Therapies in Participants With Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05891197
• Other study ID #: LYLSCR-101
• Status: Recruiting
• Start date: May 19, 2023
• Est. completion date: June 2028

Study information

• Verified date: February 2024
• Source: Lyell Immunopharma, Inc.
• Contact: Jackie Walling, MD, PhD
• Phone: 888-707-7917
• Email: clinicaltrials[@]lyell.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Nonsmall Cell Lung Cancer
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Locations

Country	Name	City	State
United States	Accellacare	Rocky Mount	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Lyell Immunopharma, Inc.	ICON plc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify participants whose tumors express biomarkers, such as ROR1, that may inform eligibility for active and future Lyell clinical trials		5 years
Secondary	To explore tumor expression of biomarkers, such as ROR1, by different methods (e.g., IHC versus next-generation sequencing [NGS])		5 years