A Biomarker Screening Protocol for Participants With Solid Tumors

Trial Title: A Biomarker Screening Protocol for Participants With Solid Tumors

NCT ID: NCT05891197

Condition: 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

Conditions: Official terms:
Carcinoma
Breast Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endometrial Neoplasms
Triple Negative Breast Neoplasms
Fallopian Tube Neoplasms
Cystadenocarcinoma, Serous
Recurrence

Conditions: 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

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Prospective

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.

Criteria for eligibility:

Study pop:
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).

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Locations:

Facility:
Name: Accellacare

Address:
City: Rocky Mount
Zip: 27804
Country: United States

Status: Recruiting

Contact:
Last name: Jackie Walling, MBChB, PhD
Email: clinicaltrials@lyell.com

Start date: May 19, 2023

Completion date: June 2028

Lead sponsor:
Agency: Lyell Immunopharma, Inc.
Agency class: Industry

Collaborator:
Agency: ICON plc
Agency class: Industry

Source: Lyell Immunopharma, Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05891197