Clinical trial NCT05891197: A Biomarker Screening Protocol for Participants With Solid Tumors
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
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
Lead sponsor: Lyell Immunopharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2023-06-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

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.


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

Primary outcomes:
measure: To identify participants whose tumors express biomarkers, such as ROR1, that may inform eligibility for active and future Lyell clinical trials
timeFrame: 5 years
Secondary outcomes:
measure: To explore tumor expression of biomarkers, such as ROR1, by different methods (e.g., IHC versus next-generation sequencing [NGS])
timeFrame: 5 years
Other outcomes:
Locations:
city: Rocky Mount
country: United States
facility: Accellacare
state: North Carolina
Study officials:
affiliation: Lyell Immunopharma
name: Jackie Walling, MBChB, PhD
role: STUDY_CHAIR
References: