Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT03319459
Eligibility Criteria:
Inclusion Criteria:
1. Regimen A only (monotherapy): Subjects with advanced metastatic solid tumors
2. Regimen B only (combination with trastuzumab): Subjects with advanced metastatic HER2+ solid tumors
3. Regimen C only (combination with cetuximab): Subjects with advanced metastatic EGFR+ solid tumors
4. Available related donor who is CMV+ and HLA-haploidentical or better but not fully HLA-matched
5. Presence of measurable disease by RECIST 1.1
6. Life expectancy of at least 3 months.
7. Provision of signed and dated informed consent form (ICF).
8. Stated willingness to comply with study procedures and duration.
Exclusion Criteria:
1. Females of reproductive potential that are pregnant or lactating, and males or females not willing to use a highly effective form of contraception from Screening through the end of the study.
2. Eastern Cooperative Oncology Group (ECOG) performance status \>2.
3. Evidence of insufficient organ function as determined by the protocol.
4. Receipt of any biological therapy, chemotherapy, or radiation within 1 week of the Screening Visit and at least 3 weeks prior to Day 1, except for patients receiving maintenance trastuzumab.
5. Have central nervous system disease (CNS) as follows:
1. Dose Escalation Cohorts: Active CNS disease, including history of CNS metastases.
2. MTD/MFD Expansion Cohorts: CNS disease, including history of CNS metastases, that was not stable during the last 6 months.
6. Myocardial infarction (MI) within 6 months of Screening Visit.
7. Severe asthma.
8. Currently receiving or likely to require systemic immunosuppressive therapy from Day -7 to Day 29.
9. Uncontrolled infections.
10. Presence of any medical or social issues that are likely to interfere with study conduct, or may cause increased risk to subject.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03319459
Study Brief:
Protocol Section:
NCT03319459