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:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT07191405
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent.
2. Age 18-75 years.
3. Histologically confirmed unresectable/metastatic tumors:
EGFR/ALK wild-type adenocarcinoma non-small cell lung cancer (NSCLC) PD-L1+ (CPS≥1) triple-negative breast cancer (TNBC) HER2- gastric/gastroesophageal adenocarcinoma
4. ≥1 measurable lesion (RECIST v1.1).
5. Progression after PD-1/PD-L1 inhibitor therapy (defined as:
* ≥2 doses administred.
* Radiographic progression per RECIST/iRECIST/irRECIST, confirmed ≥4 weeks later.
* Progression within 12 weeks of last PD-1/PD-L1 dose.
6. Adequate organ function.
7. ECOG performance status 0-1.
8. Negative pregnancy test (urine/serum β-HCG) for women of childbearing potential.
Exclusion Criteria:
* 1\. Prior allogeneic transplantation (cells, tissues, or solid organs). 2. History of immune-related adverse events (irAEs) from immunomodulators (e.g., PD-1/PD-L1 or CTLA-4 inhibitors) leading to permanent discontinuation or Grade 3/4 severity.
3\. Recent anticancer therapy (chemotherapy/immunotherapy/biologics/experimental drugs) within: \<5 half-lives of the drug or \<21 days before starting study treatment (whichever is shorter). Exceptions: Stable hormone therapy (e.g., for prostate/breast/ovarian cancer).
4\. Concomitant corticosteroid use (\>10 mg prednisone/day or equivalent) within 7 days prior to treatment, unless for physiological replacement (≤10 mg/day) or non-immunosuppressive purposes (e.g., inhaled/topical steroids).
5\. Severe cardiac dysfunction, including: NYHA Class III-IV heart failure, symptomatic coronary artery disease, severe ventricular arrhythmias, myocardial infarction/unstable angina within 6 months.
6\. Active autoimmune disease requiring systemic treatment (immunosuppressants/corticosteroids) in the past 2 years, except: Hormone replacement (thyroxine, insulin, physiologic corticosteroids).
7\. Active severe infection requiring systemic therapy. 8. Antibiotic use completed within 2 weeks before the first dose. 9. Psychiatric or substance abuse disorders compromising protocol compliance. 10. Live vaccines administered within 28 days before treatment. 11. Active HIV or hepatitis (A/B/C) infection. 12. History of steroid-requiring (non-infectious) pneumonitis or current active pneumonitis.
13\. Other malignancies requiring active treatment or progressing within 2 years (exceptions: Non-melanoma skin cancer, cervical/prostate carcinoma in situ).
14\. Pregnancy or lactation. 15. Known intolerance/allergy to study drugs. 16. Other conditions deemed unsuitable by investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07191405
Study Brief:
Protocol Section:
NCT07191405