Last updated: October 29, 2022
Sponsor: Second Affiliated Hospital of Soochow University
Overall Status: Active - Not Recruiting
Phase
2
Condition
Carcinoma
Treatment
N/AClinical Study ID
NCT05603013
JD-LK-2022-136-01
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged 18 years and above;
- Diagnosed with histologically or cytologically-confirmed, standard treatment isineffective (disease progresses after treatment) or locally advanced or metastaticmalignant non-small cell lung cancer and breast cancer patients who cannot toleratestandard therapy, cannot receive or do not have standard therapy;
- ECOG(Eastern Cooperative Oncology Group) performance is 0-3;
- Life expectancy greater than 3 months;
- T lymphocyte absolute value ≥0.5 upper limit of normal (ULN), absolute neutrophilcount(ANC)≥1.0 x 10(9)/L#serum aspartate transaminase (AST) and serum alaninetransaminase (ALT) ≤3.0ULN, or AST and ALT≤5ULN with hepatic metastasis; Total serumcreatinine ≤1.5*ULN#
- Signed informed consent form# -
Exclusion
Exclusion Criteria:
- Current pregnancy or lactation# 2. History of other malignant tumors within 5 yearsprior to dose administration, expect for#malignancies that can be cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma insitu, basal or squamous cell skin cancer); 3. Uncontrolled epilepsy, central nervous systemdiseases or mental illness; 4. Currently active clinically significant cardiovasculardisease such as uncontrolled arrhythmia, congestive heart failure, or greater than or equalto Class 2 congestive heart failure as defined by the New York Heart Association FunctionalClassification, or history of myocardial infarction unstable angina, or acute coronarysyndrome within 6 months prior to enrollment in the study; 5. Received allogeneichematopoietic stem cell transplantation or solid organ transplantation; 6. Other serious,uncontrolled concomitant diseases that may affect protocol compliance or interpretation ofoutcomes, including active opportunistic infections or advanced (severe) infections,uncontrolled diabetes; 7. Allergic to any of the ingredients used in the study; 8. Ahistory of immunodeficiency, including HIV positive or other acquired or congenitalimmunodeficiency disease, or a history of organ transplantation, or other immune-relateddisease requiring long-term oral hormone therapy; 9. Acute and chronic tuberculosisinfection; 10. Other disorders with clinical significance according to the researcher'sjudgment.
Study Design
Total Participants: 45
Study Start date:
October 30, 2022
Estimated Completion Date:
October 17, 2024
Connect with a study center
Second Affiliated Hospital of Soochow University
Suzhou,
ChinaSite Not Available

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