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NCT05170958
A Phase I/II Clinical Study of LBL-024 in Patients With Advanced Malignant Tumors
Conditions: Advanced Solid Tumor
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 396
Sponsor: Nanjing Leads Biolabs Co.,Ltd
Location: The First Affiliated Hospital of Anhui Medical University Hefei Anhui
Summary
To evaluate the phase I/II clinical study of LBL-024 in the treatment of patients with advanced malignant tumors
Eligibility Criteria
Inclusion Criteria:
1. Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form;
2. 18-75 years old (including boundary value), no gender limit in the I/IIa trial phase;18-80 years old (including boundary value), no gender limit in the IIb trial phase;
3. Subject has adequate organ and bone marrow function,Conforming to laboratory test results:
4. The expected survival time is at least 12 weeks
5. ECOG score is 0-1
6. Males with fertility and females of childbearing age are willing to take effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception Sets,etc); Women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.
Exclusion Criteria:
1. Receiving other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;
2. Brain parenchymal metastases or meningeal metastases with clinical symptoms, which are not suitable for inclusion in the group by the investigator's judgment;
3. medical history of immunodeficiency including positive HIV antibody test;
4. Women who are pregnant or breastfeeding;
5. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study
Source: ClinicalTrials.gov (NCT05170958). StuddyBuddy aggregates publicly available trial information.