RecruitingPhase 1Phase 2NCT05170958
A Phase I/II Clinical Study of LBL-024 in Patients With Advanced Malignant Tumors
A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-024 in Patients With Advanced Malignant Tumors
Sponsor
Nanjing Leads Biolabs Co.,Ltd
Enrollment
396 participants
Start Date
Jan 6, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
To evaluate the phase I/II clinical study of LBL-024 in the treatment of patients with advanced malignant tumors
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria6
- Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form;
- 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；
- Subject has adequate organ and bone marrow function，Conforming to laboratory test results:
- The expected survival time is at least 12 weeks
- ECOG score is 0-1
- 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 Criteria5
- Receiving other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;
- Brain parenchymal metastases or meningeal metastases with clinical symptoms, which are not suitable for inclusion in the group by the investigator's judgment;
- medical history of immunodeficiency including positive HIV antibody test;
- Women who are pregnant or breastfeeding;
- The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study
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Interventions
DRUGLBL-024 for Injection
LBL-024 was given every three weeks for treatment
Locations(49)
View Full Details on ClinicalTrials.gov
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NCT05170958
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