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A Phase I/II Clinical Study of LBL-024 in Patients With Advanced Malignant Tumors

RECRUITINGPhase 1/2Sponsored by Nanjing Leads Biolabs Co.,Ltd
Actively Recruiting
PhasePhase 1/2
SponsorNanjing Leads Biolabs Co.,Ltd
Started2022-01-06
Est. completion2026-12
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05170958

Summary

To evaluate the phase I/II clinical study of LBL-024 in the treatment of patients with advanced malignant tumors

Eligibility

Age: 18 Years – 80 YearsHealthy volunteers accepted
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

Conditions2

Advanced Solid TumorCancer

Interventions1

LBL-024 for Injection

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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