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Testing 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

Phase1; Phase2 Interventional Nanjing Leads Biolabs Co.,Ltd · NCT05170958

This study is testing a new drug called LBL-024 to see if it can help people with advanced cancer that hasn't responded to other treatments.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment396 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorNanjing Leads Biolabs Co.,Ltd Industry-sponsored
Locations49 sites (Hefei, Anhui and 48 other locations)
Trial IDNCT05170958 on ClinicalTrials.gov

What this trial studies

This clinical trial is a single-arm, open-label study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of LBL-024 in patients with advanced malignant tumors. It consists of two phases: Phase I/IIa focuses on dose escalation and pharmacokinetic expansion, while Phase IIb is a pivotal single-arm study. Participants must have advanced tumors that have not responded to standard treatments or for which no standard treatment is available. The trial aims to gather data on the drug's effects and safety profile in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with advanced malignant tumors who have failed previous treatments or have no applicable standard treatment options.

Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced malignant tumors who have limited treatment choices.

How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in evaluating new treatments for advanced tumors, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Hefei, Anhui and 48 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Solid Tumor
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.