Testing LBL-024 in patients with advanced malignant tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting
• Anhui Provincial Hospital
  Hefei, Anhui, China Recruiting
• The Second Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting
• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting
• Cancer Hospital Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting
• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: lin Shen — Peking University Cancer Hospital & Institute
• Study coordinator: xue kong
• Email: kongxue@leadsbiolabs.com
• Phone: 025-83378099

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.