Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05170958

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Advanced Solid Tumor

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Anhui Provincial Hospital, Hefei, Anhui, China

Loading trial locations.

About this study

This trial is a single-arm, open-label, phase I/II clinical study of LBL-024 in patients with advanced malignant tumors. The phase I dose escalation and PK expansion phase plans to include patients with advanced malignant tumors who have failed previous standard treatment or do not have standard treatment or are not applicable to standard treatment at this stage. The phase IIa indication expansion phase plans to include patients with advanced malignant tumors , and evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, immunogenicity and preliminary efficacy. Single-arm registry clinical study to be conducted in Phase IIb.

This trial includes two parts:

Part I: A Phase I/IIa clinical study on the safety, tolerability, PK and efficacy of LBL-024 in patients with advanced malignant tumor.

Part II:Phase IIb is a pivotal single-arm clinical study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

LBL-024 for Injection

Drug

LBL-024 was given every three weeks for treatment

Other names: LBL-024

Primary outcomes

  1. Maximum tolerated dose (MTD)

    Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）

    During the dose-escalation phase, the highest dose of dose-limiting toxicity for subjects less than or equal to 1/6 of the study drug within 3 weeks of starting treatment in Phase I study.

  2. Dose-limiting toxicities（DLT)

    Time frame: Within 3 weeks after receiving the first dose of the test drug

    During the DLT observation period, the subject has an event that is reasonably related to the test drug (possibly, likely or definitely related) in Phase I study.

  3. Objective Response Rate (ORR)

    Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）

    Defined as the percentage of subjects having a Complete Response or Partial Response(ORR, including after immunotherapy complete response (iCR) and partial response (iPR)),will be determined by investigator assessment of radiographic disease assessments per RECIST V1.1. It was used to evaluate the efficacy of LBL-024 in Phase II study.

Secondary outcomes

  1. Adverse events and serious adverse events

    Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）

    Laboratory examination, physical examination, vital signs and electrocardiogram, etc.

  2. Maximum serum concentration (Cmax)

    Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）

    To determine the PK profile of LBL-024

  3. Immunogenicity

    Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）

    Incidence of subjects with anti-drug antibody (ADA) and neutralizing antibody (if applicable)

  4. Disease Control Rate(DCR)

    Time frame: Visit 30 days after discontinuation of treatment or withdraw from the visit

    Defined as percentage of participants having CR, PR, iCR，iPR or SD as best on-study response

  5. Progression-free survival (PFS)

    Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal（Visit 30 days after discontinuation of treatment or withdraw from the visit）

    Defined as the time from random assignment in a clinical trial to disease progression or death from any cause, has recently become an endpoint of considerable interest in the study of new oncology drugs.

Study contacts

Contact information is provided by the study sponsor or research team.

xue kong

CONTACT

[email protected]

025-83378099

Sponsors and collaborators

Lead sponsor

Nanjing Leads Biolabs Co.,Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 28, 2021
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.