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

NCT05170958
clinicaltrials.gov
Phase
Phase 1/Phase 2
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
396
clinicaltrials.gov
Lead sponsor
Nanjing Leads Biolabs Co.,Ltd
clinicaltrials.gov
Start date
2022-01-06
clinicaltrials.gov
Number of sites
49
clinicaltrials.gov

Summary
To evaluate the phase I/II clinical study of LBL-024 in the treatment of patients with advanced malignant tumors
clinicaltrials.gov
Short title
A Phase I/II Clinical Study of LBL-024 in Patients With Advanced Malignant Tumors
clinicaltrials.gov
Official 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
clinicaltrials.gov

Control arm
Open label
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 1/Phase 2
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2026-12-01
clinicaltrials.gov
First posted
2021-12-28
clinicaltrials.gov
Registry last updated
2026-06-30
clinicaltrials.gov
Primary completion date
2026-12-01
clinicaltrials.gov
Start date
2022-01-06
clinicaltrials.gov

Participants
396
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
396
clinicaltrials.gov
Protocol amendments
3
clinicaltrials.gov
Number of sites
49
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Nanjing Leads Biolabs Co.,Ltd
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05170958
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05170958
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Maximum tolerated dose (MTD)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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.

  1. Adverse events and serious adverse events

    Timeframe: 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)

    Timeframe: 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

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No

  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.

  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
Sources for eligibility
clinicaltrials.gov

  • The First Affiliated Hospital of Anhui Medical UniversityHefei, ChinaRecruiting
  • Anhui Provincial HospitalHefei, ChinaRecruiting
  • The Second Hospital of Anhui Medical UniversityHefei, ChinaRecruiting
  • Peking Union Medical College HospitalBeijing, ChinaRecruiting
  • Cancer Hospital Chinese Academy of Medical SciencesBeijing, ChinaRecruiting
  • Beijing Cancer HospitalBeijing, ChinaRecruiting
  • Chongqing Cancer HospitalChongqing, ChinaRecruiting
  • Fujian Cancer HospitalFuzhou, ChinaRecruiting
  • Fujian Medical University Union HospitalFuzhou, ChinaRecruiting
  • The First Affiliated Hospital of Xiamen UniversityXiamen, ChinaRecruiting
  • The First Affiliated Hospital,Sun Yat-sen UniversityGuangzhou, ChinaRecruiting
  • Sun Yat-sen University Cancer CenterGuanzhou, ChinaRecruiting
  • Guangxi Medical University Cancer Hospital & Guangxi Cancer InstituteNanning, ChinaRecruiting
  • Affiliated Hospital of Zunyi Medical UniversityZunyi, ChinaRecruiting
  • Sir Run Run Shaw HospitalHangzhou, ChinaRecruiting
  • Fourth Hospital of Hebei Medical UniversityShijiazhuang, ChinaRecruiting
  • Harbin Medical University Cancer HospitalHarbin, ChinaRecruiting
  • Anyang Tumor HospitalAnyang, ChinaRecruiting
  • The First Affilated Hospital of Henan University of Science & TechnologyLuoyang, ChinaRecruiting
  • Henan Cancer HospitalZhengzhou, ChinaRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaRecruiting
  • Henan Provincial People's HospitalZhengzhou, ChinaRecruiting
  • Tongji HospitalWuhan, ChinaRecruiting
  • Wuhan Union Hospital of ChinaWuhan, ChinaRecruiting
  • Hubei Cancer HospitalWuhan, ChinaRecruiting

And 24 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)