To evaluate the phase I/II clinical study of LBL-024 in the treatment of patients with advanced malignant tumors
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
396
LBL-024 was given every three weeks for treatment
Maximum tolerated dose (MTD)
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.
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)
Dose-limiting toxicities(DLT)
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.
Time frame: Within 3 weeks after receiving the first dose of the test drug
Objective Response Rate (ORR)
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.
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)
Adverse events and serious adverse events
Laboratory examination, physical examination, vital signs and electrocardiogram, etc.
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)
Maximum serum concentration (Cmax)
To determine the PK profile of LBL-024
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)
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
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Hefei, Anhui, China
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Hefei, Anhui, China
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Beijing, Beijing Municipality, China
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Beijing, Beijing Municipality, China
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Chongqing, Chongqing Municipality, China
RECRUITINGFujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGFujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGThe First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
RECRUITING...and 39 more locations
Immunogenicity
Incidence of subjects with anti-drug antibody (ADA) and neutralizing antibody (if applicable)
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)
Disease Control Rate(DCR)
Defined as percentage of participants having CR, PR, iCR,iPR or SD as best on-study response
Time frame: Visit 30 days after discontinuation of treatment or withdraw from the visit
Progression-free survival (PFS)
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.
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)