Advanced Solid Tumor
Conditions
Brief summary
To evaluate the phase I/II clinical study of LBL-024 in the treatment of patients with advanced malignant tumors
Detailed description
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.
Interventions
LBL-024 was given every three weeks for treatment
Sponsors
Nanjing Leads Biolabs Co.,Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose (MTD) | 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. |
| Dose-limiting toxicities（DLT) | 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. |
| Objective Response Rate (ORR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate(DCR) | 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 |
| Adverse events and serious adverse events | 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. |
| Progression-free survival (PFS) | 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. |
| Maximum serum concentration (Cmax) | 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 |
| Immunogenicity | 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) |
Countries
China
Contacts
Primary Contactxiangyu ma
Outcome results
None listed