Advanced Malignant Tumors
Conditions
Brief summary
This trial is an open and multicenter phase I/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.
Detailed description
This is an open, multicenter Phase I/II clinical trial of LBL-033 in the treatment of patients with advanced malignant tumors，which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness. The trial is divided into 2 parts: Phase 1 and Phase 2 Phase I study: Dose-escalation and PK expansion.The PK expansion study will be judged on the basis of dose escalation data. Phase II study: Dose expansion included 4 cohorts that required patients with MUC16-positive malignancies.Blood samples will be collected from all subjects in this trial. Phase I and Phase II studies are expected to recruit 113-468 patients
Interventions
DRUGLBL-033 for Injection
Initial dose - MTD; Q2W; intravenous infusion
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 No maximum
Healthy volunteers
No
Inclusion criteria
1. Agree to follow the experimental treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form; 2. Age ≥ 18 years old when signing the informed consent form; 3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1; 4. The expected survival time is at least 12 weeks; 5. According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable Target lesion; 6. Subject has adequate organ and bone marrow function，Conforming to laboratory test results: 7. 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. Have received other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time; 2. Patients with active infection and currently requiring intravenous anti-infective treatment； 3. Those who have clinically uncontrollable pleural effusion, pericardial effusion , requiring repeated drainage or medical intervention; 4. The patient has a Medical history of immunodeficiency, including HIV antibody positive； 5. Women during pregnancy or lactation; 6. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicities（DLT） | At the end of Cycle 1（28 days after the first prespecified dose） | DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. |
| Maximum tolerated dose (MTD) | At the end of Cycle 1（28 days after the first prespecified dose） | MTD is defined as the hightest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycles |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy | Maximum serum concentration |
| Tmax | From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy | After taking a single dose, Time to reach maximum plasma concentration |
| immunogenicity | From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy | The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects |
| Disease Control Rate(DCR） | From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy | Percentage of participants achieving CR and PR and stable disease (SD). |
| Duration of Response(DOR） | From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy | The period from the participants first achieving CR or PR to disease progression. |
| Objective Response Rate (ORR) | From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy. | Objective Response Rate (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1), refers to the percentage of study subjects who achieve a complete response or partial response. This Secondary Outcome Measure was used for efficacy observations in Phase I study |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORjihong liu
Sun Yat-Sen University Cancer Center
Outcome results
None listed