NCT05779163CompletedPhase 1
A Multicenter, Open Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of LBL-033 in the Treatment of Patients With Advanced Malignant Tumors.
Nanjing Leads Biolabs Co.,Ltd6 sites in 1 country26 target enrollmentStarted: April 14, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 26
- Locations
- 6
- Primary Endpoint
- Dose-limiting toxicities（DLT）
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Agree to follow the experimental treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form;
- •Age ≥ 18 years old when signing the informed consent form;
- •The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1;
- •The expected survival time is at least 12 weeks;
- •According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable Target lesion;
- •Subject has adequate organ and bone marrow function，Conforming to laboratory test results:
- •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
- •Have received other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;
- •Patients with active infection and currently requiring intravenous anti-infective treatment；
- •Those who have clinically uncontrollable pleural effusion, pericardial effusion , requiring repeated drainage or medical intervention;
- •The patient has a Medical history of immunodeficiency, including HIV antibody positive；
- •Women during pregnancy or lactation;
- •The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
Arms & Interventions
LBL-033
Experimental
LBL-033 for Injection; Initial dose - MTD; Q2W
Intervention: LBL-033 for Injection (Drug)
Outcomes
Primary Outcomes
Dose-limiting toxicities（DLT）
Time Frame: 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)
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)
- 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.)
- 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)
- 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)
Investigators
Study Sites (6)
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