Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-003 Injection in Patients With Advanced Malignancies
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 18
- Locations
- 3
- Primary Endpoint
- Maximum tolerated dose (MTD)
Study Overview
Brief Summary
This study is a single-arm, dose-escalation phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of LBL-003 injection in patients with advanced malignant tumors.
Detailed Description
The purpose of the single-dose escalation study of LBL-003 in subjects with advanced malignant tumors was to evaluate the safety and tolerability of monotherapy to determine the MTD (or MAD) and to determine the clinically recommended dose of LBL-003 monotherapy.
All subjects in this study underwent pharmacokinetic (PK) and pharmacodynamic (PD) studies. The dosing frequency of LBL-003 is once every 2 weeks (Q2W), and the subsequent dosing frequency is adjusted according to the obtained PK and tolerability results.
This study is expected to enroll 17-36 patients with solid tumors who have no standard treatment or have treatment failure with standard treatment or are not suitable for standard treatment at this stage.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Both male and female aged 18-75 years (including borderline values) at the time of signing the informed consent form;
- •ECOG score: 0-1;
- •Agree to follow the study treatment plan and visit plan, voluntarily enrolls, and signs the written informed consent.
- •Subjects with advanced malignant solid tumors confirmed by histology or cytology have failed the standard treatment or have no standard treatment protocol or are not suitable for standard treatment at this stage.
- •Subjects should have at least one evaluable lesion as defined by RECIST V1.1;
- •Subjects are expected to survive at least 12 weeks;
Exclusion Criteria
- •History of immunodeficiency, including positive HIV antibody test results；
- •Active hepatitis (hepatitis B or C)；
- •having undergone major surgery or still in the recovery phase of an earlier surgery within 4 weeks before the first administration;
- •Women during pregnancy or lactation;
- •The investigator's assessment that there may be other factors affecting compliance among participants or that some may not be suitable for inclusion in this study.
Arms & Interventions
LBL-003
Drug: LBL-003 injection ; Initial dose - MTD; Q2W
Intervention: LBL-003 Injection (Drug)
Outcomes
Primary Outcomes
Maximum tolerated dose (MTD)
Time Frame: Within 4 weeks after receiving the first dose of the test drug
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.
Dose-limiting toxicities（DLT）
Time Frame: Within 4 weeks after receiving the first dose of the test drug
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. It was used to evaluate the safety.
Secondary Outcomes
- 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)
- Pharmacodynamic (PD) index(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)
- 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)
- Number of subjcects with adverse events and serious adverse events(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)
- 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).)