Clinical trial NCT05042908: Evaluation of LBL-003 Phase I Study in Patients With Advanced Malignancies
Official title: Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-003 Injection in Patients With Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Malignant Tumor
Keywords: Advanced Malignant Tumor
Lead sponsor: Nanjing Leads Biolabs Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Henan Cancer Hospital
name: Hunan Cancer Hospital
name: Shandong Cancer Hospital and Institute
First posted: 2021-09-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Both male and female aged 18-75 years (including borderline values) at the time of signing the informed consent form;
2. ECOG score: 0-1;
3. Agree to follow the study treatment plan and visit plan, voluntarily enrolls, and signs the written informed consent.
4. 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.
5. Subjects should have at least one evaluable lesion as defined by RECIST V1.1;
6. Subjects are expected to survive at least 12 weeks;

Exclusion Criteria:

1. History of immunodeficiency, including positive HIV antibody test results；
2. Active hepatitis (hepatitis B or C)；
3. having undergone major surgery or still in the recovery phase of an earlier surgery within 4 weeks before the first administration;
4. Women during pregnancy or lactation;
5. 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.

Primary outcomes:
measure: Maximum tolerated dose (MTD)
timeFrame: Within 4 weeks after receiving the first dose of the test drug
measure: Dose-limiting toxicities（DLT）
timeFrame: Within 4 weeks after receiving the first dose of the test drug
Secondary outcomes:
measure: Number of subjcects with adverse events and serious adverse events
timeFrame: 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
measure: Cmax
timeFrame: 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
measure: Tmax
timeFrame: 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
measure: immunogenicity
timeFrame: 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
measure: Objective Response Rate (ORR)
timeFrame: 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).
measure: Pharmacodynamic (PD) index
timeFrame: 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
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Jinan
country: China
facility: Shangdong Cancer Hospital
state: Shandong
Study officials:
affiliation: Henan Cancer Hospital
name: Suxia Luo
role: PRINCIPAL_INVESTIGATOR
References: