Clinical trial NCT05107011: Phase I/II Clinical Trial of LBL-015 for Injection
Official title: A Multicenter, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of LBL-015 in Patients With Advanced Malignant Tumors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Malignant Tumor
Lead sponsor: Nanjing Leads Biolabs Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Shanghai East Hospital
name: Shandong Cancer Hospital and Institute
name: Henan Cancer Hospital
name: Hunan Cancer Hospital
name: The First Affiliated Hospital of Nanchang University
name: The First Affiliated Hospital of Bengbu Medical University
First posted: 2021-11-04
Enrollment: 25
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: A Multicenter, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of LBL-015 in Patients With Advanced Malignant Tumors.

Detailed description: This study is a single-arm, open-label, multi-center, dose-escalation and expansion phase I/II study to evaluate the safety, tolerability, pharmacokinetic characteristics, receptor occupancy, immunogenicity and efficacy of LBL-015 in patients with advanced malignant tumors.About 202 patients with advanced malignant tumor will be enrolled.

The study is divided into Phase I study stage (dose escalation/PK expansion stage) and Phase II study stage (indication expansion stage).

Patients with advanced or metastatic advanced malignant tumor who have failed previous standard treatment, are not suitable for standard treatment or have no standard treatment are included in the phase I study.

After obtaining the RP2D in Phase I study ,Phase II study stage (indication expansion stage) was initiated.

Eligibility criteria: Inclusion Criteria:

1. Agree to follow the trial treatment regimen and visit schedule, voluntarily enroll in the study, and sign the written informed consent form；
2. Age ≥18 and ≤75 years old at the time of signing the informed consent form, regardless of gender;
3. Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale；
4. Have a life expectancy of at least 12 weeks；
5. There is adequate organ and bone marrow function,Conforms to laboratory test results;
6. Fertile men and women of childbearing age are willing to take effective contraceptive measures (including abstinence, intrauterine devices, hormonal contraception, and correct use of condoms) from the signing of the informed consent form to 6 months after the last dose of the investigational drug; women of childbearing age include premenopausal women and women who had menopause less than two years ago. Blood pregnancy test results must be negative for women of childbearing age within 7 days prior to the initial dose of the investigational drug.

Exclusion Criteria:

1. Received other unapproved investigational drug or treatment within 4 weeks prior to first dose of investigational drug；
2. Subjects who underwent major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the initial use of the investigational drug, or require elective surgery during the trial period；
3. Use of immunomodulatory drugs within 14 days prior to the initial use of the investigational drug, including but not limited to thymosin, interleukin, and interferon；
4. Subjects with an active infection that currently requires intravenous anti infective therapy；
5. History of immunodeficiency, including positive HIV antibody test results；
6. Pregnant or lactating women；
7. 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: 28 days after the first dose.
measure: Dose-limiting toxicities（DLT）
timeFrame: 28 days after the first dose
Secondary outcomes:
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: 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: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
Study officials:
affiliation: Shanghai East Hospital
name: Jin li
role: PRINCIPAL_INVESTIGATOR
References: