Clinical trial NCT05223231: Evaluation of LBL-019 Monotherapy or Combined With Anti-PD-1 Antibody in the Treatment of Advanced Malignant Tumors
Official title: A Multicenter, Open Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LBL-019 Monotherapy or Combination Anti-PD-1 Antibody in Patients With Advanced Malignant Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Malignant Tumors
Lead sponsor: Nanjing Leads Biolabs Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2022-02-03
Enrollment: 486
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 trial is a phase I/II study, which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (RO), immunogenicity and effectiveness of LBL-019 monotherapy or combined with anti-PD-1 antibody in patients with advanced malignant tumors.

Detailed description: This trial is a phase I/II study , which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (RO), immunogenicity and effectiveness of LBL-019 monotherapy or combined with anti-PD-1 antibody in patients with advanced malignant tumors. Approximately 244-486 subjects with advanced malignant tumors will be enrolled.

The study was divided into two phases: Phase I (Part A single therapy dose escalation and Part B combination therapy dose escalation) and Phase II (Part A single therapy dose expansion and Part B combination therapy dose expansion) .

Eligibility criteria: Inclusion Criteria:

1.Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form;

2.18-75 years old (including boundary value), no gender limit;

3. previous standard treatment failed, no standard treatment or standard treatment is not applicable at this stage;

4.The expected survival time is at least 12 weeks;

Exclusion Criteria:

1. Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before using the study drug for the first time；
2. Received any other investigational drug or treatment that is not on the market within 4 weeks prior to the initial use of the investigational drug;
3. Women who are pregnant or breastfeeding;
4. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study

Primary outcomes:
measure: safety and tolerability
timeFrame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
Secondary outcomes:
measure: Cmax
timeFrame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
measure: immunogenicity
timeFrame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
measure: Pharmacodynamics
timeFrame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
measure: ORR
timeFrame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
measure: DCR
timeFrame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
measure: DOR
timeFrame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Wuhan
country: China
facility: Union hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: The first affiliated hospital with Nanjing medical university
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: caicun zhou
role: PRINCIPAL_INVESTIGATOR
References: