Evaluation of LBL-019 Monotherapy or Combined With Anti-PD-1 Antibody in the Treatment of Advanced Malignant Tumors

NCT05223231 | Completed Phase 1 DMC

• 1 other identifier: LBL-019-CN001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 6

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.

Conditions

Advanced Malignant Tumors

Outcome Measures

Primary Outcomes (1)

• safety and tolerability

  To evaluate the safety, tolerability of LBL-019 monotherapy or combined with anti-PD-1 antibody, which is according to the number of DLT and the number of treatment related AES

  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 (6)

• Cmax

  All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months

• immunogenicity

  All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months

• Pharmacodynamics

  All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months

• ORR

  All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months

• DCR

  All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months

Study Arms (1)

LBL-019

EXPERIMENTAL

singal -arm

Drug: LBL-019 Injection; Drug: anti-PD-1 antibody injection

Interventions

LBL-019 Injection DRUG

initial dose-MTD

Also known as: LBL-019

LBL-019

anti-PD-1 antibody injection DRUG

provide medicine base on needs

Also known as: anti-PD-1 antibody

LBL-019

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form;
• years old (including boundary value), no gender limit;
• \. previous standard treatment failed, no standard treatment or standard treatment is not applicable at this stage;
• The expected survival time is at least 12 weeks;

You may not qualify if:

• 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；
• 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;
• Women who are pregnant or breastfeeding;
• The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study

Sponsors & Collaborators

• Nanjing Leads Biolabs Co.,Ltd: lead

Study Sites (6)

Fujian Cancer Hospital

Fuzhou, Fujian, 350000, China

Location

Union hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410006, China

Location

The first affiliated hospital with Nanjing medical university

Nanjing, Jiangsu, 210000, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Interventions

spartalizumab

Study Officials

• caicun zhou

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 3, 2022
• Study Start: April 19, 2022
• Primary Completion: August 9, 2024
• Study Completion: August 9, 2024
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

CN (6)