Phase I/II Clinical Trial of LBL-015 for Injection

NCT05107011 | Completed Phase 1 DMC

• 1 other identifier: LBL-015-CN-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 6

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.

Conditions

Advanced Malignant Tumor

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD)

  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. It was used to evaluate the tolerability.

  28 days after the first dose.

• Dose-limiting toxicities（DLT）

  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.

  28 days after the first dose

Secondary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

LBL-015

EXPERIMENTAL

Drug: LBL-015 for Injection，Initial dose - MTD; Q2W

Drug: LBL-015 for Injections

Interventions

LBL-015 for Injections DRUG

Initial dose - MTD ; Q2W ; intravenous infusion

Also known as: LBL-015

LBL-015

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 follow the trial treatment regimen and visit schedule, voluntarily enroll in the study, and sign the written informed consent form；
• Age ≥18 and ≤75 years old at the time of signing the informed consent form, regardless of gender;
• Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale；
• Have a life expectancy of at least 12 weeks；
• There is adequate organ and bone marrow function,Conforms to laboratory test results;
• 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.

You may not qualify if:

• Received other unapproved investigational drug or treatment within 4 weeks prior to first dose of investigational drug；
• 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；
• 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；
• Subjects with an active infection that currently requires intravenous anti infective therapy；
• History of immunodeficiency, including positive HIV antibody test results；
• Pregnant or lactating women；

Sponsors & Collaborators

• Nanjing Leads Biolabs Co.,Ltd: lead
• Shanghai East Hospital: collaborator
• Shandong Cancer Hospital and Institute: collaborator
• Henan Cancer Hospital: collaborator
• Hunan Cancer Hospital: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• The First Affiliated Hospital of Bengbu Medical University: collaborator

Study Sites (6)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233000, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410031, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200123, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jin li

  Shanghai East Hospital

  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: October 20, 2021
• First Posted: November 4, 2021
• Study Start: November 8, 2021
• Primary Completion: December 5, 2023
• Study Completion: December 5, 2023
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)