Evaluation of LBL-003 Phase I Study in Patients With Advanced Malignancies

NCT05042908 | Completed Phase 1

• 1 other identifier: LBL-003-CN-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

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.

Conditions

Advanced Malignant Tumor

Keywords

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.

  Within 4 weeks after receiving the first dose of the test drug

• 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.

  Within 4 weeks after receiving the first dose of the test drug

Secondary Outcomes (6)

• Number of subjcects with adverse events and serious adverse events

  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

• 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

• Objective Response Rate (ORR)

  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-003

EXPERIMENTAL

Drug: LBL-003 injection ; Initial dose - MTD; Q2W

Drug: LBL-003 Injection

Interventions

LBL-003 Injection DRUG

LBL-003 was given every two weeks for treatment

Also known as: LBL-003

LBL-003

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nanjing Leads Biolabs Co.,Ltd: lead
• Henan Cancer Hospital: collaborator
• Hunan Cancer Hospital: collaborator
• Shandong Cancer Hospital and Institute: collaborator

Study Sites (3)

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410031, China

Location

Shangdong Cancer Hospital

Jinan, Shandong, 250117, China

Location

Study Officials

• Suxia Luo

  Henan Cancer 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: September 3, 2021
• First Posted: September 13, 2021
• Study Start: December 2, 2021
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)