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

Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-003 Injection in Patients With Advanced Malignancies

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.

Study Overview

• Status: Completed
• Conditions: Advanced Malignant Tumor
• Intervention / Treatment: Drug: LBL-003 Injection

Detailed Description

The purpose of the single-dose escalation study of LBL-003 in subjects with advanced malignant tumors was to evaluate the safety and tolerability of monotherapy to determine the MTD (or MAD) and to determine the clinically recommended dose of LBL-003 monotherapy.

All subjects in this study underwent pharmacokinetic (PK) and pharmacodynamic (PD) studies. The dosing frequency of LBL-003 is once every 2 weeks (Q2W), and the subsequent dosing frequency is adjusted according to the obtained PK and tolerability results.

This study is expected to enroll 17-36 patients with solid tumors who have no standard treatment or have treatment failure with standard treatment or are not suitable for standard treatment at this stage.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Henan Cancer Hospital
  • Hunan
    • Changsha, Hunan, China, 410031
      • Hunan Cancer Hospital
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shangdong Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Both male and female aged 18-75 years (including borderline values) at the time of signing the informed consent form;
2. ECOG score: 0-1;
3. Agree to follow the study treatment plan and visit plan, voluntarily enrolls, and signs the written informed consent.
4. 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.
5. Subjects should have at least one evaluable lesion as defined by RECIST V1.1;
6. Subjects are expected to survive at least 12 weeks;

Exclusion Criteria:

1. History of immunodeficiency, including positive HIV antibody test results；
2. Active hepatitis (hepatitis B or C)；
3. having undergone major surgery or still in the recovery phase of an earlier surgery within 4 weeks before the first administration;
4. Women during pregnancy or lactation;
5. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LBL-003; Drug: LBL-003 injection ; Initial dose - MTD; Q2W	Drug: LBL-003 Injection; LBL-003 was given every two weeks for treatment; Other Names: LBL-003

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum serum concentration	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	After taking a single dose, Time to reach maximum plasma concentration	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	The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects	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
Number of subjcects with adverse events and serious adverse events	The safety profile of LBL-003 will be assessed by monitoring the adverse event(AE)	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)	ORR (including the rates of complete response (CR) and partial response (PR)), evaluated based on the RECIST 1.1, refers to the percentage of study subjects who achieve a complete response or partial response.	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	The evaluation index is receptor occupancy rate in peripheral blood	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

Collaborators and Investigators

• Sponsor: Nanjing Leads Biolabs Co.,Ltd
• Collaborators: Henan Cancer Hospital; Hunan Cancer Hospital; Shandong Cancer Hospital and Institute
• Investigators: Principal Investigator: Suxia Luo, Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2021
• Primary Completion (Actual): April 10, 2023
• Study Completion (Actual): April 10, 2023

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Advanced Malignant Tumor
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: LBL-003-CN-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No