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

Advanced Malignant Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05042908
• Other study ID #: LBL-003-CN-001
• Status: Completed
• Phase: Phase 1
• Start date: December 2, 2021
• Est. completion date: April 10, 2023

Study information

• Verified date: May 2024
• Source: Nanjing Leads Biolabs Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 10, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Malignant Tumor
• Neoplasms

Intervention

Drug:
• LBL-003 Injection
LBL-003 was given every two weeks for treatment

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan
China	Shangdong Cancer Hospital	Jinan	Shandong
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (4)

Lead Sponsor	Collaborator
Nanjing Leads Biolabs Co.,Ltd	Henan Cancer Hospital, Hunan Cancer Hospital, Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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).
Secondary	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