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

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.

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.

Study Overview

• Status: Completed
• Conditions: Advanced Malignant Tumor
• Intervention / Treatment: Drug: LBL-015 for Injections

Detailed Description

This study is a single-arm, open-label, multi-center, dose-escalation and expansion phase I/II study to evaluate the safety, tolerability, pharmacokinetic characteristics, receptor occupancy, immunogenicity and efficacy of LBL-015 in patients with advanced malignant tumors.About 202 patients with advanced malignant tumor will be enrolled.

The study is divided into Phase I study stage (dose escalation/PK expansion stage) and Phase II study stage (indication expansion stage).

Patients with advanced or metastatic advanced malignant tumor who have failed previous standard treatment, are not suitable for standard treatment or have no standard treatment are included in the phase I study.

After obtaining the RP2D in Phase I study ,Phase II study stage (indication expansion stage) was initiated.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233000
      • The First Affiliated Hospital Of Bengbu Medical College
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Henan Cancer Hospital
  • Hunan
    • Changsha, Hunan, China, 410031
      • Hunan Cancer Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • The First Affiliated Hospital of Nanchang University
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200123
      • Shanghai East Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Agree to follow the trial treatment regimen and visit schedule, voluntarily enroll in the study, and sign the written informed consent form；
2. Age ≥18 and ≤75 years old at the time of signing the informed consent form, regardless of gender;
3. Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale；
4. Have a life expectancy of at least 12 weeks；
5. There is adequate organ and bone marrow function,Conforms to laboratory test results;
6. 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.

Exclusion Criteria:

1. Received other unapproved investigational drug or treatment within 4 weeks prior to first dose of investigational drug；
2. 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；
3. 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；
4. Subjects with an active infection that currently requires intravenous anti infective therapy；
5. History of immunodeficiency, including positive HIV antibody test results；
6. Pregnant or lactating women；
7. 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-015; Drug: LBL-015 for Injection，Initial dose - MTD; Q2W	Drug: LBL-015 for Injections; Initial dose - MTD ; Q2W ; intravenous infusion; Other Names: LBL-015

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. 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 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
Pharmacodynamic (PD) index	Evaluate the receptor occupancy of the drug	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: The First Affiliated Hospital of Nanchang University; Henan Cancer Hospital; Hunan Cancer Hospital; Shandong Cancer Hospital and Institute; Shanghai East Hospital; First Affiliated Hospital Bengbu Medical College
• Investigators: Principal Investigator: Jin Li, Shanghai East Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2021
• Primary Completion (Actual): December 5, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: LBL-015-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