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

Advanced Solid Tumor Clinical Trial

Official title:

An Open-label, Multi-center, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti Tumor Activity of LBL-015 in Patients With Advanced Malignant Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05107011
• Other study ID #: LBL-015-CN-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 5, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Nanjing Leads Biolabs Co.,Ltd
• Contact: jingning song
• Phone: 025-83378099-842
• Email: songjingning[@]leadsbiolabs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase I/II clinical study evaluating LBL-015 in the treatment of subjects with advanced solid tumors

Description:

This trial is a single-arm, open, multi-center, dose-escalation and extended phase I/II study, aiming to evaluate the safety, tolerability, pharmacokinetic characteristics, and receptor occupancy of LBL-015 in patients with advanced malignant tumors Rate (RO), immunogenicity and effectiveness. Approximately 202 subjects with advanced malignant tumors are planned to be included. The study is divided into two phases: Phase I (dose escalation/PK expansion phase) and Phase II (indication expansion phase)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 202
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Agree to follow the trial treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form;

2. Age =18 and =75 years old at the time of signing the informed consent form, regardless of gender;

3. Eastern Cooperative Oncology Group performance status scoring criteria (ECOG) PS of 0 ~ 1 points (see Appendix 1 for criteria);

Exclusion Criteria:

1. Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before using the study

drug for the first time, except for the following items:

2. Have received other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;

3. Patients who have previously received treatment with PD-1/PD-L1 and TGF-ß bifunctional antibody drugs or received treatment with PD-1/PD-L1 combined with TGF-ß target drugs;

4. Patients who have undergone major organ surgery (excluding needle biopsy) or have significant trauma within 4 weeks before using the study drug for the first time,or required elective surgery during the trial period;

5. Use of immunomodulatory drugs within 14 days before the first use of study drugs, including but not limited to thymosin, interleukin-2, interferon, etc.;

Related Conditions & MeSH terms

• Advanced Solid Tumor

Intervention

Drug:
• LBL-015 for Injections
LBL-015 was given every two weeks for treatment

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Hunan Cancer Hospital	Changsha	Hunan
China	Shandong Cancer Hospital	Jinan	Shandong
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Shanghai Oriental Hospital	Shanghai	Shanghai
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Leads Biolabs Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD)	During the dose-escalation phase, the highest dose of dose-limiting toxicity for subjects less than or equal to 1/6 of the study drug within 4 weeks of starting treatment	28 days after the first dose
Primary	Dose-limiting toxicities(DLT)	During the DLT observation period, the subject has an event that is reasonably related to the test drug (possibly, likely or definitely related)	28 days after the first dose