A Phase Ib/II Clinical Study of LBL-007 in Combination With Toripalimab in Treatment of Advanced Malignant Tumors

NCT ID: NCT05102006

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2024-05-22

Brief Summary

This is a single-arm, open-label, multicenter Phase Ib/II clinical study to evaluate the safety, tolerability, PK characteristics, immunogenicity and efficacy of LBL-007 in combination with Toripalimab in Treatment of Advanced Malignant Tumors.

Detailed Description

This trial is divided into combination dose escalation phase (Phase Ib) and combination dose expansion phase (Phase II), as follows:

1. In the Phase Ib study, patients with advanced neoplasm malignant who have no standard treatment or have treatment failure of standard treatment or are not suitable for standard treatment at present stage are planned to be enrolled,including patients with advanced neoplasm malignant who have not been treated with anti-PD- (L) 1 antibody or have progressed or not tolerated after treatment with anti-PD- (L) 1 antibody.LBL-007 is administered once every 3 weeks (Q3W),intravenous infusion.The dosing regimen of toripalimab in combination was once every 3 weeks (Q3W),Intravenous infusion.

2. According to the LBL-007 global research and development data and the safety, tolerability and PK data of the phase Ib clinical study, the recommended dose of phase II clinical study (RP2D) was obtained for the expansion of target indications.This study is designed to enroll patients with advanced neoplasm malignant, including patients who have not been treated with anti-PD- (L) 1 antibody or patients who have progressed or intolerant after treatment with anti-PD- (L) 1 antibody.Subjects need to undergo relevant examinations or observations during the screening period,and subjects who meet the screening requirements will enter the treatment period.

3. Biological samples will be collected from subjects in Phase Ib/II for relevant testing in this trial.Phase Ib is expected to enroll approximately 9-12 subjects.Phase II is expected to enroll approximately 200 subjects.The number of subjects to be enrolled was determined by actual conditions.

Conditions

Advanced Malignant Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LBL-007&Toripalimab

LBL-007 Injection; dose A or dose B; Q3W

Toripalimab Injection; dose C; Q3W

Group Type: EXPERIMENTAL

LBL-007 Injection

Intervention Type: DRUG

LBL-007 Injection; dose A or dose B; Q3W

Toripalimab Injection

Intervention Type: DRUG

Toripalimab Injection; dose C; Q3W

Interventions

LBL-007 Injection

LBL-007 Injection; dose A or dose B; Q3W

Intervention Type: DRUG

Toripalimab Injection

Toripalimab Injection; dose C; Q3W

Intervention Type: DRUG

Other Intervention Names

LBL-007; Toripalimab

Eligibility Criteria

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 at the time of signing the informed consent, regardless of gender.

3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1.

4. The expected survival time is at least 12 weeks.

5. Males with fertility and females of childbearing age are willing to take highly effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception Sets，etc）;Women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.

Exclusion Criteria

1. Have received other unmarketed clinical investigational drugs or treatments within 4 weeks prior to the first dose of study drug.

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

3. Patients with active infection and currently requiring intravenous anti-infective therapy.

4. Patients with clinically uncontrollable pleural effusion, pericardial effusion or ascites, and those requiring repeated drainage or medical intervention.

5. The patient has a Medical history of immunodeficiency, including HIV antibody positive.

6. Active hepatitis B or active hepatitis C.

7. Women during pregnancy or lactation.

8. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Leads Biolabs Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

li zhang

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

The first affiliated hospital of bengbu medical University

Bengbu, Anhui, China

Chongqing University Three gorges Hospital

Chongqing, Chongqing Municipality, China

The 900 Hospital of the Joint Service Support Force of the People's Liberation Army of China

Fuzhou, Fujian, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

The First People's Hospital of Yu Lin

Yulin, Guangxi, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Changzhou Cancer Hospital

Changzhou, Jiangsu, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Affiliated Hospital of Jining Medical University

Jining, Shandong, China

Linyi Cancer Hospital

Linyi, Shandong, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

LBL-007-CN-003

Identifier Type: -

Identifier Source: org_study_id