A Phase Ib/II Clinical Trial of LBL-007 Combined With Tislelizumab in the Treatment of Malignant Tumors

Malignant Tumors Clinical Trial

Official title:

A Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LBL-007 in Combination With Tislelizumab in the Treatment of Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05516914
• Other study ID #: LBL-007-CN-004
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Nanjing Leads Biolabs Co.,Ltd
• Contact: Dongtao Meng
• Phone: 02583378099
• Email: mengdongtao[@]leadsbiolabs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is an open and multicenter phase Ib/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.

Description:

This is an open, multicenter Phase Ib/II clinical trial of LBL-007 combined with Tislelizumab in the treatment of malignant tumors，which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness. The study was divided into two phases: Phase Ib (Part A): Dose escalation and PK expansion; Phase II includes: Part B, Part C, Part D, Part E, Part F, Part G, Part H. Part B ~ Part H will be designed and conducted based on the safety , tolerability and PK analysis of the Part A Study Part, after RP2D is determined, will be used for Part B ~ Part H cohort. Approximately 250-490 subjects will be enrolled (Specific sample size shall be subject to actual occurrence)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 490
• Est. completion date: June 30, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

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

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

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

5. According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), the subjects enrolled have at least one measurable tumor lesion;

6. Subject has adequate organ and bone marrow function

7. Males with fertility and females of childbearing age are willing to take effective contraceptive measures (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception from the signing of the informed consent form to 6 months after the last administration of the trial drug 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 research drugs or treatments within 4 weeks before using the research drug for the first time;

2. Those who have clinically uncontrollable pleural effusion, pericardial effusion or ascites, requiring repeated drainage or medical intervention;

3. Women during pregnancy or lactation;

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

5. Patients with history of severe cardiovascular and cerebrovascular diseases.

6. Patients with active infection and currently requiring intravenous anti-infective treatment

Related Conditions & MeSH terms

• Malignant Tumors
• Neoplasms

Intervention

Drug:
• LBL-007 Injection
Initial dose - MTD; Q3W; intravenous infusion
• Tislelizumab Injection
Initial dose; Q3W; intravenous infusion
• Cisplatin Injection
Initial dose;Q3W; intravenous infusion
• Gemcitabine Hydrochloride for Injection
Initial dose;Q3W; intravenous infusion
• Docetaxel injection
Initial dose;Q3W; intravenous infusion

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Hainan Medical University	Haikou	Hainan
China	Zhejiang Cancer Hospital	Hangzhou	Hangzhou
China	Anhui Cancer Hospital	Hefei	Anhui
China	Huizhou Municipal Central Hospital	Huizhou	Guangdong
China	The Jiangmen Central Hospital	Jiangmen	Guangdong
China	Maoming People's Hospital	Maoming	Guangdong
China	Jiangxi Cancer Hospital	Nanchang	Jiangxi
China	Guangxi Tumour Hospital	Nanning	Guangxi
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Union Hospital Tongji Medical College Huazhong University of Science And Technology	Wuhan	Hubei
China	The First People's Hospital of Yu Lin	Yulin	Guangxi
China	Central People's Hospital of Zhanjinag	Zhanjiang	Guangdong

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	Objective Response Rate (ORR)	ORR (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST), refers to the percentage of study subjects who achieve a complete response or partial response	All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy
Primary	Dose-limiting toxicities(DLT)	DLT is defined as toxicity during the DLT observation period (3 weeks after the first dose).	DLT is defined as toxicity during the DLT observation period. The duration of DLT observation period is from the first dose to 3 weeks after the first dose
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	At the end of Cycle 1 (each cycle is 21days)
Secondary	Cmax	Maximum serum concentration	All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 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	All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy)
Secondary	Disease Control Rate(DCR)	DCR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD).	All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy)
Secondary	Duration of Response(DOR)	To measure duration of response	All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 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	All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy)