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

NCT05516914 | Completed Phase 1 DMC

• 1 other identifier: LBL-007-CN-004
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Malignant Tumors

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Cmax

  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)

• immunogenicity

  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)

• Disease Control Rate(DCR)

  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)

• Duration of Response(DOR)

  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)

• Tmax

  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)

Study Arms (1)

LBL-007 & Tislelizumab

EXPERIMENTAL

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

Drug: LBL-007 Injection; Drug: Tislelizumab Injection; Drug: Cisplatin Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Docetaxel injection

Interventions

LBL-007 Injection DRUG

Initial dose - MTD; Q3W; intravenous infusion

Also known as: LBL-007

LBL-007 & Tislelizumab

Tislelizumab Injection DRUG

Initial dose; Q3W; intravenous infusion

Also known as: Tislelizumab

LBL-007 & Tislelizumab

Cisplatin Injection DRUG

Initial dose；Q3W; intravenous infusion

Also known as: Cisplatin

LBL-007 & Tislelizumab

Gemcitabine Hydrochloride for Injection DRUG

Initial dose；Q3W; intravenous infusion

Also known as: Gemcitabine Hydrochloride

LBL-007 & Tislelizumab

Docetaxel injection DRUG

Initial dose；Q3W; intravenous infusion

Also known as: Docetaxel

LBL-007 & Tislelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agree to follow the experimental treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form;
• Age ≥ 18 and ≤ 75 years old when signing the informed consent form, regardless of gender;
• The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) PS is 0\~1;
• The expected survival time is at least 12 weeks;
• According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), the subjects enrolled have at least one measurable tumor lesion;
• Subject has adequate organ and bone marrow function
• 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.

You may not qualify if:

• Have received other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;
• Those who have clinically uncontrollable pleural effusion, pericardial effusion or ascites, requiring repeated drainage or medical intervention;
• Women during pregnancy or lactation;
• The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
• Patients with history of severe cardiovascular and cerebrovascular diseases.
• Patients with active infection and currently requiring intravenous anti-infective treatment

Sponsors & Collaborators

• Nanjing Leads Biolabs Co.,Ltd: lead

Study Sites (15)

Anhui Cancer Hospital

Hefei, Anhui, 230031, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, 350001, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Sun Yat-Sen Memorial Hospital，Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

Location

Huizhou Municipal Central Hospital

Huizhou, Guangdong, 516000, China

Location

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530000, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

The First People's Hospital of Yu Lin

Yulin, Guangxi, 537000, China

Location

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, 570000, China

Location

Zhejiang Cancer Hospital

Hangzhou, Hangzhou, 310000, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430000, China

Location

Union Hospital Tongji Medical College Huazhong University of Science And Technology

Wuhan, Hubei, 430022, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410000, China

Location

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Neoplasms

Interventions

tislelizumab; Cisplatin; Gemcitabine; Injections; Docetaxel

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Drug Administration Routes; Drug Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• li zhang

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 26, 2022
• Study Start: September 1, 2022
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)