Combining LBL-007 and Tislelizumab for treating malignant tumors

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

This study is testing if a new combination of two treatments, LBL-007 and Tislelizumab, can help people with malignant tumors feel better and improve their treatment outcomes.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 490 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Nanjing Leads Biolabs Co.,Ltd (Industry-sponsored)
• Drugs / interventions: Tislelizumab
• Locations: 19 sites (Hefei, Anhui and 18 other locations)
• Trial ID: NCT05516914 on ClinicalTrials.gov

What this trial studies

This open, multicenter Phase Ib/II clinical trial evaluates the safety, tolerability, pharmacokinetics, immunogenicity, and effectiveness of LBL-007 in combination with Tislelizumab for patients with malignant tumors. The study is divided into two phases: Phase Ib focuses on dose escalation and pharmacokinetic expansion, while Phase II will assess multiple cohorts based on the findings from Phase Ib. Approximately 250-490 subjects will be enrolled to determine the optimal treatment regimen and its effects on tumor response.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with measurable malignant tumors and adequate organ function.

Not a fit: Patients with severe comorbidities or those not meeting the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with malignant tumors.

How similar studies have performed: Other studies combining immunotherapy with targeted treatments have shown promising results, suggesting potential success for this approach.

Eligibility criteria

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

Where this trial is running

Hefei, Anhui and 18 other locations

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

Study contacts

• Principal investigator: li zhang — Sun Yat-sen University
• Study coordinator: Dongtao Meng

Conditions Malignant Tumors