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

Launched by NANJING LEADS BIOLABS CO.,LTD · Aug 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment that combines two medications, LBL-007 and Tislelizumab, for patients with malignant tumors, which are types of cancer. The main goal is to see how safe the treatment is and how well it works in helping patients. The trial is currently looking for participants aged 18 to 75 years who have at least one measurable tumor and are in good overall health, meaning they can carry out normal activities with minimal limitations. Participants need to agree to follow the treatment plan and have a positive outlook for at least 12 weeks.

If you join this trial, you can expect to receive regular check-ups and monitoring to ensure your safety and assess how the treatment is working. It's important to note that there are certain criteria that would exclude someone from participating, such as having serious heart conditions or being pregnant. Overall, this trial offers a chance to access a new treatment approach while helping researchers learn more about its effects on cancer.

Gender

ALL

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