For Healthcare Professionals

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

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About the study

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

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION 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

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
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 02583378099Email iconEmail Study Center

Study Details


Contition

Malignant Tumors

Age

18+

Phase

PHASE1/PHASE2

Participants Needed

490

Est. Completion Date

Jun 30, 2025

Treatment Type

INTERVENTIONAL


Sponsor

Nanjing Leads Biolabs Co.,Ltd

ClinicalTrials.gov NCT Identifier

NCT05516914

Study Number

LBL-007-CN-004

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