LBL-024 combined with paclitaxel for platinum-resistant ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multicenter Phase Ib/II trial begins with a Phase Ib safety lead-in where a small cohort receives LBL-024 plus paclitaxel on 21-day cycles to assess tolerability and guide dose de-escalation. If safety and tolerability are acceptable, the study expands to a randomized Phase II cohort that assigns participants 2:1 to LBL-024 plus paclitaxel versus paclitaxel alone to compare efficacy and safety. Tumor response will be measured by RECIST 1.1 and adverse events will be monitored to inform dosing and continuation. The trial plans to enroll up to 110 participants across several centers in China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Agree to follow the trial treatment regimen, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent.
2. At the time of signing the informed consent form, the age was ≥ 18 years old.
3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1.
4. The expected survival time is at least 12 weeks.
5. According to the evaluation of RECIST 1.1 （Response Evaluation Criteria in Solid Tumours），the Participants enrolled have at least one measurable lesion.
6. Females of childbearing age are willing to take highly effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug;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. The Participants is currently participating in any other clinical trial,Or has received or is receiving other investigational agents within 4 weeks prior to the first dose of study drug.
2. Use of immunomodulatory drugs within 2 weeks prior to the first use of study drug.
3. Participants with active infection and currently requiring systemic treatment. active pulmonary tuberculosis (TB), receiving anti-tuberculosis treatment or Received anti-tuberculosis treatment within 6 months before screening.
4. Participants with clinically uncontrollable pleural effusion, pericardial effusion or ascites, and those requiring repeated drainage or medical intervention.
5. The Participants has a Medical history of immunodeficiency, including HIV antibody positive.
6. Active hepatitis B or active hepatitis C.
7. Women during pregnancy or lactation.
8. History of mental and/or psychiatric illness (impairing understanding or giving informed consent), drug abuse, alcoholism, or drug addiction.
9. The investigator believes that the Participants has other conditions that may affect compliance or are not suitable for participating in this study.

Where it's running

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting
• AnYang Tumor Hospital
  Anyang, Henan, China Recruiting
• The Affiliated Hospital of Xuzhou Medical University
  Xuzhou, Jiangsu, China Recruiting
• The First Hospital of China Medical University
  Shenyang, Liaoning, China Recruiting
• Shandong Cancer Hospital
  Jinan, Shandong, China Recruiting
• Tianjin Medical University Cancer Institute &Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: lingying wu — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: lingying wu
• Email: mengdongtao@leadsbiolabs.com
• Phone: 025-83378099

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.