A Phase Ib/Ⅱ Clinical Trial of LBL-024 Combined With Paclitaxel in Patients With Platinum-resistant Ovarian Cancer

Recruiting now · Phase 1/Phase 2

Conditions studied: Ovarian Cancer

In brief

This trial is an open-label, multicenter phase Ib/II clinical study of LBL-024 combination therapy in patients with platinum-resistant ovarian cancer (OC),To evaluate the efficacy and safety of LBL-024 combination therapy in the treatment of advanced recurrent platinum-resistant ovarian cancer (OC) patients.

Key facts

Study ID

NCT07042802

Run by

Nanjing Leads Biolabs Co.,Ltd

People needed

110

Starts

2025-12-02

Expected to finish

2028-12-25

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• At the time of signing the informed consent form, the age was ≥ 18 years old, and the gender was not limited.
• The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1.
• The expected survival time is at least 12 weeks.
• According to the evaluation of RECIST 1.1 （Response Evaluation Criteria in Solid Tumours），the subjects enrolled have at least one measurable lesion.
• 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.

You may not qualify if…

• The subject 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.
• Use of immunomodulatory drugs within 2 weeks prior to the first use of study drug.
• Patients 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.
• Patients with clinically uncontrollable pleural effusion, pericardial effusion or ascites, and those requiring repeated drainage or medical intervention.
• The patient has a Medical history of immunodeficiency, including HIV antibody positive.
• Active hepatitis B or active hepatitis C.
• Women during pregnancy or lactation.
• History of mental and/or psychiatric illness (impairing understanding or giving informed consent), drug abuse, alcoholism, or drug addiction.
• The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

Where it is running

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)
• The First Hospital of China Medical University — Shenyang, Liaoning, China (enrolling)
• Shandong Cancer Hospital — Jinan, Shandong, China (enrolling)
• Tianjin Medical University Cancer Institute &Hospital — Tianjin, Tianjin Municipality, China (enrolling)
• Yunnan Cancer Hospital — Kunming, Yunnan, China (enrolling)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (enrolling)
• AnYang Tumor Hospital — Anyang, Henan, China (enrolling)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (enrolling)
• Beijing Obstetrics and Gynecology Hospital Capital Medical University — Beijing, Beijing Municipality, China
• Fujian Cancer Hospital — Fuzhou, Fujian, China
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China

Full record on ClinicalTrials.gov

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