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

An Open-label, Multicenter Phase Ib/Ⅱ Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Paclitaxel Injection in Patients With Platinum-resistant Ovarian Cancer

This trial tests whether adding the new drug LBL-024 to paclitaxel helps people with platinum-resistant ovarian cancer and is safe.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nanjing Leads Biolabs Co.,Ltd (industry)
• Locations: 13 sites (Beijing, Beijing Municipality and 12 other locations)
• Trial ID: NCT07042802 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with platinum-resistant ovarian cancer, ECOG performance status 0–1, at least one measurable lesion by RECIST 1.1, expected survival ≥12 weeks, and who can comply with treatment and contraception requirements are the intended participants.

Not a fit: Patients with ECOG >1, no measurable disease, contraindications to paclitaxel or the investigational drug, or who cannot meet contraceptive or visit requirements are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the combination could improve response rates or delay disease progression compared with paclitaxel alone for patients with platinum-resistant ovarian cancer.

How similar studies have performed: Previous trials combining novel agents with paclitaxel in platinum-resistant ovarian cancer have shown mixed results, with some improving response rates but few demonstrating substantial survival benefits.

Eligibility criteria

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, and the gender was not limited.
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 subjects 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 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.
2. Use of immunomodulatory drugs within 2 weeks prior to the first use of study drug.
3. 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.
4. Patients with clinically uncontrollable pleural effusion, pericardial effusion or ascites, and those requiring repeated drainage or medical intervention.
5. The patient 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 subject has other conditions that may affect compliance or are not suitable for participating in this study.

Where this trial is running

Beijing, Beijing Municipality and 12 other locations

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (RECRUITING)
• Beijing Obstetrics and Gynecology Hospital Capital Medical University — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (NOT_YET_RECRUITING)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (NOT_YET_RECRUITING)
• AnYang Tumor Hospital — Anyang, Henan, China (RECRUITING)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (NOT_YET_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)
• Yunnan Cancer Hospital — Kunming, Yunnan, China (RECRUITING)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Principal investigator: lingying wu — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: lingying wu

Conditions: Ovarian Cancer