A Study of LBL-024 in Combination With Paclitaxel ± Bevacizumab for the Treatment of Platinum-resistant Ovarian Cancer

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

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

The trial consists of two phases: Phase Ib and Phase II.

Phase Ib is a single arm, open label, safety and efficacy exploration phase, which includes two cohorts with different dosing regimens. The two cohorts can be conducted simultaneously. After completion of Phase Ib, the sponsor and investigators will jointly evaluate the safety, tolerance and preliminary efficacy of combination treatment. Based on this evaluation, they will decide to continue Phase II study with the current protocol or adjust the design of Phase II study before initiating the study.

Phase II is an open-label, randomized, positive-controlled extension study in which eligible participants were randomly assigned to the trial group or control group at a ratio of 2:1.

This study plans toenroll up to 180 subjects.

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.