A Phase 1/2 interventional study of LBL-024 for Injection and Paclitaxel injection in Ovarian Cancer, sponsored by Nanjing Leads Biolabs Co.,Ltd. Recruiting at 13 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Nanjing Leads Biolabs Co.,Ltd · Phase 1/2, Interventional, and Treatment
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 180 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Nanjing Leads Biolabs Co.,Ltd is the lead sponsor of 20 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
LBL-024 + Paclitaxel injection. Intravenous infusion.
Drug: LBL-024 for Injection · Drug: Paclitaxel injection
LBL-024 + Paclitaxel injection + bevacizumab. Intravenous infusion.
Drug: LBL-024 for Injection · Drug: Paclitaxel injection · Drug: Bevacizumab injection
LBL-024 in Combination With paclitaxel ± bevacizumab. Intravenous infusion.
Drug: LBL-024 for Injection · Drug: Paclitaxel injection · Drug: Bevacizumab injection
Paclitaxel ± bevacizumab. Intravenous infusion.
Drug: Paclitaxel injection · Drug: Bevacizumab injection
Intravenous infusion.
Also known as: LBL-024
Intravenous infusion.
Also known as: Paclitaxel
Intravenous infusion.
Also known as: Bevacizumab
Objective Response Rate (ORR)
According to the evaluation criteria of RECIST V1.1 (solid tumour) ,Proportion of subjects achieving complete response (CR) or partial response (PR).It was used to evaluate the efficacy in Phase Ib.
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Occurrence of adverse event (AE) and serious adverse event (SAE)
Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-024 in combination with paclitaxel will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) in Phase Ib study.
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy)
Progression-free Survival(PFS)
According to the evaluation criteria of RECIST V1.1 (solid tumour),Time from randomisation to disease progression or death from any cause.It was used to evaluate Time of disease no-progression or Drug resistance in Phase II.
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Cmax
Maximum drug concentration in plasma after administration.
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Tmax
After administration,Time to reach maximum drug concentration in plasma.
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Immunogenicity
The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects.Immunogenicity refers to the performance that can elicit an immune response.
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Disease Control Rate(DCR)
Percentage of participants achieving CR, PR, iCR, iPR and stable disease (SD) after treatment.
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Duration of Response(DOR)
DOR is defined as the duration from earliest date of disease response (CR、PR 、iCR or iPR) until earliest date of disease progression or death from any cause(if occurring sooner than progression).
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Plan to share: No
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Nanjing Leads Biolabs Co.,Ltd