Ovarian CancerPhase 1/2NCT07042802
A Study of LBL-024 in Combination With Paclitaxel ± Bevacizumab for the Treatment of Platinum-resistant Ovarian Cancer
A Phase 1/2 study testing LBL-024 for Injection, Paclitaxel injection and Bevacizumab injection in people with Ovarian Cancer, run by Nanjing Leads Biolabs Co.,Ltd at 13 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- LBL-024 for Injection, Paclitaxel injection and Bevacizumab injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 13 sitesChina
- Study dates
- 2 Dec 2025to 25 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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 Participants 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.
Who cannot join
- 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.
- Use of immunomodulatory drugs within 2 weeks prior to the first use of study drug.
- 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.
- Participants with clinically uncontrollable pleural effusion, pericardial effusion or ascites, and those requiring repeated drainage or medical intervention.
- The Participants has a Medical history of immunodeficiency, including HIV antibody positive.
- Active hepatitis B or active hepatitis C.
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- 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 Participants has other conditions that may affect compliance or are not suitable for participating in this study.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
AnYang Tumor Hospital
Anyang, Henan, 455000
dongtao meng, 02583378099, mengdongtao@leadsbiolabs.com
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
dongtao meng, 025-83378099, mengdongtao@leadsbiolabs.com
- Not yet recruiting
Beijing Obstetrics and Gynecology Hospital Capital Medical University
Beijing, Beijing Municipality, 100026
dongtao meng, 02583378099, mengdongtao@leadsbiolabs.com
- Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
dongtao meng, 02583378099, mengdongtao@leadsbiolabs.com
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
dongtao meng, 02583378099, mengdongtao@leadsbiolabs.com
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
dongtao meng, 025-83378099, mengdongtao@leadsbiolabs.com
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
dongtao meng, 02583378099, mengdongtao@leadsbiolabs.com
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
dongtao meng, 025-83378099, mengdongtao@leadsbiolabs.com
- Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650106
dongtao meng, 025-83378099, mengdongtao@leadsbiolabs.com
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
dongtao meng, 025-83378099, mengdongtao@leadsbiolabs.com
- Recruiting
Tianjin Medical University Cancer Institute &Hospital
Tianjin, Tianjin Municipality, 300060
dongtao meng, 025-83378099, mengdongtao@leadsbiolabs.com
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006
dongtao meng, 02583378099, mengdongtao@leadsbiolabs.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
dongtao meng, 02583378099, mengdongtao@leadsbiolabs.com
About this study
Official title: 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).
Read the detailed description
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.
- Conditions
- Ovarian Cancer
- Being tested
- LBL-024 for Injection, Paclitaxel injection, Bevacizumab injection
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBL-024 for InjectionDrug
Also called LBL-024
Intravenous infusion.
Paclitaxel injectionDrug
Also called Paclitaxel
Intravenous infusion.
Bevacizumab injectionDrug
Also called Bevacizumab
Intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| LBL-024 + Paclitaxel injection | Experimental | LBL-024 + Paclitaxel injection.
Intravenous infusion. Receives: Drug: LBL-024 for Injection; Drug: Paclitaxel injection |
| LBL-024 + Paclitaxel injection + bevacizumab | Experimental | LBL-024 + Paclitaxel injection + bevacizumab.
Intravenous infusion. Receives: Drug: LBL-024 for Injection; Drug: Paclitaxel injection; Drug: Bevacizumab injection |
| LBL-024 in Combination With paclitaxel ± bevacizumab | Experimental | LBL-024 in Combination With paclitaxel ± bevacizumab.
Intravenous infusion. Receives: Drug: LBL-024 for Injection; Drug: Paclitaxel injection; Drug: Bevacizumab injection |
| Paclitaxel ± bevacizumab | Active comparator | Paclitaxel ± bevacizumab.
Intravenous infusion. Receives: Drug: Paclitaxel injection; Drug: Bevacizumab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
Secondary outcomes (5)
Cmax
Maximum drug concentration in plasma after administration.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start2 Dec 2025
- Primary completion25 Dec 2027 (estimated)
- Study completion25 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Nanjing Leads Biolabs Co.,LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Leads Biolabs Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- lingying wu, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042802
- Sponsor's protocol ID
- LBL-024-CN006
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07042802
- Acronym / sponsor ID
- LBL-024-CN006
- Conditions
- Ovarian Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Nanjing Leads Biolabs Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 25 Dec 2027 (estimated)
- Study completion
- 25 Dec 2028 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LBL-024 + Paclitaxel injection | Experimental | Drug: LBL-024 for Injection, Drug: Paclitaxel injectionLBL-024 + Paclitaxel injection. Intravenous infusion. |
| LBL-024 + Paclitaxel injection + bevacizumab | Experimental | Drug: LBL-024 for Injection, Drug: Paclitaxel injection, Drug: Bevacizumab injectionLBL-024 + Paclitaxel injection + bevacizumab. Intravenous infusion. |
| LBL-024 in Combination With paclitaxel ± bevacizumab | Experimental | Drug: LBL-024 for Injection, Drug: Paclitaxel injection, Drug: Bevacizumab injectionLBL-024 in Combination With paclitaxel ± bevacizumab. Intravenous infusion. |
| Paclitaxel ± bevacizumab | Active comparator | Drug: Paclitaxel injection, Drug: Bevacizumab injectionPaclitaxel ± bevacizumab. Intravenous infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 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 Participants enrolled have at least one measurable lesion.
Key exclusion criteria (9 listed)
- 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.
- Use of immunomodulatory drugs within 2 weeks prior to the first use of study drug.
- 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.
- Participants with clinically uncontrollable pleural effusion, pericardial effusion or ascites, and those requiring repeated drainage or medical intervention.
- The Participants has a Medical history of immunodeficiency, including HIV antibody positive.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LBL-024 for InjectionAlso: LBL-024Intravenous infusion. | Drug | LBL-024 + Paclitaxel injection, LBL-024 + Paclitaxel injection + bevacizumab, LBL-024 in Combination With paclitaxel ± bevacizumab |
| Paclitaxel injectionAlso: PaclitaxelIntravenous infusion. | Drug | LBL-024 + Paclitaxel injection, LBL-024 + Paclitaxel injection + bevacizumab, LBL-024 in Combination With paclitaxel ± bevacizumab, Paclitaxel ± bevacizumab |
| Bevacizumab injectionAlso: BevacizumabIntravenous infusion. | Drug | LBL-024 + Paclitaxel injection + bevacizumab, LBL-024 in Combination With paclitaxel ± bevacizumab, Paclitaxel ± bevacizumab |
Primary outcome
Objective Response Rate (ORR)
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)
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.
Occurrence of adverse event (AE) and serious adverse event (SAE)
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)
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.
Progression-free Survival(PFS)
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)
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.
5 secondary outcomes
Cmax
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
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
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
lingying wu principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LBL-024 for Injection, Paclitaxel injection and Bevacizumab injection in people with Ovarian Cancer, run by Nanjing Leads Biolabs Co.,Ltd at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact lingying wu (025-83378099, mengdongtao@leadsbiolabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.