A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.

April 29, 2026 updated by: Shanghai Jiaolian Drug Research and Development Co., Ltd

A Multicenter, Randomized, Double-blind, Parallel-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of B013 Combined With Paclitaxel in the Treatment of Platinum-resistant Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer.

To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
          • Hong Zheng
      • Bengbu, China
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical University
        • Contact:
          • Hongli Liu
      • Changsha, China
        • Recruiting
        • XiangYa Hospital CentralSouth University
        • Contact:
          • Yu Zhang
      • Fuzhou, China
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
          • Rong Xie
      • Guangzhou, China
        • Recruiting
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Contact:
          • Qunxian Rao
      • Jinan, China
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
          • Kun Song
      • Jinan, China
        • Recruiting
        • Cancer Hospital of Shandong First Medical University
        • Contact:
          • Liang Chen
      • Kunming, China
        • Recruiting
        • Yunnan Cancer Hospital
        • Contact:
          • Hongying Yang
      • Nanning, China
        • Recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
          • He Wang
      • Shanghai, China
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Xiaohua Wu
      • Shanghai, China
        • Recruiting
        • The Obstetrics & Gynecology Hospital of Fudan University
        • Contact:
          • Xin Lu
      • Shijiazhuang, China
        • Recruiting
        • The Second Hospital of Hebei Medical University
        • Contact:
          • Xianghua Huang
      • Wuhan, China
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Guiling Li
      • Xi'an, China
        • Recruiting
        • Shananxi Provincial Cancer Hospital
        • Contact:
          • Guoqing Wang
      • Xiamen, China
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Jianfa Lan
      • Yibin, China
        • Recruiting
        • Yibin city second people's Hospital
        • Contact:
          • Kaijian Lei
      • Zhengzhou, China
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Yanlin Luo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects who voluntarily participate in this study and sign informed consent form;
  2. Ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by histopathological examination and meeting the criteria for platinum resistance recurrence;
  3. ECOG performance status of 0 or 1；
  4. Expected survival > 12 weeks;
  5. The subject has at least one measurable lesion;
  6. Normal function of major organs;
  7. The fertile subjects agree to use reliable contraception from signing the informed consent to at least 6 months after the last dose.

Exclusion Criteria:

  1. Subjects who have received prescribed treatment previously;
  2. Subjects who are still using anti-tumor traditional Chinese patent medicines at the time of signing informed consent;
  3. Subjects with known central nervous system metastasis and multiple bone metastasis;
  4. Subjects who had clinical symptoms of pleural effusion, pericardial effusion or ascites before randomization and needed puncture drainage, or had received puncture drainage within the previous 2 weeks;
  5. Have a history of other malignant tumors within 5 years before signing the informed consent;
  6. Subjects with prescribed cardiovascular diseases;
  7. Subjects with infections requiring intravenous antibiotic infusion within 2 weeks prior to randomization;
  8. Had severe lung disease before randomization;
  9. Before randomization, the peripheral nerve toxicity of previous anti-tumor treatment was > grade 2, and other reversible toxicity was > grade 1;
  10. Subjects who had undergone surgery within 28 days prior to randomization and did not recover from adverse effects of surgery;
  11. Subjects who participated in clinical trials within 30 days prior to randomization and received other unmarketed investigational drugs;
  12. Subjects who are known to be allergic to any component of B013 or paclitaxel.
  13. Subjects with a known history of substance abuse, alcohol or drug use; Subjects with a known history of neurological or psychiatric disorders;
  14. Female subjects who are pregnant or breastfeeding;
  15. Other situations determined by the researchers and/or sponsors as unsuitable for participation in this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Paclitaxel
Paclitaxel: 80 mg/m^2 is administered weekly on Day 1, 8, 15 of each 28-day cycle.
Drug: Placebo
Placebo: The subjects will receive IV dose of placebo matched to B013 on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.
Experimental: B013
Drug: B013
B013: The subjects will receive IV dose of B013 600 mg on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.
Drug: Paclitaxel
Paclitaxel: 80 mg/m^2 is administered weekly on Day 1, 8, 15 of each 28-day cycle.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Approximately 2 years
From the date of randomization to the date of progression disease or death , whichever occurred first.
Approximately 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Approximately 2 years
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Approximately 2 years
Disease control rate (DCR)
Time Frame: Approximately 2 years
DCR was defined as the percentage of participants who have achieved complete response, partial response and stable disease.
Approximately 2 years
Duration of remission (DOR)
Time Frame: Approximately 5 years
DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause.
Approximately 5 years
Overall Survival (OS)
Time Frame: Approximately 2 years
Determination of the overall survival times of all participants.
Approximately 2 years
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Approximately 5 years
The incidence of adverse event (regardless of its relationship to study drug) will be classified using MedDRA and the severity of each adverse event will be graded using NCI CTCAE v5.0.
Approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Jiaolian Drug Research and Development Co., Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Pharmaceuticals Holding Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPH-B013-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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