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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Shanghai Jiaolian Drug Research and Development Co., Ltd

Collaborators

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)

July 11, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 23, 2024

First Submitted That Met QC Criteria

May 23, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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