A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer

A Randomized, Double-blind, Phase III Study of BD0801 Injection Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in Patients With Recurrent, Platinum-resistant Epithelial Ovarian, Fallopian Tube , or Primary Peritoneal Cancer.

The standard systemic treatment for ovarian cancer is platinum-based chemotherapy. However, majority of patients relapse and eventually progress to platinum resistance. In patients with platinum-resistant or refractory ovarian cancer, effective treatment options are limited and the prognosis is very poor. Angiogenesis is essential for tumor growth and metastasis, and VEGF/VEGF receptor(VEGFR) signaling pathway is the most promising angiogenic target. This study aim to assess the efficacy and safety of the combination BD0801 and chemotherapy in patients with platinum-resistant recurrent ovarian cancer.

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: BD0801; Drug: Paclitaxel; Drug: Topotecan; Drug: doxorubicin liposome; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 421
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China
      • The First Affiliated Hospital of Bengbu Medical University
    • Hefei, Anhui, China
      • The Second Hospital of Anhui Medical University
    • Hefei, Anhui, China
      • The First Affiliated Hospital of USTC West District,Anhui Provincial Cancer Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Cancer Hospital Chinese Academy of Medical Sciences
    • Beijing, Beijing Municipality, China
      • Beijing Obstetrics and Gynecology Hospital, Capital Medical University
    • Beijing, Beijing Municipality, China
      • Peking University First Hospital
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • Chongqing Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China
      • Fujian Provincial Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Sun Yat-sen University Cancer Center
    • Guangzhou, Guangdong, China
      • ZhuJiang Hospital of Southern Medical University
    • Shantou, Guangdong, China
      • Cancer Hospital of Shantou University Medical College
    • Shenzhen, Guangdong, China
      • Cancer hospital Chinese Academy of Medical Sciences, Shenzhen Center
  • Guangxi
    • Nanning, Guangxi, China
      • Guangxi Medical University Cancer Hospital&Guangxi Cancer Institute, Guangxi Cancer Hospital&Medical University School&Cancer Center
  • Guizhou
    • Guiyang, Guizhou, China
      • Guizhou Provincial People's Hospital
  • Hainan
    • Haikou, Hainan, China
      • Hainan General Hospital
  • Hebei
    • Shijiazhuang, Hebei, China
      • The Second Hospital of Hebei Medical University
    • Shijiazhuang, Hebei, China
      • The Fourth Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Harbin medical university cancer hospital
  • Henan
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China
      • The Second Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China
      • The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Hubei Cancer Hospital
    • Wuhan, Hubei, China
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • Hunan Cancer hospital
    • Changsha, Hunan, China
      • The second Xiangya Hospital of Central South University
    • Hengyang, Hunan, China
      • The First Affiliated Hospital of University of South China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Jiangsu Cancer Hospital
    • Nanjing, Jiangsu, China
      • Nanjing Women and Children's Healthcare Hospital, Women's Hospital of Nanjing Medical University
    • Nantong, Jiangsu, China
      • Nantong Cancer Hospital
    • Xuzhou, Jiangsu, China
      • Xuzhou Central Hospital(Southeast University Affiliated Hospital)
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Jiangxi Maternal and Child Health Hospital
  • Jilin
    • Changchun, Jilin, China
      • The First Hospital of Jilin University
    • Changchun, Jilin, China
      • Jilin Cancer Hospital
    • Changchun, Jilin, China
      • The Second Norman Bethune Hospital of Jilin University
  • Liaoning
    • Dalian, Liaoning, China
      • The Second Hospital of Dalian Medical University
    • Fushun, Liaoning, China
      • Fukuang General Hospital of Liaoning Health Industry Group
    • Shenyang, Liaoning, China
      • Shengjing Hospital Of China Medical University
    • Shenyang, Liaoning, China
      • Liaoning Cancer Hospital & Institute
  • Shaanxi
    • Xi'an, Shaanxi, China
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Shandong
    • Jinan, Shandong, China
      • Qilu Hospital of Shandong University
    • Jinan, Shandong, China
      • Shandong Cancer Hospital & Institute
    • Jining, Shandong, China
      • Affiliated Hospital of Jining Medical University
    • Linyi, Shandong, China
      • Linyi Cancer Hospital
    • Yantai, Shandong, China
      • Yantai Yuhuangding Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Obstetrics & Gynecology Hospital of Fudan University
  • Shanxi
    • Taiyuan, Shanxi, China
      • Second Hospital of Shanxi Medical University
  • Sichuan
    • Mianyang, Sichuan, China
      • Mianyang Central Hospital
    • Nanchong, Sichuan, China
      • Affiliated Hospital of North Sichuan Medical College
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China
      • Tianjin Center Hospital of Gynecology Obstetrics
    • Tianjin, Tianjin Municipality, China
      • Tianjin Medical University Cancer Institute & Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China
      • Zhejiang Provincial People's Hospital
    • Hangzhou, Zhejiang, China
      • The Second Affiliated Hospital Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China
      • Hangzhou Cancer Hospital
    • Wenzhou, Zhejiang, China
      • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• female patients, >/=18 years of age;
• epithelial ovarian, fallopian tube or primary peritoneal cancer;
• platinum-resistant disease (disease progression within <6 months of platinum therapy)
• Eastern Cooperative Oncology Group（ECOG）performance status of 0-1

Exclusion Criteria:

• non-epithelial tumours
• ovarian tumours with low malignant potential
• Received 1 line of systemic therapy for ovarian cancer following platinum resistance and/or > 1 line of non-platinum systemic therapy prior to platinum resistance.
• prior radiotherapy to the pelvis or abdomen

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BD0801+chemotherapy; BD0801 is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.	Drug: BD0801; Subjects receive BD0801 , intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg; Drug: Paclitaxel; Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, d22, q4w, Dosage form: injectable, Strength: 80 mg/m2; Drug: Topotecan; Subjects receive Topotecan, intravenously, d1, d8, d15, q4w, Dosage form: injectable, Strength: 4mg/m2; Drug: doxorubicin liposome; Subjects receive doxorubicin liposome, intravenously, d1, , q4w, Dosage form: injectable, Strength: 40mg/m2
Placebo Comparator: Placebo+chemotherapy; Placebo is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.	Drug: Paclitaxel; Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, d22, q4w, Dosage form: injectable, Strength: 80 mg/m2; Drug: Topotecan; Subjects receive Topotecan, intravenously, d1, d8, d15, q4w, Dosage form: injectable, Strength: 4mg/m2; Drug: doxorubicin liposome; Subjects receive doxorubicin liposome, intravenously, d1, , q4w, Dosage form: injectable, Strength: 40mg/m2; Drug: Placebo; Subjects receive Placebo, intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival(PFS) by blinded independent review committee(BIRC)	PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the IRC according to the RECIST 1.1 criteria	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is the time interval from the date of randomization to death from any cause.	2.5 year
PFS by investigator	PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigator according to the RECIST1.1 criteria	2 year
Objective Response Rate (ORR) by investigator	Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria	2 year
Disease Control Rate (DCR) by investigator	Proportion of subjects who have a complete or partial response, or stable disease relative to baseline as assessed by investigator according to RECIST 1.1 criteria	2 year
Objective Response Rate (DOR) by investigator	Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.	2 year
ORR by BIRC	Proportion of subjects who have a complete or partial response relative to baseline as assessed by BIRC according to RECIST 1.1 criteria	2 year
DCR by BIRC	Proportion of subjects who have a complete or partial response, or stable disease relative to baseline as assessed by BIRC according to RECIST 1.1 criteria	2 year
DOR by BIRC	Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.	2 year
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)	Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0	2.5 year
Quality Of Life (QoL)	use European Organisation for Research and Treatment of Cance（EORTC）- QLQ-C30 questionnaire	2.5 year
Quality Of Life (QoL)	use EORTC-QLQ-OV28 questionnaire	2.5 year
Serum drug concentrations of BD0801	Serum drug concentrations of BD0801 will be calculated.	2 year
rate of immunogenicity positive reaction		2 year
duration of immunogenicity positive reaction		2 year

Collaborators and Investigators

• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Collaborators: Shanghai Xianxiang Medical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2021
• Primary Completion (Actual): December 8, 2023
• Study Completion (Actual): October 11, 2024

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Ovarian Neoplasms; Organic Chemicals; Heterocyclic Compounds; Substandard Drugs; Pharmaceutical Preparations; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Carbohydrates; Camptothecin; Alkaloids; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glycosides; Taxoids; Cyclodecanes; Diterpenes; Anthracyclines; Naphthacenes; Aminoglycosides; Daunorubicin; Doxorubicin; Paclitaxel; Topotecan; Counterfeit Drugs
• Other Study ID Numbers: SIM-63-OC-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No