Platinum-resistant Recurrent Ovarian CancerPhase 2NCT06434610
A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.
A Phase 2 study testing B013 and Paclitaxel in people with Platinum-resistant Recurrent Ovarian Cancer, run by Shanghai Jiaolian Drug Research and Development Co., Ltd at 17 sites in China.
Trial summary
To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Platinum-resistant Recurrent Ovarian Cancer
- What is being tested?
- B013 and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 17 sitesChina
- Study dates
- 11 Jul 2024to 31 Dec 2026
- Phase
- Phase 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who voluntarily participate in this study and sign informed consent form;
- Ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by histopathological examination and meeting the criteria for platinum resistance recurrence;
- ECOG performance status of 0 or 1；
- Expected survival > 12 weeks;
- The subject has at least one measurable lesion;
- Normal function of major organs;
- The fertile subjects agree to use reliable contraception from signing the informed consent to at least 6 months after the last dose.
Who cannot join
- Subjects who have received prescribed treatment previously;
- Subjects who are still using anti-tumor traditional Chinese patent medicines at the time of signing informed consent;
- Subjects with known central nervous system metastasis and multiple bone metastasis;
- 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;
- Have a history of other malignant tumors within 5 years before signing the informed consent;
- Subjects with prescribed cardiovascular diseases;
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- Subjects with infections requiring intravenous antibiotic infusion within 2 weeks prior to randomization;
- Had severe lung disease before randomization;
- Before randomization, the peripheral nerve toxicity of previous anti-tumor treatment was > grade 2, and other reversible toxicity was > grade 1;
- Subjects who had undergone surgery within 28 days prior to randomization and did not recover from adverse effects of surgery;
- Subjects who participated in clinical trials within 30 days prior to randomization and received other unmarketed investigational drugs;
- Subjects who are known to be allergic to any component of B013 or paclitaxel.
- Subjects with a known history of substance abuse, alcohol or drug use; Subjects with a known history of neurological or psychiatric disorders;
- Female subjects who are pregnant or breastfeeding;
- Other situations determined by the researchers and/or sponsors as unsuitable for participation in this trial.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
China17 sites, 17 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
Hong Zheng
- Recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu
Hongli Liu
- Recruiting
XiangYa Hospital CentralSouth University
Changsha
Yu Zhang
- Recruiting
Fujian Cancer Hospital
Fuzhou
Rong Xie
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou
Qunxian Rao
- Recruiting
Cancer Hospital of Shandong First Medical University
Jinan
Liang Chen
- Recruiting
Qilu Hospital of Shandong University
Jinan
Kun Song
- Recruiting
Yunnan Cancer Hospital
Kunming
Hongying Yang
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning
He Wang
- Recruiting
Fudan University Shanghai Cancer center
Shanghai
Xiaohua Wu
- Recruiting
The Obstetrics & Gynecology Hospital of Fudan University
Shanghai
Xin Lu
- Recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang
Xianghua Huang
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Guiling Li
- Recruiting
Shananxi Provincial Cancer Hospital
Xi'an
Guoqing Wang
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
Jianfa Lan
- Recruiting
Yibin city second people's Hospital
Yibin
Kaijian Lei
- Recruiting
Henan Cancer Hospital
Zhengzhou
Yanlin Luo
About this study
Official title: 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.
- Being tested
- B013, Paclitaxel, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B013Drug
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.
PaclitaxelDrug
Paclitaxel: 80 mg/m^2 is administered weekly on Day 1, 8, 15 of each 28-day cycle.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| B013 | Experimental | Not described Receives: Drug: B013; Drug: Paclitaxel |
| Placebo | Placebo comparator | Not described Receives: Drug: Paclitaxel; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
From the date of randomization to the date of progression disease or death , whichever occurred first.
Measured: Approximately 2 years
Secondary outcomes (5)
Objective response rate (ORR)
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Measured: Approximately 2 years
Disease control rate (DCR)
DCR was defined as the percentage of participants who have achieved complete response, partial response and stable disease.
Measured: Approximately 2 years
Duration of remission (DOR)
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.
Measured: Approximately 5 years
Overall Survival (OS)
Determination of the overall survival times of all participants.
Measured: Approximately 2 years
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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.
Measured: Approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start11 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platinum-resistant Recurrent Ovarian CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiaolian Drug Research and Development Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Pharmaceuticals Holding Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434610
- Sponsor's protocol ID
- SPH-B013-201
- Status last verified
- Apr 2026
- First submitted
- 23 May 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06434610
- Acronym / sponsor ID
- SPH-B013-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai Jiaolian Drug Research and Development Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Pharmaceuticals Holding Co., Ltd
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 May 2024 (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.
To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B013 | Experimental | Drug: B013, Drug: Paclitaxel |
| Placebo | Placebo comparator | Drug: Paclitaxel, Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who voluntarily participate in this study and sign informed consent form;
- Ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by histopathological examination and meeting the criteria for platinum resistance recurrence;
- ECOG performance status of 0 or 1；
- Expected survival > 12 weeks;
- The subject has at least one measurable lesion;
Key exclusion criteria (15 listed)
- Subjects who have received prescribed treatment previously;
- Subjects who are still using anti-tumor traditional Chinese patent medicines at the time of signing informed consent;
- Subjects with known central nervous system metastasis and multiple bone metastasis;
- 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;
- Have a history of other malignant tumors within 5 years before signing the informed consent;
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 |
|---|---|---|
| B013B013: 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 | B013 |
| PaclitaxelPaclitaxel: 80 mg/m^2 is administered weekly on Day 1, 8, 15 of each 28-day cycle. | Drug | B013, Placebo |
| PlaceboPlacebo: 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. | Drug | Placebo |
Primary outcome
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.
5 secondary outcomes
Objective response rate (ORR)
Time frame: Approximately 2 years
Disease control rate (DCR)
Time frame: Approximately 2 years
Duration of remission (DOR)
Time frame: Approximately 5 years
Overall Survival (OS)
Time frame: Approximately 2 years
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Approximately 5 years
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 5 May 2026.
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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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing B013 and Paclitaxel in people with Platinum-resistant Recurrent Ovarian Cancer, run by Shanghai Jiaolian Drug Research and Development Co., Ltd at 17 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 7 inclusion and 15 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 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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 Xiaohua Wu (0086-021-64175590, JJYIN555@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Approximately 2 years). 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 5 May 2026.