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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Platinum-resistant Recurrent Ovarian Cancer

In brief

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

Key facts

Study ID

NCT06434610

Run by

Shanghai Jiaolian Drug Research and Development Co., Ltd

People needed

90

Starts

2024-07-11

Expected to finish

2026-12-31

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;
• 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.

Where it is running

• Beijing Cancer Hospital — Beijing, China (enrolling)
• The First Affiliated Hospital of Bengbu Medical University — Bengbu, China (enrolling)
• XiangYa Hospital CentralSouth University — Changsha, China (enrolling)
• Fujian Cancer Hospital — Fuzhou, China (enrolling)
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, China (enrolling)
• Cancer Hospital of Shandong First Medical University — Jinan, China (enrolling)
• Qilu Hospital of Shandong University — Jinan, China (enrolling)
• Yunnan Cancer Hospital — Kunming, China (enrolling)
• Guangxi Medical University Cancer Hospital — Nanning, China (enrolling)
• Fudan University Shanghai Cancer center — Shanghai, China (enrolling)
• The Obstetrics & Gynecology Hospital of Fudan University — Shanghai, China (enrolling)
• The Second Hospital of Hebei Medical University — Shijiazhuang, China (enrolling)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, China (enrolling)
• Shananxi Provincial Cancer Hospital — Xi'an, China (enrolling)
• The First Affiliated Hospital of Xiamen University — Xiamen, China (enrolling)
• Yibin city second people's Hospital — Yibin, China (enrolling)
• Henan Cancer Hospital — Zhengzhou, China (enrolling)

Full record on ClinicalTrials.gov

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