New hope for hard-to-treat ovarian cancer: experimental combo enters phase 2 trial
NCT ID NCT06434610
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding the experimental drug B013 to standard chemotherapy (paclitaxel) can help people with ovarian, fallopian tube, or primary peritoneal cancer that has stopped responding to platinum-based treatments. About 90 participants will receive either the combination or a placebo plus chemotherapy. The main goal is to see if the combination delays cancer growth or death.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2024
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Fallopian tube cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
17 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Beijing Cancer Hospital
RECRUITINGBeijing, China
-
Cancer Hospital of Shandong First Medical University
RECRUITINGJinan, China
-
Fudan University Shanghai Cancer center
RECRUITINGShanghai, China
-
Fujian Cancer Hospital
RECRUITINGFuzhou, China
-
Guangxi Medical University Cancer Hospital
RECRUITINGNanning, China
-
Henan Cancer Hospital
RECRUITINGZhengzhou, China
-
Qilu Hospital of Shandong University
RECRUITINGJinan, China
-
Shananxi Provincial Cancer Hospital
RECRUITINGXi'an, China
-
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITINGGuangzhou, China
-
The First Affiliated Hospital of Bengbu Medical University
RECRUITINGBengbu, China
-
The First Affiliated Hospital of Xiamen University
RECRUITINGXiamen, China
-
The Obstetrics & Gynecology Hospital of Fudan University
RECRUITINGShanghai, China
-
The Second Hospital of Hebei Medical University
RECRUITINGShijiazhuang, China
-
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITINGWuhan, China
-
XiangYa Hospital CentralSouth University
RECRUITINGChangsha, China
-
Yibin city second people's Hospital
RECRUITINGYibin, China
-
Yunnan Cancer Hospital
RECRUITINGKunming, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Patient's own immune cells fight ovarian cancer?
- Ovarian Cancer's spread: scientists probe abdominal fluid for clues
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Can a new drug combo keep ovarian cancer from coming back?
- New drug takes aim at ovarian cancers that resist platinum chemotherapy
- Can engineered immune cells outsmart Drug-Resistant ovarian cancer?