Can a targeted drug combo outsmart returning ovarian cancer?
NCT ID NCT07776171
First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This phase II trial is testing whether a new drug, trastuzumab rezetecan, combined with carboplatin (and sometimes bevacizumab) can help people with platinum-sensitive recurrent ovarian cancer. Participants will be randomly assigned to receive either this experimental combination or one of several standard chemotherapy options. The study aims to see if the new approach delays cancer progression better than current treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- trastuzumab rezetecan (SHR-A1811) combined with carboplatin, with or without bevacizumab
- What this could lead to
- If successful, this could offer a new, more effective treatment option for people with recurrent ovarian cancer that has returned after platinum-based therapy.
- What could go wrong
- This is a phase II trial, so results are preliminary. The experimental combination may not prove better than standard chemotherapy and could carry additional side effects.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 176 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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May 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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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 voluntarily participate in this study, sign the informed consent form, and have good compliance. 2. Aged 18 to 75 years. 3. Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. 4. Have received 1-3 prior lines of platinum-based chemotherapy and have experienced disease progression or recurrence ≥6 months after the last platinum-based treatment (platinum-sensitive relapse). 5. Must have received prior treatment with a PARP inhibitor. 6. Able to provide sufficient fresh or archival tumor tissue specimens for detection of HER2 expression levels. 7. Have at least one measurable lesion per RECIST v1.1. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 9. Expected survival of more than 3 months. 10. Adequate major organ function. 11. Subjects of childbearing potential must use at least one medically approved contraceptive measure (e.g., intrauterine device, contraceptive pill, or condom) during the study treatment period and for 180 days after the end of study treatment; must have a negative serum/urine HCG test before the first dose; and must not be breastfeeding. Exclusion Criteria: 1. Ovarian cancer with pathological types of clear cell carcinoma, low-grade serous adenocarcinoma, or mucinous adenocarcinoma. 2. Known allergy to any component of trastuzumab rezetecan; known allergy to carboplatin. 3. Prior treatment with anti-HER2 therapy, an antibody-drug conjugate (ADC) containing a topoisomerase I inhibitor, or a topoisomerase I inhibitor alone. 4. Untreated or active central nervous system (CNS) metastases. 5. Prior history of interstitial pneumonia/interstitial lung disease or non-infectious pneumonitis (e.g., radiation pneumonitis) that required steroid treatment; current or suspected interstitial pneumonia/interstitial lung disease, non-infectious pneumonitis, or other active pneumonitis. 6. Active ulcer, intestinal perforation, or intestinal obstruction. 7. Known hereditary or acquired bleeding disorders (e.g., coagulation dysfunction, hemophilia) or thrombotic tendency. 8. Toxicity from prior anti-tumor therapy that has not recovered to ≤ Grade 1 per NCI-CTCAE v6.0. 9. Arterial/venous thrombotic events (including but not limited to cerebrovascular accident, deep vein thrombosis, and pulmonary embolism) within 6 months before the first dose; however, if muscular venous thrombosis or catheter-related thrombosis associated with an infusion port is present before the first dose and the investigator deems it to be without risk, the subject may be enrolled. 10. Hypertension not well controlled with antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg). 11. Uncontrolled or severe cardiovascular disease, such as unstable angina, symptomatic congestive heart failure (NYHA class II-IV), myocardial infarction within 6 months before the first dose, or unstable angina or unstable arrhythmia within 1 month before the first dose. 12. Prior surgery, radical radiotherapy, chemotherapy, macromolecular targeted therapy, or anti-tumor immunotherapy with completion (last dose) less than 4 weeks before the first dose; prior small-molecule targeted drugs with last dose less than 5 half-lives or 4 weeks (whichever is shorter) before the first dose; prior palliative radiotherapy or local therapy with completion less than 2 weeks before the first dose. 13. Pleural effusion, pericardial effusion, or ascites that cannot be controlled with appropriate interventions. 14. Severe infection within 1 month before the first dose, including but not limited to infectious complications requiring hospitalization, bacteremia, or severe pneumonia. 15. Concurrent or previous other malignancies, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, and other malignancies that have been adequately treated and cured for ≥3 years with documented evidence of no recurrence or metastasis. 16. History of immunodeficiency (including HIV-positive test), other acquired or congenital immunodeficiency diseases, or history of organ transplantation; known active hepatitis B (defined as HBsAg-positive with HBV DNA ≥500 IU/mL \[or ≥2500 copies/mL if the study site only uses copies/mL, in which case the subject is not eligible\]) or active hepatitis C (defined as positive hepatitis C virus antibody \[HCV-Ab\] and positive HCV-RNA at screening). 17. Any clinical or laboratory abnormality or other reason that, in the investigator's opinion, makes the subject unsuitable for participation in this clinical study.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
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Other studies related to the condition(s) this trial covers.
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