Targeted Antibody-Drug could shrink Hard-to-Treat ovarian cancers
NCT ID NCT07674615
First seen Jun 29, 2026 · Last updated Jul 01, 2026 · Updated 2 times
Summary
This trial tests a drug called sacituzumab govitecan in people with advanced or recurrent ovarian, fallopian tube, or primary peritoneal cancer that has high levels of a protein called TROP-2. Participants must have already tried standard treatments without success. The drug is given by IV on days 1 and 8 of each 21-day cycle. The main goal is to see how many patients have their tumors shrink or disappear.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sacituzumab govitecan
- What this could lead to
- If effective, this could offer a new treatment option for people with advanced ovarian cancer that has stopped responding to standard therapies.
- What could go wrong
- This is an early-phase trial with only 19 participants, so results may not apply broadly. The drug may cause side effects or fail to shrink tumors.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 19 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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 80 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: * Age ≥ 18 years and ≤ 80 years; * Histologically confirmed advanced or recurrent high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer; * Recurrent patients meeting one of the following two conditions: Disease recurrence or progression after at least one prior platinum-based chemotherapy regimen, with disease progression occurring less than 6 months from the last dose of platinum-based chemotherapy; * Disease recurrence or progression after at least three prior platinum-based chemotherapy regimens, with disease progression occurring ≥ 6 months from the last dose of platinum-based chemotherapy, and who are unable to receive standard platinum-based chemotherapy; * Patients with advanced epithelial ovarian cancer presenting with hematogenous metastasis, who are unable to receive standard treatment, with an estimated life expectancy of more than 3 months but approximately not exceeding 12 months with current therapy; * Have measurable disease per RECIST 1.1 criteria (Appendix A) or diagnosis of recurrence/disease progression per GCIG criteria; * Known BRCA (Breast Cancer Gene) and HRD (Homologous Recombination Deficiency) status; * Have available paraffin-embedded or fresh tumor tissue for TROP-2 testing; * Tumor tissue TROP-2 H-score \> 200; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; * Adequate bone marrow hematopoietic function and organ function, allowing the patient to receive treatment; * Patients must have had at least a 2-week interval from prior therapy (chemotherapy, investigational agents including small molecule inhibitors, endocrine therapy, immunotherapy, and/or radiotherapy) or major surgery; * Patients must have had at least a 2-week interval from high-dose systemic corticosteroids (however, low-dose corticosteroids \< 20 mg prednisone or its equivalent are permitted); * Patients must have recovered from acute toxicity due to prior therapy to Grade 1 or below; * Signed informed consent. Exclusion Criteria: * Patients who have previously received topoisomerase I inhibitor therapy; * Patients with known hypersensitivity to the study drug, its metabolites, or formulation excipients; * Patients requiring ongoing treatment or prior use of any prohibited medications (e.g., UGT1A1 inhibitors); * Patients with Gilbert's syndrome; * Patients with other uncontrolled malignancies concurrently or within 5 years, whose treatment would interfere with the current therapy for recurrent ovarian cancer or affect the prognosis of this treatment. Carcinoma in situ and breast cancer (without active disease or signs of recurrence) are excluded; * Patients with a history of clinically significant hemorrhage, bowel obstruction, or gastrointestinal perforation within 6 months prior to the start of study treatment, with an estimated life expectancy of less than 3 months; * Patients with a history of significant cardiac disease within 6 months, such as uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure (NYHA Class III-IV), or clinically significant arrhythmias requiring antiarrhythmic therapy (except stable atrial fibrillation); * Patients with known clinically significant active chronic obstructive pulmonary disease (COPD) or other moderate-to-severe chronic respiratory disease within 6 months; * Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose, have all neurological symptoms returned to baseline, have no evidence of new or enlarging brain metastases, and are on a daily dose of ≤ 20 mg prednisone or its equivalent. All patients with carcinomatous meningitis are excluded regardless of clinical stability; * Patients with uncontrolled seizure history or active neurologic disorders; Patients with known HIV-1 or HIV-2 (or HIV-1/2 antibody positive) with detectable viral load, or those taking medications that may interfere with SN-38 metabolism; * Patients with active HBV or HCV. For patients with a history of HBV or HCV, those with detectable viral load will be excluded; * Patients with known bleeding diathesis or active bleeding disorders; * Patients with active ≥ Grade 2 anorexia, nausea, or vomiting, and/or signs of bowel obstruction; * Patients with other concurrent medical or psychiatric conditions that, in the investigator's opinion, may confound study interpretation or prevent completion of study procedures and follow-up examinations; * Patients with any unstable medical problems (including the cardiac issues mentioned above, active treatment for symptomatic pulmonary embolism, stroke, renal or hepatic insufficiency, active infection/sepsis requiring intravenous antibiotics); * Any medical condition that, in the investigator's opinion, poses an undue risk to the patient's participation in the 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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Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, 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
- Mapping the DNA test that decides who gets PARP inhibitors
- Can inhaled manganese make ovarian cancer immunotherapy hit harder?
- Can a common cholesterol pill help chemotherapy fight ovarian cancer?
- Can a new drug combo keep ovarian cancer from coming back?