Epithelial Ovarian CancerEarly Phase 1NCT07790939
89Zr-DFO-Mirvetuximab PET/CT Imaging for Companion Diagnosis and Response Evaluation in Ovarian Cancer
A Early Phase 1 study testing 89Zr-DFO-Mirvetuximab PET/CT in people with Epithelial Ovarian Cancer and Ovarian Cancer, run by Peking University Cancer Hospital & Institute.
Trial summary
Epithelial ovarian cancer (EOC) is the fifth leading cause of cancer-related death in women, with approximately 320,000 new cases and 200,000 deaths annually worldwide, and its incidence is rising. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Ovarian Cancer
- What is being tested?
- 89Zr-DFO-Mirvetuximab PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2027
- Phase
- Early Phase 1
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly diagnosed stage IV ovarian cancer or first-recurrent ovarian cancer, aged >18 years.
- No clinically significant abnormalities in complete blood count, liver function, or renal function.
- Estimated life expectancy ≥6 months.
- At least one measurable target lesion per RECIST version 1.1.
- Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days prior to the start of the study procedures; patients with reproductive potential must agree to use effective contraception to avoid pregnancy during the study and within 3 months after the last imaging examination.
- Female patients must adopt effective contraceptive measures throughout the study period and for 6 months after study completion.
- Patients must fully understand and voluntarily participate in the trial, and provide written informed consent.
Who cannot join
- Severe hepatic or renal dysfunction.
- Women who are planning pregnancy, pregnant, or breastfeeding.
- Inability to remain supine for 30 minutes.
- Inability to provide informed consent.
- Claustrophobia or other psychiatric disorders.
- Known allergy to the investigational drug or its excipients.
- Any other condition that the investigator deems unsuitable for participation in the trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Epithelial ovarian cancer (EOC) is the fifth leading cause of cancer-related death in women, with approximately 320,000 new cases and 200,000 deaths annually worldwide, and its incidence is rising. Current treatment mainly relies on surgery, chemotherapy, and radiotherapy, but EOC frequently develops platinum resistance and recurrence. Mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), was approved by the FDA in 2024 for FRα-positive, platinum-resistant EOC. However, it carries significant toxicities (ocular, interstitial lung disease, peripheral neuropathy) and a modest objective response rate of 33%, with rapid acquired resistance, underscoring the need for patient selection and response prediction via targeted imaging. FRα, a GPI-anchored cell-surface glycoprotein encoded by FOLR1, is minimally expressed in normal adult tissues but overexpressed in various epithelial tumors, including ovarian cancer. Its overexpression promotes invasion, metastasis, and potentially drug resistance, making it a promising theranostic target. While ¹⁸F-FDG PET/CT is widely used, it has limitations in detecting low-activity or small lesions and shows suboptimal sensitivity/specificity for nodal metastases. Radiolabeled folate probes (e.g., ⁹⁹ᵐTc-EC20) have demonstrated excellent FRα-targeting and clinical utility in selecting patients for FRα-directed therapies. Our team has developed ⁸⁹Zr-DFO-Mirvetuximab by conjugating the anti-FRα monoclonal antibody with the chelator p-isothiocyanatobenzyl-desferrioxamine B and radiolabeling with ⁸⁹Zr. Preclinically, this probe exhibited favorable stability, safety, and specific targeting of FRα-high tumors in xenograft models. Building on these results, we plan a clinical study enrolling 20 patients with newly diagnosed stage IV or first-recurrent EOC, who will undergo both ⁸⁹Zr-DFO-Mirvetuximab PET/CT and ¹⁸F-FDG PET/CT. The study aims to correlate radiotracer uptake with FRα expression and to demonstrate the superior performance of ⁸⁹Zr-DFO-Mirvetuximab in identifying and delineating ovarian cancer lesions compared to ¹⁸F-FDG
- Conditions
- Epithelial Ovarian Cancer, Ovarian Cancer
- Being tested
- 89Zr-DFO-Mirvetuximab PET/CT
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-DFO-Mirvetuximab PET/CTOther
Two weeks prior to the start of the trial, laboratory test results including complete blood count, urinalysis, blood biochemistry, and electrocardiogram, as well as imaging findings, will be collected. Within one week after trial initiation, one ¹⁸F-FDG PET scan (at 1 h post-injection) and three ⁸⁹Zr-DFO-Mirvetuximab PET scans (at 24 h, 72 h, and 144 h post-injection) will be performed. Two months after trial completion, pathological examination results will be obtained and compared with the PET imaging findings
| Study group | Role | What they receive |
|---|---|---|
| 89Zr-DFO-Mirvetuximab PET/CT for Companion Diagnosis and Response Evaluation | Experimental | Not described Receives: Other: 89Zr-DFO-Mirvetuximab PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Uptake Value (SUV) of target or suspected tumor lesions in ovarian tumor for 89Zr-DFO-Mirvetuximab and 18F-FDG across imaging time points
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Zhu, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790939
- Sponsor's protocol ID
- 2026YJZ85
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 89Zr-DFO-Mirvetuximab PET/CT Imaging for Companion Diagnosis and Response Evaluation in Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07790939
- Acronym / sponsor ID
- 2026YJZ85
- Conditions
- Epithelial Ovarian Cancer, Ovarian Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 27 Aug 2026 (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.
Epithelial ovarian cancer (EOC) is the fifth leading cause of cancer-related death in women, with approximately 320,000 new cases and 200,000 deaths annually worldwide, and its incidence is rising. Current treatment mainly relies on surgery, chemotherapy, and radiotherapy, but EOC frequently develops platinum resistance and recurrence. Mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), was approved by the FDA in 2024 for FRα-positive, platinum-resistant EOC. However, it carries significant toxicities (ocular, interstitial lung disease, peripheral neuropathy) and a modest objective response rate of 33%, with rapid acquired resistance, underscoring the need for patient selection and response prediction via targeted imaging. FRα, a GPI-anchored cell-surface glycoprotein encoded by FOLR1, is minimally expressed in normal adult tissues but overexpressed in various epithelial tumors, including ovarian cancer. Its overexpression promotes invasion, metastasis, and potentially drug resistance, making it a promising theranostic target. While ¹⁸F-FDG PET/CT is widely used, it has limitations in detecting low-activity or small lesions and shows suboptimal sensitivity/specificity for nodal metastases. Radiolabeled folate probes (e.g., ⁹⁹ᵐTc-EC20) have demonstrated excellent FRα-targeting and clinical utility in selecting patients for FRα-directed therapies. Our team has developed ⁸⁹Zr-DFO-Mirvetuximab by conjugating the anti-FRα monoclonal antibody with the chelator p-isothiocyanatobenzyl-desferrioxamine B and radiolabeling with ⁸⁹Zr. Preclinically, this probe exhibited favorable stability, safety, and specific targeting of FRα-high tumors in xenograft models. Building on these results, we plan a clinical study enrolling 20 patients with newly diagnosed stage IV or first-recurrent EOC, who will undergo both ⁸⁹Zr-DFO-Mirvetuximab PET/CT and ¹⁸F-FDG PET/CT. The study aims to correlate radiotracer uptake with FRα expression and to demonstrate the superior performance of ⁸⁹Zr-DFO-Mirvetuximab in identifying and delineating ovarian cancer lesions compared to ¹⁸F-FDG
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 89Zr-DFO-Mirvetuximab PET/CT for Companion Diagnosis and Response Evaluation | Experimental | Other: 89Zr-DFO-Mirvetuximab PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with newly diagnosed stage IV ovarian cancer or first-recurrent ovarian cancer, aged >18 years.
- No clinically significant abnormalities in complete blood count, liver function, or renal function.
- Estimated life expectancy ≥6 months.
- At least one measurable target lesion per RECIST version 1.1.
- Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days prior to the start of the study procedures; patients with reproductive potential must agree to use effective contraception to avoid pregnancy during the study and within 3 months after the last imaging examination.
Key exclusion criteria (7 listed)
- Severe hepatic or renal dysfunction.
- Women who are planning pregnancy, pregnant, or breastfeeding.
- Inability to remain supine for 30 minutes.
- Inability to provide informed consent.
- Claustrophobia or other psychiatric disorders.
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 |
|---|---|---|
| 89Zr-DFO-Mirvetuximab PET/CTTwo weeks prior to the start of the trial, laboratory test results including complete blood count, urinalysis, blood biochemistry, and electrocardiogram, as well as imaging findings, will be collected. Within one week after trial initiation, one ¹⁸F-FDG PET scan (at 1 h post-injection) and three ⁸⁹Zr-DFO-Mirvetuximab PET scans (at 24 h, 72 h, and 144 h post-injection) will be performed. Two months after trial completion, pathological examination results will be obtained and compared with the PET imaging findings | Other | 89Zr-DFO-Mirvetuximab PET/CT for Companion Diagnosis and Response Evaluation |
Primary outcome
Standardized Uptake Value (SUV) of target or suspected tumor lesions in ovarian tumor for 89Zr-DFO-Mirvetuximab and 18F-FDG across imaging time points
Time frame: 1 week
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 27 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 89Zr-DFO-Mirvetuximab PET/CT in people with Epithelial Ovarian Cancer and Ovarian Cancer, run by Peking University Cancer Hospital & Institute.
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 7 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: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 杨 楠 (18004010562, yangnan200006@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized Uptake Value (SUV) of target or suspected tumor lesions in ovarian tumor for 89Zr-DFO-Mirvetuximab and 18F-FDG across imaging time points (time frame: 1 week). 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 27 Aug 2026.