ClinicalTrials.gg
Not yet recruitingNCT07934121MISOUpdated Nov 12, 2026

MIRV in Combination With Suvemcitug for Partially Platinum-Sensitive Ovarian Cancer

A Phase 2 interventional study of Mirvetuximab Soravtansine and Suvemcitug in Platinum-Sensitive Recurrent Ovarian Cancer, sponsored by Tongji Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Tongji Hospital · Phase 2, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 15 studies in Ovarian Neoplasms by Tongji Hospital — 9 open to participants now, 11 under way, 2 of them phase 3. Ovarian Neoplasms · Tongji Hospital.

Started
2026
with 1 other
Phase 2
3 of 15
1 open now
Primary completion
2028-06
later than 4 of 10 live
Registered
15th of 15
by date

Among the 15 studies in Ovarian Neoplasms by Tongji Hospital, this one is one of 2 that started in 2026, is one of 3 in phase 2, reaches primary completion later than 4 of the 10 other live ones, and was the 15th registered.

Ovarian Neoplasms

3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.

Browse Ovarian Neoplasms studies →

Open to participants now

9 of the 15 studies in Ovarian Neoplasms by Tongji Hospital are open now, in 1 country. Recruiting first, the newest first:

3 more — sign in →

By country, each count listing its studies:

All 9 open studies →

Where they have run

Who these studies take

Of the 606 Ovarian Neoplasms studies recruiting now, 443 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

The full table on the hub →

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02

Study summary

This is a prospective, single-arm, phase II study designed to evaluate the efficacy and safety of mirvetuximab soravtansine combined with suvemcitug in patients with FRα-positive partially platinum-sensitive recurrent ovarian cancer.

Approximately 80 patients will be enrolled. Eligible patients must have recurrent high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with FRα expression and disease recurrence occurring 6 to 12 months after completion of platinum-based chemotherapy.

Participants will receive mirvetuximab soravtansine and suvemcitug every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. Tumor response will be assessed according to RECIST version 1.1.

The primary objective is to evaluate the objective response rate (ORR). Secondary objectives include duration of response (DOR), progression-free survival (PFS), overall survival (OS), CA125 response, and safety outcomes. Exploratory analyses will assess the relationship between FRα expression, other biomarkers, and clinical outcomes.

03

Conditions studied

  • Platinum-Sensitive Recurrent Ovarian Cancer

Browse trials for

Keywords

  • FRα
  • Mirvetuximab Soravtansine
  • Suvemcitug
  • ADC
  • VEGF
  • Ovarian Cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed written and able to comply with the protocol-specified visits and related procedures.
  2. Female patients aged ≥18 years.
  3. Patients with or cytologically confirmed high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
  4. Recurrence after prior standard platinum-based chemotherapy with or without bevacizumab ± PARP inhibitor, with the date of diagnosis of recurrence being 6-12 months from the last platinum-based chemotherapy.
  5. Patients with a BRCA mutation must have received PARP inhibitor therapy.
  6. Patients must have experienced disease progression during or after the most recent anticancer therapy received.
  7. Tumor FRα expression has been determined by the VENTANA FOLR1 assay to be ≥25% (requiring ≥25% of tumor cells with staining intensity ≥2+ after FRα staining).
  8. Patients must provide archived tumor tissue block or sections for central laboratory FRα testing and exploratory biomarker analysis. Tissue wax blocks are preferred; if wax blocks cannot be provided, no fewer than 10 unstained sections should be provided.
  9. Patients must have at least one evaluable lesion per v1.1 (determined by the investigator via imaging).
  10. performance status (ECOG PS) must be 0-2.
  11. Patients must have received at least 1 but no more than 2 lines of prior systemic anticancer chemotherapy:

    1. therapy ± adjuvant therapy is considered as 1 ;
    2. A change in treatment due to toxicity in the absence of disease progression is considered part of the same line of therapy (i.e., not counted separately).
  12. Adequate major organ function, and the patient is considered by the investigator to be suitable for treatment with mirvetuximab soravtansine combined with suvemcitug, defined as:

    1. (ANC) ≥1.5 × 10\^9/L (1,500/μL), and no use of G-CSF within the prior 10 days, or no use of long-acting WBC growth factors within the prior 20 days;
    2. count ≥100 × 10\^9/L (100,000/μL) with no platelet transfusion within the prior 10 days;
    3. ≥9.0 g/dL with no packed red blood cell (PRBC) transfusion within the prior 21 days;
    4. Serum creatinine ≤1.5 × (ULN);
    5. (AST) and alanine aminotransferase (ALT) ≤3.0 × ULN;
    6. Serum ≤1.5 × ULN (patients with Gilbert's syndrome may be enrolled if total bilirubin \<3.0 × ULN);
    7. Serum albumin ≥2 g/dL.
  13. All toxicities related to prior treatment (except alopecia) must have recovered to ≤ Grade 1 per v5.0.
  14. Any major surgery the patient has undergone must have been completed at least 4 weeks prior to the first dose of mirvetuximab soravtansine and suvemcitug, and postoperative complications from prior surgical treatment must have resolved or be stable.
  15. The subject's is assessed by the investigator to be at least 12 weeks.

Exclusion criteria

Exclusion Criteria:

  1. Concurrent participation in another clinical study.
  2. Patients with endometrioid, clear cell, mucinous, or sarcoma histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian tumors.
  3. Patients whom the investigator considers to have other serious systemic diseases (including active infection, non-infectious interstitial lung disease, cardiovascular or cerebrovascular disease within 6 months prior to the first dose, etc.) or other reasons that make them unsuitable for participation in this clinical study.
  4. Known prior to monoclonal antibody therapy or maytansinoids, or to the study drug and/or any of its .
  5. Patients with active or chronic corneal disease, history of corneal transplant, or active eye disease requiring continuous treatment/monitoring, for example: uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injection therapy, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and/or monocular vision.
  6. Patients with pleural effusion, pericardial effusion, or ascites that cannot be controlled by drainage or other methods should be excluded, except for small amounts of fluid that are asymptomatic or do not require clinical intervention.
  7. Patients who have previously received mirvetuximab soravtansine or other FRα-targeted therapies.
  8. Known active central nervous system (CNS) and/or . Subjects with untreated but asymptomatic , or those with imaging evidence of sustained progression-free status for at least 4 weeks after treatment and no need for hormones or anti-epileptic therapy for at least 2 weeks, may be considered for enrollment.
  9. Pregnant or breastfeeding women. Women of must agree to take highly effective measures during the study drug period and for at least 7 months after the last dose of study drug. Women of childbearing potential are defined as fertile women from menarche until menopause, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
  10. Patients who have received anti-tumor therapy or participated in a clinical study and received an drug within 2 weeks prior to the first dose of this study.
  11. Patients with hypertension that cannot be reduced to the normal range with antihypertensive medication (systolic blood pressure > 150 mmHg, diastolic blood pressure > 90 mmHg).
  12. Patients with Class III-IV cardiac insufficiency, or (LVEF) \< 50% as indicated by echocardiography
  13. Patients with proteinuria (urine protein > 1+ found during screening; or urine protein 1+ that does not return to normal upon repeat testing within 24 hours);
  14. Patients with a clear tendency for gastrointestinal bleeding, including the following conditions: presence of a local active ulcer lesion with fecal occult blood (++) making them ineligible for enrollment; history of melena or hematemesis within 2 months; presence of high bleeding risk: Grade ≥ 3 bleeding events within the past 6 months, hemoptysis ≥ 2.5 mL per episode; imaging suggesting tumor erosion into major blood vessels; or investigator judgment that the bleeding risk is unacceptable;
  15. Presence of high risk of gastrointestinal perforation/fistula: gastrointestinal perforation or active peptic ulcer within the past 6 months; or pelvic tumor significantly invading the bladder/rectum with potential risk of fistula (investigator judgment);
  16. Coagulation abnormalities ( > 1.5, APTT > 1.5 × ) with a bleeding tendency;
  17. Long-term unhealed wounds or fractures; major surgery or severe traumatic injury, fracture, or ulcer within 4 weeks.
Terms in these criteria, in plain language(26)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Mirvetuximab Soravtansine + Suvemcitug

    Patients with FRα-expressing partially platinum-sensitive recurrent ovarian cancer will receive mirvetuximab soravtansine combined with suvemcitug. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, death, or other protocol-specified discontinuation criteria.

    Drug: Mirvetuximab Soravtansine · Drug: Suvemcitug

Interventions

  • DrugMirvetuximab Soravtansine

    Mirvetuximab soravtansine is a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC) consisting of a humanized monoclonal antibody linked to the maytansinoid DM4. It is administered intravenously in combination with suvemcitug for the treatment of patients with FRα-expressing partially platinum-sensitive recurrent ovarian cancer.

  • DrugSuvemcitug

    Suvemcitug is a recombinant humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF). In this study, suvemcitug is administered intravenously in combination with mirvetuximab soravtansine to evaluate the efficacy and safety in patients with FRα-expressing partially platinum-sensitive recurrent ovarian cancer.

06

What researchers measure

Primary outcomes

  1. Overall Response Rate(ORR)

    Investigator-assessed ORR, including confirmed best overall response of CR or PR per RECIST v1.1.

    Time frame: up to 24 months

Secondary outcomes

  1. Progression-Free Survival(PFS)

    Investigator-assessed PFS: Defined as the time from first dose to the first documented PD per tumor assessment follow-up or death from any cause (whichever occurs first).

    Time frame: up to 24 months

  2. During of response*(DoR)

    Investigator-assessed DOR: For patients who achieve an objective response, DOR is defined as the time from first meeting CR/PR criteria (whichever occurs first) to the date of PD or death from any cause (whichever occurs first).

    Time frame: up to 24 months

  3. Overall Survival (OS)

    OS: Defined as the time from first dose to death from any cause (for patients lost to follow-up prior to death, the last follow-up date is typically used as the date of death).

    Time frame: up to 24 months

  4. CA125 response

    CA125 response: Assessed according to GCIG (Gynecologic Cancer InterGroup) criteria. In the GCIG CA125 criteria, CA125 response is defined as a reduction in CA125 level of at least 50% after treatment, maintained for at least 28 days. CA125 assessment can only be performed if the patient's CA125 level is greater than twice the upper limit of normal within the 2 weeks before the start of treatment.

    Time frame: up to 24 months

  5. Incidence, severity, and duration of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs). (Assessed by the investigator per CTCAE criteria.)

    Time frame: up to 24 months

  6. Incidence of Grade ≥3 treatment-related adverse events (TRAEs) assessed by the investigator. (Assessed by the investigator per CTCAE criteria.)

    Time frame: up to 24 months

Other outcomes

  1. Correlation between baseline tumor tissue FRα expression levels and other exploratory biomarker characteristics with ORR, PFS, DOR, and treatment-related adverse events.

    Time frame: up to 24 months

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Jun 2028, 19 months later.

Of 228 non-industry phase 2 interventional studies under Ovarian Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 80. This study's planned 19 months is below that.

Counting every sponsor, half of 344 studies reached it within 47 months; a quarter within 33 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2026
First posted
Nov 12, 2026
StartEst.
Nov 10, 2026
Primary completionEst.
Jun 30, 2028
CompletionEst.
Jun 30, 2028
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07934121
Lead sponsor
Tongji Hospital
Responsible party
Qinglei Gao (Professor, Tongji Hospital) — Principal investigator
First posted
Nov 12, 2026
Start date
Nov 10, 2026 (estimated)
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Nov 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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