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PROCPhase 2NCT07741630

Mirvetuximab Soravtansine Combined With Suvemcitug in Platinum-Resistant Recurrent Ovarian Cancer

A Phase 2 study testing Mirvetuximab soravtansine and Suvemcitug in people with PROC, run by Peking University Third Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

his is an open-label, single-center, single-arm, prospective Phase II trial evaluating the efficacy and safety of Mirvetuximab Soravtansine (MIRV) combined with Suvemcitug (SV) in patients with folate receptor alpha (FRα)-positive, platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
PROC
What is being tested?
Mirvetuximab soravtansine and Suvemcitug
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
15 Aug 2026to 30 Apr 2028
Phase
Phase 2
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

  • Voluntary written informed consent signed prior to any study-related procedures.
  • Female age ≥ 18 years at the time of signing informed consent.
  • Histologically confirmed high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
  • Documented platinum-resistant recurrence, defined as progression within 6 months after completion of the last platinum-based chemotherapy regimen (excluding primary platinum-refractory disease, defined as progression during or within 3 months of first-line platinum-based therapy).
  • Radiologically confirmed disease progression during or following the most recent line of therapy.
  • FRα-positive tumor status verified by the Ventana FOLR1 (FOLR-2.1) CDx IHC assay, defined as ≥25% of tumor cells showing ≥2+ membrane staining intensity.
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  • Presence of at least one measurable lesion according to RECIST v1.1 guidelines as evaluated by investigator imaging.
  • Must have received 1 to 3 prior systemic antineoplastic therapy lines.
  • Must have received prior treatment with bevacizumab.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate washout period from prior antineoplastic therapy: ≥5 half-lives or ≥4 weeks for systemic therapy (whichever is shorter); ≥2 weeks for localized palliative radiotherapy.
  • Recovery or stabilization of all toxicities from prior therapies to Grade ≤1 or baseline (NCI CTCAE v5.0).
  • Major surgery completed at least 4 weeks prior to initiation of study treatment, with postoperative toxicities recovered or stabilized.
  • Adequate bone marrow, hepatic, and renal organ functions.

Who cannot join

  • Non-serous histological subtypes, including endometrioid, clear cell, mucinous, sarcomatous components, mixed histology containing any of these components, or low-grade/borderline ovarian tumors.
  • Primary platinum-refractory disease (failure to achieve CR/PR to first-line platinum therapy or progression within 3 months after last platinum dose).
  • Prior wide-field radiation therapy involving ≥20% of bone marrow.
  • Baseline peripheral neuropathy > Grade 1 according to CTCAE v5.0.
  • Active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing medication/monitoring (e.g., uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic macular edema, macular degeneration, papilledema, and/or monocular vision).
  • History of multiple sclerosis, other demyelinating diseases, or Lambert-Eaton myasthenic syndrome.
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  • Uncontrolled severe systemic comorbid conditions (e.g., active infection, non-infectious interstitial lung disease, or clinically significant cardiovascular/cerebrovascular events within 6 months prior to first dose) rendering the patient unsuitable for the study.
  • History of hemorrhagic or ischemic stroke within 6 months prior to randomization/enrollment.
  • History of hepatic cirrhosis (Child-Pugh Class B or C).
  • History of bowel obstruction (including subileus) related to underlying disease within 6 months prior to study initiation.
  • Presence of any of the following:
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess;
  • Pelvic examination or CT scan indicating rectosigmoid/gastrointestinal involvement, or clinical signs/symptoms of intestinal obstruction.
  • Non-healing wounds, active ulcers, or bone fractures.
  • Hemoptysis (≥0.5 teaspoon / ~2.5 mL of fresh red blood per episode) within 4 weeks prior to first dose.
  • History of Posterior Reversible Encephalopathy Syndrome (PRES).
  • Clinically significant proteinuria: Urine Protein/Creatinine Ratio (UPC) ≥ 1.0 or dipstick protein ≥ 2+; if UPC ≥ 1.0 or dipstick ≥ 2+, 24-hour urine protein quantification must be ≤ 1.0 g/24h to be eligible.
  • History of pulmonary embolism.
  • History of Grade 4 thromboembolic events.
  • Prior treatment with mirvetuximab soravtansine, other FRα-targeting agents, or suvemcitug.
  • Untreated or symptomatic central nervous system (CNS) metastases.
  • Malignancy within 3 years prior to enrollment, except for localized cancers treated with curative intent with negligible risk of metastasis or death (e.g., adequately treated basal cell/squamous cell skin cancer or carcinoma in situ of the cervix/breast).
  • Pregnant or breastfeeding females.
  • Known hypersensitivity to any of the study intervention drugs or excipients.
  • Any other condition that, in the opinion of the investigator, makes the patient unsuitable for trial participation.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Hongyan Guo, MD contact

+86-010-82266699

bysyghy@163.com

About this study

his is an open-label, single-center, single-arm, prospective Phase II trial evaluating the efficacy and safety of Mirvetuximab Soravtansine (MIRV) combined with Suvemcitug (SV) in patients with folate receptor alpha (FRα)-positive, platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. A total of 20 eligible patients will receive MIRV (6 mg/kg AIBW IV Q3W) and Suvemcitug (1.5 mg/kg IV Q2W) until disease progression or intolerable toxicity. The primary endpoint is investigator-assessed Progression-Free Survival (PFS) per RECIST v1.1.

Conditions
PROC
Being tested
Mirvetuximab soravtansine, Suvemcitug

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mirvetuximab soravtansineDrug

    Also called Mirv

    6 mg/kg adjusted ideal body weight (AIBW), administered intravenously (IV) once every 3 weeks (Q3W).

  • SuvemcitugDrug

    1.5 mg/kg, administered intravenously (IV) once every 2 weeks (Q2W).

Study groups in NCT07741630
Study groupRoleWhat they receive
Experimental ArmExperimentalNot described
Receives: Drug: Mirvetuximab soravtansine; Drug: Suvemcitug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from the date of the first dose of study treatment until the date of first documented radiological disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause, whichever occurs first.

    Measured: Up to approximately 20 months (assessed every 6-8 weeks during treatment).

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    Defined as the proportion of participants who achieve a confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) assessed by the investigator according to RECIST v1.1. Confirmation of response is required at least 4 weeks after initial criteria for response are met.

    Measured: Up to approximately 20 months.

  2. Duration of Response (DOR)

    Defined as the time from the initial documentation of confirmed objective response (CR or PR) to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.

    Measured: Up to approximately 20 months.

  3. Overall Survival (OS)

    Defined as the time from the date of the first dose of study treatment until the date of death from any cause.

    Measured: Up to approximately 20 months (survival follow-up every 3 months after treatment discontinuation until EOS).

  4. Incidence of Adverse Events

    Incidence, severity, and resolution of Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events (TRAEs), and Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

    Measured: From baseline (ICD signing) up to 30 days after the last dose of study treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2026
  2. Study start15 Aug 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07741630
Sponsor's protocol ID
M20260303
Status last verified
Jul 2026
First submitted
29 Jul 2026
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mirvetuximab soravtansine and Suvemcitug in people with PROC, run by Peking University Third Hospital.

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 14 inclusion and 25 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 3 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Hongyan Guo, MD (+86-010-82266699, bysyghy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Up to approximately 20 months (assessed every 6-8 weeks during treatment).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07741630.

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 3 Aug 2026.

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