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

NCT07741630 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: M20260303
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Up to approximately 20 months.

• Duration of Response (DOR)

  Up to approximately 20 months.

• Overall Survival (OS)

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

• Incidence of Adverse Events

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

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Drug: Mirvetuximab soravtansine; Drug: Suvemcitug

Interventions

Mirvetuximab soravtansine DRUG

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

Also known as: Mirv

Experimental Arm

Suvemcitug DRUG

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

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• 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.

You may not qualify if:

• \- 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.
• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Interventions

mirvetuximab soravtansine

Central Study Contacts

Hongyan Guo, MD

CONTACT

+86-010-82266699; bysyghy@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share