Can a Two-Drug combo outsmart resistant ovarian cancer?
NCT ID NCT07741630
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether combining two drugs—mirvetuximab soravtansine and suvemcitug—can help people with a type of ovarian cancer that has stopped responding to platinum-based chemotherapy. The study will enroll 20 adults with FRα-positive, platinum-resistant recurrent ovarian, fallopian tube, or primary peritoneal cancer. Participants will receive both drugs intravenously until their disease progresses or side effects become intolerable. The main goal is to see how long the treatment can keep the cancer from growing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Mirvetuximab soravtansine combined with suvemcitug
- What this could lead to
- If successful, this combination could offer a new treatment option for people with platinum-resistant ovarian cancer, potentially slowing tumor growth and improving outcomes.
- What could go wrong
- This is a small, early-phase trial, so results may not be conclusive. The combination may cause side effects or may not work better than existing treatments.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 years and older
- 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: \- 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. Exclusion Criteria: \- 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. 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.
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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 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.
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