New drug duo aims to outperform chemo in ovarian cancer

NCT ID NCT07684612

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Sep 04, 2026 · Updated 5 times

Summary

This phase 3 trial tests whether a new drug called mocertatug rezetecan (Mo-Rez) combined with bevacizumab works better than standard chemotherapy plus bevacizumab for women with platinum-sensitive ovarian cancer. The study includes about 690 participants whose cancer has returned after initial treatment. Researchers will measure how long the cancer stays under control and whether the new combination helps women live longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mocertatug rezetecan (Mo-Rez) plus bevacizumab
What this could lead to
If it works, this could offer a new, more effective treatment option for women with platinum-sensitive ovarian cancer, potentially shrinking tumors and extending life.
What could go wrong
This is an early-phase 3 trial, so results are not guaranteed. The new drug may cause unexpected side effects or not work better than standard chemotherapy.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 690 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Apr 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Is at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed Consent Form (ICF). * Has epithelial ovarian, primary peritoneal, or fallopian-tube cancer with a histologically confirmed diagnosis of high grade serous, high grade endometrioid, clear cell carcinoma, or carcinosarcoma. * Has recurrent or progressive disease after completion of at least 1 and a maximum of 2 previous lines of systemic anticancer therapy. Recurrent or progressive disease should be determined based on radiographic assessment according to RECIST 1.1 per investigator and/or clinical assessment of disease progression by investigator. Prior lines of therapy are defined as follows: * Adjuvant ± neoadjuvant is considered one line of therapy. * Maintenance therapy (e.g., bevacizumab, Poly ADP-ribose polymerase inhibitor \[PARPi\]) will be considered as part of the preceding line of therapy (i.e., not counted independently). * Therapy changed to another agent in the same class due to toxicity, in the absence of progression, will be considered as part of the same line (i.e., not counted independently). * Unplanned addition or switching to a new drug in a different class is considered a separate line of therapy * Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance. * Has platinum-sensitive disease and is suitable for platinum doublet chemotherapy with bevacizumab for the treatment of recurrent disease. Platinum sensitive disease is defined as recurrent or progressive disease \>6 months after last dose of platinum-based chemotherapy. * Has documented results of local testing (compliant to local regulations) for tumor and/or germline Breast Cancer Gene (BRCA1 and BRCA2) mutation. Participants with a known tumor or germline deleterious BRCA1 or BRCA2 mutation must have previously received PARPi maintenance therapy, alone or in combination with bevacizumab, if the participant was considered a candidate for this treatment and the treatment is locally available. * Has provided a Formalin Fixed Paraffin Embedded (FFPE) tumor tissue sample sufficient for the central assessment of B7 homolog 4 protein (B7-H4) expression, with the result of B7-H4 expression testing available prior to the date of randomization. * Is willing to use adequate contraception. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * A female participant is eligible to participate if they are not pregnant or breastfeeding, and 1 of the following conditions applies: * Is a Participant of Non-Childbearing Potential (PONCBP). OR * Is a Participant of Childbearing Potential (POCBP) and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency, 30 days prior to Cycle 1 Day 1 (C1D1) and during the study intervention period and for at least 8 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention. * A POCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention. * Is capable of giving signed informed consent including compliance with the requirements and restrictions listed in the ICF and in this protocol. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Has adequate organ function. Exclusion Criteria: * Plans to undergo interval secondary cytoreductive surgery for recurrent PSOC during induction therapy (platinum doublet and bevacizumab). * Has a malignancy (except disease under study) that has progressed or required active treatment within the past 36 months prior to the date of randomization, except for basal cell or squamous cell carcinomas of the skin or in situ carcinomas (e.g., breast, cervix, bladder) that have been resected with no evidence of metastatic disease, or that is otherwise considered cured by the investigator. * Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study. * Has untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed (e.g., evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain/CNS metastases). Participants with previously treated and clinically stable brain/CNS metastases and who have completed all corticosteroid therapy for ≥14 days prior to the date of C1D1 are not excluded from participation. * Has any evidence of current Interstitial Lung Disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis. * Has ongoing adverse reaction(s) from prior therapy that has (have) not recovered to Grade ≤1 or to the baseline status preceding prior therapy, excluding alopecia, hearing loss, vitiligo, endocrinopathy managed with replacement therapy, Grade 2 neuropathy or that the investigator, with the agreement of the sponsor, considers to be not clinically relevant for the tolerability of study intervention in the current clinical study. * Has any serious and/or unstable medical condition (including infection) or any serious and/or unstable psychiatric disorder or other condition(s) (including laboratory assessment abnormalities) that could interfere with the participant's safety, obtainment of informed consent, or compliance to the study procedures. * Has clinically significant wound healing complications or incompletely healed wounds. * Has a history or evidence of gastrointestinal perforation, tracheoesophageal fistula, or any Grade 4 fistula; has gastrointestinal fistula, visceral fistula, or abdominal abscess within 6 months prior to the date of C1D1; has osteonecrosis of the jaw. * Has evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on computed tomography (CT) scan or clinical symptoms of bowel obstruction. * Has clinically significant bleeding symptoms, significant bleeding tendency, or bleeding tumors within 30 days prior to the date of C1D1. * Has congenital bleeding diathesis, acquired coagulopathy, recent pulmonary hemorrhage/hemoptysis (\>2.5 mL of red blood or a half teaspoon) within 3 months prior to the date of C1D1. * Has had any major surgery within 28 days prior to the date of C1D1 or history of focal radiotherapy within 21 days prior to the date of C1D1. * Has received treatment with an investigational agent within 30 days prior to the date of C1D1. * Has ever received prior therapy with topoisomerase 1 inhibitor \[Topo1i\] (e.g., topotecan) or antibody-Drug Conjugate (ADC) with a Topo1i warhead, or B7-H4 targeted therapy. * Has received treatment with any cytotoxic chemotherapy drugs or other antitumor drugs (including endocrine therapy, molecular targeted therapy, immunotherapy or biotherapy) within 30 days or 5 half-lives, whichever is shorter, prior to the date of C1D1; or need to continue these drugs during study participation. * Has received treatment with inhibitors of P-glycoprotein (P-gp), or Breast Cancer Resistant Protein (BCRP), or Organic Anion Transporting Polypeptides 1B1/1B3 (OATP1B1/1B3) within 7 days prior to the date of C1D1. Has received treatment with inducers of P-gp within 14 days prior to the date of C1D1. * Has received any live vaccine within 30 days prior to the date of C1D1. * Has received any transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 14 days prior to date of C1D1. * Has a history within 12 months prior to screening of clinically significant or uncontrolled cardiac disease, acute myocardial infarction, New York Heart Association Class III or IV congestive heart failure, or clinically significant arrhythmia not controlled by standard of care therapy. * Has baseline Left Ventricular Ejection Fraction (LVEF) \<50% or less than institutional lower limit of normal. * Has clinically significant abnormal blood pressure according to investigator assessment, or inadequately treated and uncontrolled hypertension including history of hypertensive crisis; hypertensive encephalopathy; or adjustment of antihypertensive medications due to poor blood pressure control within 14 days prior to the date of C1D1. * Has a history of nephrotic syndrome or Grade 3 proteinuria. * Meets the following criteria for proteinuria during screening assessments: ≥2+ proteinuria on urine dipstick and 24-hour urine collection demonstrating ≥1 g of urine protein in 24 hours.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • GSK Investigational Site

    Hokkaido, 003-0804, Japan

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