Mocertatug Rezetecan with Bevacizumab vs Platinum Doublet with Bevacizumab in Platinum-Sensitive Ovarian Cancer
Official title: A Randomized, Open-Label, Multicenter, Phase 3 Study to Investigate Mocertatug Rezetecan With Bevacizumab Compared With Platinum Doublet With Bevacizumab in Participants With Platinum-Sensitive Ovarian Cancer
Run by GlaxoSmithKline · NCT07684612 · Data updated 2026-11-12
This trial tests whether mocertatug rezetecan plus bevacizumab helps people with platinum-sensitive ovarian cancer respond better than standard platinum-based therapy plus bevacizumab.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 690 (estimated) |
| Sponsor | GlaxoSmithKline Industry-sponsored |
| Drugs / interventions | bevacizumab, chemotherapy, immunotherapy |
| Locations | 9 sites (Newcastle, New South Wales and 8 other locations) |
| Status | Recruiting |
| Started | September 8, 2026 |
| Main results expected | May 21, 2030 |
| Study ends | April 22, 2033 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT07684612 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with platinum-sensitive epithelial ovarian, primary peritoneal, or fallopian-tube cancer, histologies including high-grade serous/endometrioid/clear cell/carcinosarcoma, and 1-2 prior lines of therapy.
✕Probably not a fit
Patients whose disease does not respond to Mo-Rez or who experience intolerable safety issues may not receive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 3 interventional study comparing Mocertatug Rezetecan (Mo-Rez) in combination with bevacizumab to a platinum doublet regimen with bevacizumab in adults with platinum-sensitive ovarian cancer. Participants have epithelial ovarian, primary peritoneal, or fallopian-tube cancers with specific high-grade histologies and 1-2 prior systemic therapy lines. The study will evaluate tumor response, progression-free survival, overall survival, and safety/tolerability, to understand the potential benefits and main side effects of Mo-Rez with bevacizumab. Interventions include Mo-Rez with bevacizumab versus carboplatin-paclitaxel-gemcitabine or Mo-Rez-based regimens as clinically appropriate, with safety monitoring throughout.
Why it matters
Potential benefit: If successful, patients could experience larger or longer-lasting tumor shrinkage and improved survival with the Mo-Rez plus bevacizumab combination.
How similar studies have gone: Previous studies in similar targeted and anti-angiogenic combinations have shown mixed results; this study tests a novel Mo-Rez approach in this setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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GSK Investigational Site
Newcastle, New South Wales, Australia Recruiting -
GSK Investigational Site
Toronto, Ontario, Canada Recruiting -
GSK Investigational Site
Montreal, Quebec, Canada Recruiting -
GSK Investigational Site
Hokkaido, Japan Recruiting -
GSK Investigational Site
Hyōgo, Japan Recruiting -
GSK Investigational Site
Ibaraki, Japan Recruiting
Show 3 more locations
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GSK Investigational Site
Seoul, South Korea Recruiting -
GSK Investigational Site
Seoul, South Korea Recruiting -
GSK Investigational Site
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.