Ovarian NeoplasmsPhase 3NCT07286266
A Study to Investigate Mocertatug Rezetecan Compared With Standard of Care in Participants With Platinum-resistant Ovarian Cancer (BEHOLD-Ovarian01)
A Phase 3 study testing Mocertatug rezetecan, Paclitaxel and Pegylated liposomal doxorubicin (PLD) in people with Ovarian Neoplasms, run by GlaxoSmithKline at 22 sites in 5 countries.
Trial summary
This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) works in treating ovarian cancer compared to standard treatments. The study also assesses whether Mo-Rez is safe and tolerated well by participants compared to standard treatments and aims to provide a better understanding of the main side… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- Mocertatug rezetecan, Paclitaxel and Pegylated liposomal doxorubicin (PLD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 22 sitesin 5 countries
- Study dates
- 18 Jun 2026to 22 Jul 2030
- Phase
- Phase 3
- 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
- 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 cancer, inclusive of primary peritoneal or fallopian-tube cancer with a histologically confirmed diagnosis of high grade serous, high grade endometrioid, or clear cell carcinoma, or carcinosarcoma that is resistant to platinum-based therapy.
- Platinum-resistance is defined as follows:
- Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, must have had a response (CR, PR, stable disease) and then progressed from >3 months to ≤6 months after the last dose of platinum therapy.
- Participants who have received >1 line of platinum therapy must have progressed on or ≤6 months after the date of the last dose of platinum therapy.
- Has received at least 1 but no more than 4 prior lines of systemic anti-cancer therapy. Prior lines of therapy are defined as follows:
Show all 35Show fewer
- Adjuvant ± neoadjuvant are considered one line of therapy.
- Maintenance therapy (e.g., bevacizumab, [poly adenosine diphosphate-ribosylation (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 of therapy (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.
- Must have received prior treatment with the following therapies unless they have a contraindication per label or institutional guidelines as described below:
- Mirvetuximab soravtansine (MIRV),.
- The tumor demonstrates positive folate receptor alpha FRα expression (≥ 75% of viable tumor cells with moderate (2+) and/or strong (3+) membrane staining) per a test compliant to local regulation, AND
- Does not have a documented contraindication per label or local institutional guidelines, including but not limited to chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, monocular vision, peripheral neuropathy, interstitial lung disease, or hypersensitivity. AND
- It is available in the enrolment country. A regimen is considered available if it is approved and reimbursed (covered by national healthcare or private insurance) in the participating country.
- Bevacizumab, unless the participant has a documented contraindication per label or local institutional guidelines. Contraindications include but are not limited to vascular disorders (uncontrolled hypertension, arterial thromboembolic events), fistula, gastro-intestinal disorders (rectosigmoid involvement, bowel obstruction), delayed wound healing, bleeding diathesis (haemoptysis, epistaxis, pulmonary haemorrhage, acquired coagulopathy), nephrotic syndrome or significant proteinuria, or osteonecrosis of the jaw, or hypersensitivity
- PARPi, in participants with known or suspected deleterious germline or somatic BRCA mutations and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase PARPi as maintenance treatment, if a PARPi is available in the enrolment country, unless the participants is not eligible for treatment with PARPi. A regimen is considered available if it is approved and reimbursed (covered by national healthcare or private insurance) in the participating country.
- Has at least one Target lesion (TL) per RECIST 1.1, as determined by the investigator. Measurable lesions that have been previously irradiated and have been shown to be progressing following irradiation may be considered as TLs.
- Has provided a Formalin fixed, paraffin embedded (FFPE) tumor tissue sample of sufficient quantity and quality for the central assessment of B7 homolog 4 protein (B7-H4) expression, with B7-H4 expression result available prior to date of randomization.
- AND
- FR alpha expression
- In countries where mirvetuximab is available, an FR alpha expression result from a test compliant with local regulation or by central testing is required to determine eligibility.
- In countries where mirvetuximab is unavailable, an FFPE tumor tissue sample confirmed to be of sufficient quantity and quality must be provided. The FR alpha expression result is not required prior to randomisation or to determine eligibility.
- AND
- PD-L1 expression, where a result from a local test is NOT available, an FFPE tumor tissue sample confirmed to be of sufficient quantity and quality must be provided. The PD-L1 expression result is not required prior to randomisation or to determine eligibility.
- Is eligible to receive 1 of the standard of care interventions if randomized to physician's choice arm.
- A female participant is eligible to participate if they are not pregnant or breastfeeding, and one 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), 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
- If a urine test is positive or ambiguous and cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the study protocol.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has adequate organ function
Who cannot join
- Has primary platinum-refractory Ovarian Cancer (OC), defined as disease that did not respond to or has progressed within <3 months of the final dose of first line platinum containing chemotherapy.
- Has a malignancy (except disease under study) that has progressed or required active treatment within 36 months prior to date of randomization, except for basal cell or squamous cell carcinomas of the skin, 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 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 date of C1D1 are not excluded from participation.
- Has any evidence of current 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 e.g., alopecia, hearing loss, vitiligo, endocrinopathy managed with replacement therapy, and 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.
Show all 16Show fewer
- 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, including requirements for the Follow-up Period of the study.
- For participants selected to receive the pembrolizumab-containing regimen as the intended physician's choice only: Has experienced any of the following with prior immunotherapy-any immune-mediated adverse event (imAE) ≥ Grade 3, immune-mediated severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome [SJS], Toxic Epidermal Necrolysis [TEN], or drug reaction with eosinophilia and systemic symptoms [DRESS] syndrome), or myocarditis of any grade
- For participants selected to receive bevacizumab as part of the pembrolizumab + paclitaxel ± bevacizumab intended physician's choice regimen only: Has a history of vascular disorders (uncontrolled hypertension, arterial thromboembolic events), fistula, gastro-intestinal disorders (rectosigmoid involvement, bowel obstruction), delayed wound healing, bleeding diathesis (hemoptysis, epistaxis, pulmonary hemorrhage, acquired coagulopathy), nephrotic syndrome or significant proteinuria, or osteonecrosis of the jaw, or hypersensitivity.
- Has had any major surgery within 28 days prior to date of C1D1 or received focal radiotherapy within 21 days prior to date of C1D1.
- Has received treatment with an investigational agent within 30 days prior to date of C1D1.
- Has received treatment with any cytotoxic chemotherapy drugs or other anti-tumor drugs (including endocrine therapy, molecular targeted therapy, immunotherapy, biotherapy, or investigational agent) within 30 days or 5 half-lives, whichever is shorter, prior to date of C1D1; or need to continue these drugs during study participation.
- Has ever received prior therapy with topoisomerase I inhibitors (e.g., topotecan) or ADC with a topo1i payload, or B7-H4 targeted therapy.
- Has received any live vaccine within 30 days prior to 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 (G-CSF), granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 14 days prior to date of C1D1.
- For participants receiving PLD only: Has baseline Left ventricular ejection fraction (LVEF) <50% or lower than institutional lower limits of normal. Intolerance to PLD does not exclude a participant from the study if a different physician's choice option is chosen prior to randomization.
Trial locations and contacts
22 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 5 countries
Japan11 sites, 11 recruiting
- Recruiting
GSK Investigational Site
Fukuoka, 811-1395
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Fukuoka, 830-0011
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Hokkaido, 060-8648
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Hyōgo, 673-8558
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Kanagawa, 216-8511
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Kanagawa, 241-8515
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Mie, 514-8507
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Okinawa, 901-2725
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Osaka, 569-8686
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Saitama, 350-1298
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Tottori, 683-8504
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
South Korea5 sites, 5 recruiting
- Recruiting
GSK Investigational Site
Gyeonggi-do, 10408
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Seoul, Seoul Teugbyeolsi, 06351
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Seoul, 03722
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Seoul, 05505
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Suwon Kyunggi-do, 443-380
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Canada3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Montreal, Quebec, H2X 0C1
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Montreal, Quebec, H4A 3J1
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Toronto, Ontario, M5G 1Z5
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Australia2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Auchenflower, Queensland, 4066
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Randwick, New South Wales, 2031
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
United Kingdom1 site, 1 recruiting
- Recruiting
GSK Investigational Site
London, NW1 2BU
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Randomized, Open-label, Multicenter, Phase 3 Study to Investigate Mocertatug Rezetecan Compared With Standard of Care in Participants With Platinum-resistant Ovarian Cancer
This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) works in treating ovarian cancer compared to standard treatments. The study also assesses whether Mo-Rez is safe and tolerated well by participants compared to standard treatments and aims to provide a better understanding of the main side effects of the drug.
- Conditions
- Ovarian Neoplasms
- Being tested
- Mocertatug rezetecan, Paclitaxel, Pegylated liposomal doxorubicin (PLD), Topotecan, Gemcitabine
- Keywords
- Platinum-resistant Ovarian Cancer, Mocertatug rezetecan, Mo-Rez, GSK5733584, Paclitaxel, Pembrolizumab, Bevacizumab, Pegylated liposomal doxorubicin (PLD), Topotecan, Gemcitabine, Antibody-drug conjugate, BEHOLD-Ovarian01
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mocertatug rezetecanDrug
Mocertatug rezetecan will be administered
PaclitaxelDrug
Paclitaxel will be administered
Pegylated liposomal doxorubicin (PLD)Drug
PLD will be administered
TopotecanDrug
Topotecan will be administered
GemcitabineDrug
Gemcitabine will be administered
PembrolizumabDrug
Pembrolizumab will be administered
BevacizumabDrug
Bevacizumab will be administered
| Study group | Role | What they receive |
|---|---|---|
| Mocertatug rezetecan | Experimental | Participants will receive Mocertatug rezetecan Receives: Drug: Mocertatug rezetecan |
| Standard of care | Active comparator | Participants will receive standard of care chemotherapy (Paclitaxel or Pembrolizumab + paclitaxel ± bevacizumab or PLD or Topotecan or Gemcitabine) as per investigator's choice Receives: Drug: Paclitaxel; Drug: Pegylated liposomal doxorubicin (PLD); Drug: Topotecan; Drug: Gemcitabine; Drug: Pembrolizumab; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) by BICR
PFS is defined as the time from the date of randomization to the date of first documented Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by Blinded independent central review (BICR) assessment or death from any cause, whichever occurs first.
Measured: Up to approximately 212 weeks
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause
Measured: Up to approximately 212 weeks
Secondary outcomes (18)
PFS by investigator assessment
PFS is defined as the time from the date of randomization to the date of first documented PD per RECIST 1.1 by investigator assessment or death from any cause, whichever occurs first
Measured: Up to approximately 212 weeks
Objective response rate (ORR) by BICR
ORR is defined as the percentage of participants with best overall response of either complete response (CR) or partial response (PR) per RECIST 1.1 by BICR assessment
Measured: Up to approximately 212 weeks
Duration of Response (DOR) by BICR
DOR is defined as the time from the date of first documented objective response (CR or PR) per RECIST 1.1 by BICR assessment to the date of first documented Progressive Disease (PD) per RECIST 1.1 by BICR assessment or death due to any cause, whichever occurs first
Measured: Up to approximately 212 weeks
ORR by investigator assessment
ORR is defined as the percentage of participants with best overall response of either CR or PR per RECIST 1.1 by investigator assessment
Measured: Up to approximately 212 weeks
DOR by investigator assessment
DOR is defined as the time from the date of first documented objective response (CR or PR) per RECIST 1.1 by investigator assessment to the date of first documented PD per RECIST 1.1 by investigator assessment or death due to any cause, whichever occurs first
Measured: Up to approximately 212 weeks
PFS2
PFS2 is defined as the time from the date of randomization to the date of first documented investigator-assessed clinical or radiographical progression following the first subsequent anticancer therapy and after the progression event used for PFS, or death from any cause, whichever occurs first
Measured: Up to approximately 212 weeks
Number of participants with Treatment-emergent adverse event (TEAEs), Adverse event of special interest (AESIs) and Treatment-emergent serious adverse event (TESAEs)
Measured: Up to approximately 212 weeks
Number of participants with TEAEs/AESI/TESAEs leading to dose modifications or study intervention discontinuation
Measured: Up to approximately 212 weeks
Number of participants with changes in vital signs, laboratory tests (hematology and clinical chemistry), and Electrocardiogram (ECG)
Measured: Up to approximately 212 weeks
Serum concentration of Mo-Rez (conjugated antibody and free payload)
Measured: Up to approximately 212 weeks
Number of participants with Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Mo-Rez
Measured: Up to approximately 212 weeks
Titers of ADA against Mo-Rez
Measured: Up to approximately 212 weeks
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score
The EORTC QLQ-C30 includes 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. The following domains will be measured: Global health status (GHS)/ Quality of Life (QoL), physical functioning, role functioning Participants responses on these items are . averaged and then transformed to scores . ranging from 0 to 100. Higher . score indicates better functioning or a better . overall state of health.
Measured: Up to approximately 212 weeks
Change from baseline in EORTC QLQ-Ovarian Cancer Module (OV28) score
The EORTC QLQ-OV28 includes a 28-item questionnaire for evaluating ovarian cancer-specific symptoms and concerns in participants of cancer clinical studies. These include items that assess symptoms in the abdominal/gastrointestinal domain. Scores are averaged and transformed to a 0 to 100 scale; higher scores indicate a greater symptom burden, while lower scores reflect fewer symptoms.
Measured: Up to approximately 212 weeks
Time to deterioration (TTD) of EORTC QLQ-OV28
TTD is defined as the time from the date of randomization to the first confirmed clinically meaningful deterioration on the abdominal/gastrointestinal symptom domain of the EORTC QLQ-OV28
Measured: Up to approximately 212 weeks
TTD of EORTC QLQ-C30
TTD is defined as the time from the date of randomization to the first confirmed clinically meaningful deterioration on any of the following EORTC QLQ-C30 domains: physical functioning, role functioning and Global Health Status (GHS)/ Quality of Life (QoL).
Measured: Up to approximately 212 weeks
Maximum Post-baseline Patient-reported outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) Score
The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicities in participants in cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE. A subset of items selected from the PRO-CTCAE item library will be assessed. This measure captures maximum post-baseline PRO-CTCAE score for each frequency, severity and/or interference of symptomatic AEs
Measured: Up to approximately 212 weeks
CA-125 response rate as per Gynecologic Cancer InterGroup (GCIG) criteria.
Percentage of participants with a CA-125 response will be assessed
Measured: Up to approximately 212 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start18 Jun 2026
- Primary completion22 Jul 2030 (estimated)
- Study completion22 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GOG, ENGOT, APGOT
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286266
- Sponsor's protocol ID
- 224031
- Other IDs
- 2025-523361-25-00, GOG-3132, ENGOT-ov98, APGOT-OV24, 2025
- Status last verified
- Oct 2026
- First submitted
- 12 Dec 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicenter, Phase 3 Study to Investigate Mocertatug Rezetecan Compared With Standard of Care in Participants With Platinum-resistant Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07286266
- Acronym / sponsor ID
- 224031
- Conditions
- Ovarian Neoplasms
- Keywords
- Platinum-resistant Ovarian Cancer, Mocertatug rezetecan, Mo-Rez, GSK5733584, Paclitaxel, Pembrolizumab, Bevacizumab, Pegylated liposomal doxorubicin (PLD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- GOG, ENGOT, APGOT
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- 22 Jul 2030 (estimated)
- Study completion
- 22 Jul 2030 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) works in treating ovarian cancer compared to standard treatments. The study also assesses whether Mo-Rez is safe and tolerated well by participants compared to standard treatments and aims to provide a better understanding of the main side effects of the drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mocertatug rezetecan | Experimental | Drug: Mocertatug rezetecanParticipants will receive Mocertatug rezetecan |
| Standard of care | Active comparator | Drug: Paclitaxel, Drug: Pegylated liposomal doxorubicin (PLD), Drug: Topotecan, Drug: Gemcitabine, Drug: Pembrolizumab, Drug: BevacizumabParticipants will receive standard of care chemotherapy (Paclitaxel or Pembrolizumab + paclitaxel ± bevacizumab or PLD or Topotecan or Gemcitabine) as per investigator's choice |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (35 listed)
- 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 cancer, inclusive of primary peritoneal or fallopian-tube cancer with a histologically confirmed diagnosis of high grade serous, high grade endometrioid, or clear cell carcinoma, or carcinosarcoma that is resistant to platinum-based therapy.
- Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, must have had a response (CR, PR, stable disease) and then progressed from >3 months to ≤6 months after the last dose of platinum therapy.
- Participants who have received >1 line of platinum therapy must have progressed on or ≤6 months after the date of the last dose of platinum therapy.
- Adjuvant ± neoadjuvant are considered one line of therapy.
Key exclusion criteria (16 listed)
- Has primary platinum-refractory Ovarian Cancer (OC), defined as disease that did not respond to or has progressed within <3 months of the final dose of first line platinum containing chemotherapy.
- Has a malignancy (except disease under study) that has progressed or required active treatment within 36 months prior to date of randomization, except for basal cell or squamous cell carcinomas of the skin, 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 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 date of C1D1 are not excluded from participation.
- Has any evidence of current ILD or pneumonitis, or a prior history of ILD or non-infectious pneumonitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mocertatug rezetecanMocertatug rezetecan will be administered | Drug | Mocertatug rezetecan |
| PaclitaxelPaclitaxel will be administered | Drug | Standard of care |
| Pegylated liposomal doxorubicin (PLD)PLD will be administered | Drug | Standard of care |
| TopotecanTopotecan will be administered | Drug | Standard of care |
| GemcitabineGemcitabine will be administered | Drug | Standard of care |
| PembrolizumabPembrolizumab will be administered | Drug | Standard of care |
| BevacizumabBevacizumab will be administered | Drug | Standard of care |
Primary outcome
Progression Free Survival (PFS) by BICR
Time frame: Up to approximately 212 weeks
PFS is defined as the time from the date of randomization to the date of first documented Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by Blinded independent central review (BICR) assessment or death from any cause, whichever occurs first.
Overall Survival (OS)
Time frame: Up to approximately 212 weeks
OS is defined as the time from the date of randomization to the date of death due to any cause
18 secondary outcomes
PFS by investigator assessment
Time frame: Up to approximately 212 weeks
Objective response rate (ORR) by BICR
Time frame: Up to approximately 212 weeks
Duration of Response (DOR) by BICR
Time frame: Up to approximately 212 weeks
ORR by investigator assessment
Time frame: Up to approximately 212 weeks
DOR by investigator assessment
Time frame: Up to approximately 212 weeks
PFS2
Time frame: Up to approximately 212 weeks
Number of participants with Treatment-emergent adverse event (TEAEs), Adverse event of special interest (AESIs) and Treatment-emergent serious adverse event (TESAEs)
Time frame: Up to approximately 212 weeks
Number of participants with TEAEs/AESI/TESAEs leading to dose modifications or study intervention discontinuation
Time frame: Up to approximately 212 weeks
Number of participants with changes in vital signs, laboratory tests (hematology and clinical chemistry), and Electrocardiogram (ECG)
Time frame: Up to approximately 212 weeks
Serum concentration of Mo-Rez (conjugated antibody and free payload)
Time frame: Up to approximately 212 weeks
Number of participants with Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Mo-Rez
Time frame: Up to approximately 212 weeks
Titers of ADA against Mo-Rez
Time frame: Up to approximately 212 weeks
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score
Time frame: Up to approximately 212 weeks
Change from baseline in EORTC QLQ-Ovarian Cancer Module (OV28) score
Time frame: Up to approximately 212 weeks
Time to deterioration (TTD) of EORTC QLQ-OV28
Time frame: Up to approximately 212 weeks
TTD of EORTC QLQ-C30
Time frame: Up to approximately 212 weeks
Maximum Post-baseline Patient-reported outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) Score
Time frame: Up to approximately 212 weeks
CA-125 response rate as per Gynecologic Cancer InterGroup (GCIG) criteria.
Time frame: Up to approximately 212 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Related trials for Ovarian Neoplasms
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mocertatug rezetecan, Paclitaxel and Pegylated liposomal doxorubicin (PLD) in people with Ovarian Neoplasms, run by GlaxoSmithKline at 22 sites in 5 countries.
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 35 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Japan, South Korea, Canada, Australia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.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) by BICR (time frame: Up to approximately 212 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.