450 Participants NeededMy employer runs this trial

Mocertatug Rezetecan for Ovarian Cancer

Recruiting at 3 trial locations
Age: 18+
Sex: Female
Trial Phase: Phase 3
Sponsor: GlaxoSmithKline
Must be taking: Mirvetuximab, Bevacizumab, PARPi
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called mocertatug rezetecan (Mo-Rez) for ovarian cancer to determine if it outperforms current chemotherapy options. Researchers aim to assess the safety of Mo-Rez and how well patients tolerate it. The trial compares Mo-Rez to standard treatments like paclitaxel or a combination of drugs selected by doctors. This trial may suit someone with ovarian cancer who hasn't responded well to platinum-based chemotherapy and has tried at least one but no more than four other treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to access a potentially groundbreaking treatment.

Is there any evidence suggesting that mocertatug rezetecan is likely to be safe for humans?

Research has shown that mocertatug rezetecan, or Mo-Rez, has been studied for its safety in treating ovarian cancer. In earlier studies, about 53% of patients with ovarian cancer experienced serious side effects, known as Grade 3 or higher adverse events. These side effects were expected and are similar to those seen with other cancer treatments.

The studies also found that Mo-Rez has a manageable safety profile. While side effects occur, they are predictable and similar to those from other treatments for similar conditions. Importantly, the treatment has been tested and has worked well for many patients, with a response rate of up to 67%. Despite the side effects, the treatment has shown promising results in fighting cancer.

Overall, Mo-Rez has demonstrated tolerability in patients, but like many cancer treatments, it carries some risks. Anyone considering joining a trial should discuss these potential side effects with a healthcare provider to understand what participation might involve.12345

Why do researchers think this study treatment might be promising for ovarian cancer?

Mocertatug Rezetecan is unique because it offers a new approach to treating ovarian cancer by potentially targeting cancer cells differently than existing options like Paclitaxel or Pembrolizumab. While most standard treatments work by broadly attacking rapidly dividing cells, Mocertatug Rezetecan may have a novel mechanism of action that allows for more precise targeting of cancer cells. Researchers are excited about this treatment because it could lead to fewer side effects and improved efficacy compared to the current standard of care, making it a promising new option for patients.

What evidence suggests that mocertatug rezetecan might be an effective treatment for ovarian cancer?

Research has shown that mocertatug rezetecan, which participants in this trial may receive, holds promise for treating ovarian cancer. Studies found that this treatment reduced tumor size in 62% of patients with ovarian cancer unresponsive to platinum-based treatments. Some reports even indicate a higher success rate of 67% in similar cases. The treatment targets a protein called B7-H4, which aids cancer cell growth. These findings suggest that mocertatug rezetecan could be an effective option for ovarian cancer patients.12356

Are You a Good Fit for This Trial?

This trial is for adults with certain types of ovarian, fallopian tube, or primary peritoneal cancer that has become resistant to platinum-based chemotherapy. Participants must have tried specific prior treatments and their cancer must have returned or worsened within 6 months after their last platinum therapy.

Inclusion Criteria

I am at least 18 years old and legally able to give consent.
I have previously been treated with mirvetuximab soravtansine, unless it was not available to me.
Tumor demonstrates positive folate receptor alpha (FRα) expression ≥75% of viable tumor cells with moderate or strong membrane staining per compliant test
See 16 more

Exclusion Criteria

I have received a blood transfusion or growth factors in the past 14 days.
Known sensitivity or allergy to study intervention components contraindicating participation
Serious or unstable medical or psychiatric conditions interfering with safety, consent, or compliance
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Mocertatug rezetecan or standard of care chemotherapy

Up to approximately 212 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Mocertatug Rezetecan

Trial Overview

The study compares a new drug called mocertatug rezetecan (Mo-Rez) against standard treatments like paclitaxel, topotecan, gemcitabine, PLD, bevacizumab, or pembrolizumab in people with platinum-resistant ovarian cancer. Patients are randomly assigned to receive either Mo-Rez or one of the standard therapies.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Mocertatug rezetecanExperimental Treatment1 Intervention
Group II: Standard of careActive Control6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Collaborator

Trials
41
Recruited
19,200+

GOG Foundation

Collaborator

Trials
48
Recruited
18,500+

Asia-Pacific Gynecologic Oncology Trials Group

Collaborator

GOG, ENGOT, APGOT

Collaborator

Citations

Mocertatug Rezetecan Displays Early Efficacy, Tolerability ...

Data from BEHOLD-1 showed that the agent produced an ORR of 62% in patients with platinum-resistant ovarian cancer and 67% in those with ...

Mocertatug rezetecan, a B7-H4-targeted antibody-drug ...

The promising objective response rate (ORR) of Mo-Rez monotherapy (48.5%) in platinum-resistant ovarian cancer was reported at ESMO 2025. This study ( ...

ADC Demonstrates Early Promise in Multiple Cancer Types

Mocertatug rezetecan delivered rapid and deep responses in patients with platinum-resistant ovarian cancer or recurrent/advanced endometrial ...

Mocertatug Rezetecan Demonstrates Encouraging Activity ...

In the ovarian cancer cohort, confirmed ORR increased across dose levels, from 31% with 2.8 mg/kg to 53% with 4.8 mg/kg and 62% with 5.8 mg/kg.

GSK presents positive data for B7-H4-targeted ADC in ...

Mocertatug rezetecan achieved confirmed objective response rates of 62% in platinum-resistant ovarian cancer (PROC) and 67% in recurrent or ...

NCT07286266 | A Study to Investigate Mocertatug ...

This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) works in treating ovarian cancer compared to standard treatments.