600 Participants NeededMy employer runs this trial

Mocertatug Rezetecan for Endometrial Cancer

Recruiting at 21 trial locations
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 endometrial cancer to determine its effectiveness compared to current treatments. Researchers aim to assess the efficacy and safety of Mo-Rez against standard treatments like doxorubicin and paclitaxel. The trial seeks participants diagnosed with endometrial cancer who have previously undergone chemotherapy without lasting results. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking advancements in endometrial cancer treatment.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking certain medications before starting. Specifically, you must not have taken any cytotoxic chemotherapy or other antitumor drugs within 30 days or 5 half-lives before the trial, and you must stop inhibitors of certain proteins 7 days before the trial. Additionally, P-gp inducers should be stopped at least 14 days before the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mocertatug rezetecan (Mo-Rez) underwent safety testing in previous studies. Common side effects include nausea (experienced by 86% of patients), tiredness (77%), a decrease in white blood cells (73%), low red blood cells (52%), and hair loss (52%). More serious side effects occurred in about 48% of patients with endometrial cancer. However, only about 3% of patients experienced lung-related issues like ILD/pneumonitis, which are more serious but less common. Overall, while some side effects occur frequently, the serious ones are less common.12345

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

Mocertatug rezetecan is unique because it represents a new approach to treating endometrial cancer. Unlike standard treatments like Paclitaxel and Doxorubicin, which generally work by interfering with cell division, Mocertatug rezetecan offers a novel mechanism that specifically targets cancer cells, potentially leading to more effective and personalized treatment. Researchers are excited about this treatment because it could provide better outcomes with fewer side effects, making it a promising option for patients who may not respond well to traditional therapies.

What evidence suggests that this trial's treatments could be effective for Endometrial Cancer?

Research has shown that the drug mocertatug rezetecan (Mo-Rez), which participants in this trial may receive, holds promise for treating endometrial cancer. Studies have found that 67% of patients with recurring or advanced endometrial cancer experienced a reduction in tumor size, meaning more than half saw their tumors shrink. Mo-Rez targets a protein called B7-H4 on cancer cells, enabling the drug to attack and destroy these cells. The treatment has also proven effective in other cancer types, with manageable side effects. These findings suggest that Mo-Rez could be a strong option for those fighting endometrial cancer. Meanwhile, participants in the standard of care arm will receive either Paclitaxel or Doxorubicin, as determined by the investigator.12346

Are You a Good Fit for This Trial?

This trial is for adults with endometrial (uterine) cancer that has come back or persisted after treatment with platinum-based chemotherapy and immunotherapy. Participants must have received these treatments before, unless they couldn't due to certain health reasons. Only those with confirmed endometrial cancer types can join.

Inclusion Criteria

My previous adjuvant or neoadjuvant therapy counts as one treatment line.
I have started a new type of drug as a separate treatment line.
I have a confirmed diagnosis of recurrent or persistent endometrial cancer.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Mocertatug rezetecan or standard of care chemotherapy (Paclitaxel or Doxorubicin) as per investigator's discretion

Up to approximately 97 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 156 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Doxorubicin
  • Mocertatug rezetecan
  • Paclitaxel

Trial Overview

The study compares a new drug called mocertatug rezetecan (Mo-Rez) to standard chemotherapy drugs (paclitaxel or doxorubicin). Participants are randomly assigned to receive either Mo-Rez or one of the standard chemo options.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Mocertatug rezetecanExperimental Treatment1 Intervention
Group II: Standard of CareActive Control2 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

GOG Foundation

Collaborator

Trials
48
Recruited
18,500+

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Collaborator

Trials
41
Recruited
19,200+

Asia-Pacific Gynecologic Oncology Trials Group

Collaborator

ENGOT, GOG, 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 ...

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 ...

Mocertatug Rezetecan Demonstrates Encouraging Activity ...

Mocertatug rezetecan demonstrated high response rates, low progression rates among responders, and manageable toxicity across both tumor types.

NCT07286331 | A Study to Investigate Mocertatug ...

This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) works in treating Endometrial Cancer (EC) compared to standard of care.

GSK Reports 67% Response Rate with Mocertatug ...

GSK reports up to 67% response rate. Mo-Rez targets B7-H4, 67% ORR in recurrent/advanced endometrial cancer Responses across multiple B7-H4 ...

Positive data presented for B7-H4-targeted ADC in ...

At the highest doses evaluated, Mo-Rez monotherapy achieved confirmed objective response rates (cORR) of 62% (5.8 mg/kg n=21/34; 95% CI: 44, 78) ...