GSK5764227 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new medicine, GSK5764227, which targets and kills cancer cells while sparing healthy cells. Researchers aim to determine if combining GSK5764227 with standard treatments is safe and effective for shrinking or controlling certain cancers. The trial focuses on individuals with specific types of advanced cancer: metastatic colorectal cancer or metastatic prostate cancer unresponsive to hormone therapy. Those living with one of these conditions and meeting the criteria might be suitable for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that you should not have received immunosuppressive agents within 30 days before starting the study. Low-dose corticosteroids are allowed.
Is there any evidence suggesting that GSK5764227 is likely to be safe for humans?
Research shows that GSK5764227, the treatment under study, remains in the early testing stages. Researchers are still learning about its safety for people. However, some studies have begun to provide insights. For instance, the treatment has been tested in individuals with advanced cancers, such as colorectal and prostate cancer.
Initial findings indicate that side effects like rash and mouth sores have been observed, while more serious side effects were less common. The FDA has given special recognition to the treatment for its potential use in another type of cancer, suggesting it could be promising.
As GSK5764227 is in the early phase of testing, the main focus is on understanding its tolerability and potential side effects. Although much remains to be learned, researchers are closely monitoring its safety as they continue their work.12345Why do researchers think this study treatment might be promising?
Researchers are excited about GSK5764227 because it offers a novel approach for treating metastatic colorectal cancer (mCRC) and metastatic castration-resistant prostate cancer (mCRPC). Unlike traditional treatments like chemotherapy, which broadly attack cancer cells, GSK5764227 targets specific pathways that are crucial for cancer cell survival and growth. This targeted mechanism could potentially lead to more effective treatments with fewer side effects. Additionally, GSK5764227 might work for patients who have not responded well to existing therapies, offering new hope for those with advanced cancer stages.
What evidence suggests that GSK5764227 might be an effective treatment for cancer?
Research has shown that GSK5764227 holds promise for cancer treatment by delivering a toxin directly to cancer cells while sparing healthy cells. In this trial, participants with metastatic colorectal cancer will join either cohort A1 or A2. Previous studies have demonstrated that 81.8% of patients in these cohorts experienced a halt in cancer growth, a positive outcome. Participants with metastatic castration-resistant prostate cancer will join cohort B, where GSK5764227 may help by uniquely targeting cancer cells. Early results in other cancer types showed an 86% rate of stopping cancer growth, which is encouraging. These findings suggest that GSK5764227 could effectively control cancer growth.14567
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors, specifically unresectable adenocarcinoma of the colon or rectum (Cohort A), or prostate cancer (Cohort B). Participants must be in good physical condition (ECOG status 0-1) and have stable health without deterioration in the past two weeks. They also need to have proper organ function.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive GSK5764227 in combination with standard treatments to evaluate safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GSK5764227
Trial Overview
The study tests GSK5764227, a new drug aimed at targeting and destroying cancer cells while sparing healthy ones. It's being combined with standard treatments like Fluorouracil, leucovorin, Enzalutamide, and Bevacizumab to evaluate its safety, how it's processed by the body, immune response activation, and effectiveness in shrinking or controlling cancer.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School
Citations
NCT07277270 | A Study of GSK5764227 in Combination ...
The study will combine GSK5764227 with standard treatments to evaluate its safety, examine how the body processes it, check if it triggers any immune responses, ...
2.
prostatewarriors.com
prostatewarriors.com/2025/12/12/gsk5764227-an-antibody-drug-conjugate-targeting-b7-h3-enters-phase-1-2-trial/An Antibody-Drug Conjugate Targeting B7-H3 Enters Phase 1/2 ...
This trial builds on the drug's half-life of 3-7 days and dose-proportional exposure, positioning it to potentially overcome resistance mechanisms in mCRPC ...
3.
onclive.com
onclive.com/view/fda-grants-btd-to-gsk5764227-for-extensive-stage-small-cell-lung-cancerFDA Grants BTD to GSK5764227 for Extensive-Stage ...
The disease control rate (DCR) was 81.8% (95% CI, 48.2%-97.7%). Moreover, the median progression-free survival (PFS) was 4.7 months (95% CI, 1.4 ...
Pipeline assets and clinical trials appendix - Q2 2025
other anti-cancer agents in adult participants with metastatic castration-resistant prostate cancer (mCRPC). Timeline. Trial start: Q2 2025. Key end points.
10 Most Promising Cancer Drugs Not Yet Approved in 2025
In relapsed/refractory osteosarcoma, GSK5764227 achieved an Objective Response Rate (ORR) of 20% and Disease Control Rate (DCR) of 86%, markedly ...
6.
massgeneral.org
massgeneral.org/cancer-center/clinical-trials-and-research/search-clinical-trials?cancerCondition=Prostate+CancerSearch Cancer Clinical Trials
Mass General Brigham Cancer Institute offers patients access to a wide variety of clinical trials of promising new therapies.
7.
clinicaltrials.eu
clinicaltrials.eu/trial/testing-gsk5764227-combined-with-standard-cancer-treatments-in-patients-with-advanced-solid-tumors-to-evaluate-safety-and-effectiveness/Testing GSK5764227 combined with standard cancer ...
Testing GSK5764227 combined with standard cancer treatments in patients with advanced solid tumors to evaluate safety and effectiveness.
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