GSK5471713 for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment, GSK5471713 (an experimental drug), for individuals with prostate cancer that has spread and become resistant to standard hormone treatments. Researchers aim to determine the drug's safety, its behavior in the body, and its potential benefits for patients. Participants should have prostate cancer that continues to grow despite hormone therapy and at least one type of chemotherapy. Those meeting these criteria might be suitable for the trial. As a Phase 1/Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group of patients.
Is there any evidence suggesting that GSK5471713 is likely to be safe for humans?
Research has shown that GSK5471713 is undergoing testing to determine its safety for people. In one study with nine participants, 66.7% experienced a noticeable decrease in PSA levels, a marker for prostate cancer. This suggests potential effectiveness. So far, no specific information about serious side effects has emerged, which is encouraging. However, as this is an early study, researchers continue to monitor the treatment closely for any safety issues. Participants in early trials may face unknown risks, but the initial safety results are promising.12345
Why do researchers think this study treatment might be promising for prostate cancer?
Unlike the standard treatments for prostate cancer, which typically involve hormone therapy, chemotherapy, or surgery, GSK5471713 offers a new approach by targeting specific molecular pathways involved in cancer growth. Researchers are excited about GSK5471713 because it potentially represents a more precise way to attack cancer cells, minimizing damage to healthy tissues. This innovative mechanism could lead to better outcomes with fewer side effects, making it a promising option for patients with prostate cancer.
What evidence suggests that GSK5471713 might be an effective treatment for prostate cancer?
Research on GSK5471713, the treatment under study in this trial, remains in the early stages, but promising signs have emerged. Initial findings suggest that the treatment may lower PSA levels, which track prostate cancer progression. In some cases, PSA levels dropped by 50% or more. This potential reduction might indicate that the treatment could help slow the cancer's growth. However, further studies are needed to fully understand its effectiveness in treating metastatic castration-resistant prostate cancer (mCRPC).12346
Who Is on the Research Team?
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive GSK5471713 as a monotherapy, with dose escalation and optimization
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GSK5471713
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive GSK5471713, according to their allocated dose level guided by the dose escalation study design.
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
First-Time-in-Human Study of GSK5471713 in Adults With ...
PSA50 response is defined as a greater than or equal to (>=)50 percent (%) decline in PSA from Baseline, confirmed at least 3 weeks later. Approximately 45 ...
GSKTrial ID 300164
First-Time-in-Human study of GSK5471713 in adults with mCRPC. Contact us about the trial. GSK study ID. 300164.
3.
trial.medpath.com
trial.medpath.com/clinical-trial/633070a35b59c81d/nct07332455-gsk5471713-metastatic-castration-resistant-prostate-cancer-mcrpcFirst-Time-in-Human Study of GSK5471713 in... | Clinical Trial
This first-time-in-human study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary clinical...
A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, ...
A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Dose Optimization Study of GSK5471713 in Adult Participants ...
5.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/GSK/pressreleases/37022569/gsk-advances-new-first-in-human-prostate-cancer-drug-into-early-clinical-testing/GSK Advances New First-in-Human Prostate Cancer Drug ...
The study of GSK5471713 in metastatic castration‑resistant prostate cancer is in the start‑up phase and remains ongoing in planning, with ...
Newsletter 3/2026
In an analysis of nine participants, 66.7% achieved a PSA50 response, while 33.3% reached the PSA80 threshold. The safety profile remains ...
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