GSK5458514 for Prostate Cancer

Recruiting at 3 trial locations

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: GlaxoSmithKline

Must be taking: GnRH agonists/antagonists

Must not be taking: Immunotherapy, PSMA therapy

Disqualifiers: CNS metastases, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

85 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, GSK5458514, to determine its safety and tolerability in people with prostate cancer. It consists of two parts: the first part identifies the appropriate dose, and the second part evaluates this dose in a larger group. The trial seeks men with prostate cancer that has spread and no longer responds to standard hormone treatments. Participants should have previously tried other treatments, such as anti-androgen therapies and certain chemotherapies, without success. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

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

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that any anti-cancer therapy or prior systemic biologic therapy should not have been taken within 4 weeks of starting the trial. It's best to discuss your current medications with the trial team to get specific guidance.

Is there any evidence suggesting that GSK5458514 is likely to be safe for humans?

Research shows that GSK5458514 targets prostate cancer cells. This treatment is currently undergoing tests to assess its safety and how the body processes it. Since GSK5458514 is in early testing stages, information on its safety remains limited. Researchers typically focus on determining the right dose and identifying any side effects during these stages.

Patients who participate in these studies help assess the treatment's tolerability. Early trials often include only a few participants, so safety findings are preliminary. As ongoing trials continue, more information about GSK5458514's side effects and safety will emerge. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for prostate cancer, like hormone therapy and chemotherapy, work by targeting androgens or killing rapidly dividing cells. But GSK5458514 works differently, focusing on a novel mechanism that directly targets specific cancer pathways not addressed by current therapies. This unique approach could potentially lead to more effective treatment with fewer side effects, which has researchers excited about its promise.

What evidence suggests that GSK5458514 might be an effective treatment for prostate cancer?

Research has shown that GSK5458514 could be a promising treatment for prostate cancer. This treatment is a bispecific antibody, which targets cancer cells and aids the immune system in attacking them. Although limited information exists on GSK5458514's effectiveness in humans, similar treatments have shown promise by enhancing the immune system's ability to fight cancer. Early results suggest that bispecific antibodies might reduce tumor size and spread. However, more studies are needed to confirm these effects specifically in prostate cancer patients. Participants in this trial will receive GSK5458514 as monotherapy, with the trial including both dose escalation and dose expansion phases to evaluate its safety and effectiveness. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

Men 18 or older with advanced prostate cancer that's resistant to hormone therapy and has spread. They must have tried at least one anti-androgen therapy and up to two chemo treatments. Participants need a confirmed diagnosis, measurable disease, and agree to contraception if sexually active.

Inclusion Criteria

I agree to use a condom and understand the benefits of my partner using contraception.

I will not donate sperm during the trial.

I am able to understand and willing to sign the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of GSK5458514 to determine the maximum tolerated dose

Duration not specified

Dose Expansion

Participants receive GSK5458514 at the determined dose to further evaluate safety and efficacy

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 32 months

What Are the Treatments Tested in This Trial?

Interventions

• GSK5458514

Trial Overview The trial is testing GSK5458514 alone or with other cancer drugs in men with prostate cancer. It has two parts: first finding the right dose (dose escalation) and then seeing how well it works at that dose (dose expansion).

How Is the Trial Designed?

Group I: Part 2: Dose expansion of GSK5458514 monotherapy Experimental Treatment 1 Intervention

Group II: Part 1: Dose escalation of GSK5458514 monotherapy Experimental Treatment 1 Intervention

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

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

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06990880

NCT06990880 | A Study of GSK5458514 Administered ... The goal of the study is to evaluate how safe and how well the body handles GSK5458514 when administered in participants with prostate cancer.

2. withpower.com withpower.com/trial/gsk5458514-for-prostate-cancer-8989f

GSK5458514 for Prostate Cancer The goal of the study is to evaluate how safe and how well the body handles GSK5458514 when administered in participants with prostate cancer.

3. gsk.com gsk.com/media/ofspbxv2/q2-2025-pipeline-assets-and-clinical-trials-report.pdf

Pipeline assets and clinical trials appendix - Q2 2025 GSK5458514: PSMAxCD3 T cell engaging bispecific antibody, Prostate Cancer. Removed from Phase III belrestotug (GSK4428859): Anti-TIGIT antibody, Non-small ...

4. healthscout.app healthscout.app/trial_match/view_trial/NCT06990880/?back=/trial_match/view_trials/condition/prostate/%3Fpage%3D20

A Study of GSK5458514 Administered Alon… - HealthScout The goal of the study is to evaluate how safe and how well the body handles GSK5458514 when administered in participants with prostate cancer. The study ...

5. facingourrisk.org facingourrisk.org/research-clinical-trials/results/printable

Force Research Search Results | Printable This study will look at the effectiveness of a new PARP inhibitor drug called AZD5305 in combination with different hormone therapies to treat metastatic ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06990880

NCT06990880 | A Study of GSK5458514 Administered ... The goal of the study is to evaluate how safe and how well the body handles GSK5458514 when administered in participants with prostate cancer.

7. adisinsight.springer.com adisinsight.springer.com/drugs/800082439

GSK 5458514 - AdisInsight - Springer GSK 5458514 is a prostate-specific membrane antigen (PSMA) targeting T Cell engager being developed by GSK for the treatment of metastatic ...