GSK5458514 for Prostate Cancer

Recruiting at 1 trial location

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

82 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 will be conducted in two parts - Part 1 (dose escalation phase) and Part 2 (dose expansion phase).

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

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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