Testing GSK5471713 in adults with metastatic castration-resistant prostate cancer
A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Dose Optimization Study of GSK5471713 in Adult Participants With Metastatic Castration Resistant Prostate Cancer (mCRPC)
This trial will test whether the experimental drug GSK5471713 is safe, tolerable, and shows early signs of benefit in adults with metastatic castration-resistant prostate cancer who have progressed on androgen-deprivation therapy and prior AR pathway inhibitors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | GlaxoSmithKline Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Grand Rapids, Michigan and 5 other locations) |
| Trial ID | NCT07332455 on ClinicalTrials.gov |
What this trial studies
This first‑in‑human, phase 1/2, open‑label trial gives GSK5471713 as a single agent to adults with metastatic castration‑resistant prostate cancer to define safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity. The study will use dose‑escalation to determine a recommended phase 2 dose and then enroll expansion cohorts to look for early signs of anti‑tumor effect. Eligible participants have histologically confirmed prostate adenocarcinoma, ECOG 0–1, progression on ADT and prior AR pathway inhibitors, and prior taxane chemotherapy as specified. Key exclusions include non‑adenocarcinoma histologies (for example small cell/neuroendocrine), significant cardiac disease, uncontrolled infection or lab abnormalities, and prior AR degrader therapy.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed prostate adenocarcinoma with metastatic castration‑resistant disease, ECOG performance status 0–1, who progressed on androgen‑deprivation therapy and at least one androgen receptor pathway inhibitor and have received one to two prior taxane‑based chemotherapy regimens.
Not a fit: Patients with non‑adenocarcinoma prostate cancers (such as small cell or neuroendocrine histology), significant cardiac impairment, uncontrolled infections or major lab abnormalities, or prior AR degrader therapy are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, GSK5471713 could offer a new treatment option that helps control disease in some patients with mCRPC who have progressed on existing AR‑directed therapies and taxanes.
How similar studies have performed: This is a first‑in‑human trial of a novel compound; while other androgen‑receptor‑targeted approaches have produced benefit in mCRPC, this specific agent has not been tested in humans before.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants with mCRPC that have histologically or cytologically confirmed adenocarcinoma of the prostate. * Participants with mCRPC that has prostate cancer progression while on Androgen deprivation therapy (ADT). * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. * Progression on ADT and \>=1 prior Androgen receptor pathway inhibitors (ARPI) for Hormone-Sensitive Prostate Cancer (HSPC) or Castration resistant prostate cancer (CRPC) and received 1-2 prior taxane based chemotherapy regimens. Exclusion Criteria: * Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, or any histology different from adenocarcinoma. * Impaired cardiac function or clinically significant cardiac disease. * Any significant medical condition, such as uncontrolled infection or clinically significant laboratory abnormality. * Prior therapy with Androgen receptor (AR) Degrader targeted therapy. Other protocol-defined inclusion/exclusion criteria apply.
Where this trial is running
Grand Rapids, Michigan and 5 other locations
- GSK Investigational Site — Grand Rapids, Michigan, United States (Recruiting)
- GSK Investigational Site — Philadelphia, Pennsylvania, United States (Recruiting)
- GSK Investigational Site — West Valley City, Utah, United States (Recruiting)
- GSK Investigational Site — Toronto, Ontario, Canada (Recruiting)
- GSK Investigational Site — Montreal, Quebec, Canada (Recruiting)
- GSK Investigational Site — Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.