First-Time-in-Human Study of GSK5471713 in Adults With mCRPC
Sponsor: GlaxoSmithKline
Sponsor score: 60
ClinicalTrials ID:NCT07332455
This study assesses GSK5471713's safety, tolerability, and pharmacokinetics in adults with mCRPC. Eligible participants must have confirmed adenocarcinoma, progression on ADT, ECOG PS 0-1, and prior ARPI and taxane chemotherapy. GSK5471713 will be administered in varying doses to evaluate its effects and establish a benefit/risk profile.
Patient Parameters
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Program Overview
This first-time-in-human study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary clinical activity, and establish the benefit/risk of GSK5471713 given as a monotherapy in mCRPC.
Eligibility 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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| GSK Investigational Site | 49546 | Grand Rapids | Michigan |
| GSK Investigational Site | 19107 | Philadelphia | Pennsylvania |
| GSK Investigational Site | 84119 | West Valley City | Utah |
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