Clinical trial · Interventional
First-Time-in-Human Study of GSK5471713 in Adults With mCRPC
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)
NCT07332455CI-TRIAL-00119198recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms, Prostate | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GSK5471713 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants receiving GSK5471713
- description
- Participants will receive GSK5471713, according to their allocated dose level guided by the dose escalation study design.
- interventionNames
- Drug: GSK5471713
Primary outcomes (4)
- measure
- Number of participants with dose limiting toxicities (DLTs)
- timeFrame
- 28 days
- measure
- Number of participants with adverse events (AEs), and serious adverse events (SAEs)
- timeFrame
- Approximately 45 months
- measure
- Number of participants with adverse events (AEs), and serious adverse events (SAEs) by Severity
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.