Last updated: 04/21/2026 07:00:27
First-Time-in-Human study of GSK5471713 in adults with mCRPC
GSK study ID
300164
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Trial status
Recruiting
Recruiting
Trial overview
Official title: 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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Sequential Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants with dose limiting toxicities (DLTs)
Timeframe: 28 days
Number of participants with adverse events (AEs), and serious adverse events (SAEs)
Timeframe: Approximately 45 months
Number of participants with adverse events (AEs), and serious adverse events (SAEs) by Severity
Timeframe: Approximately 45 months
Number of participants with AEs leading to dose modifications
Timeframe: Approximately 45 months
Secondary outcomes:
Maximum plasma concentration (Cmax) of GSK5471713
Timeframe: Approximately 45 months
Area under the plasma concentration-time curve from 0 to t (AUC[0-t]) of GSK5471713
Timeframe: Approximately 45 months
Time to maximum plasma concentration (Tmax) of GSK5471713
Timeframe: Approximately 45 months
Prostate-specific Antigen Decrease from Baseline >=50% (PSA50) Response Rate
Timeframe: Approximately 45 months
Objective response rate (ORR) per Prostate Cancer Working Group 3 (PCWG3) by investigator assessment
Timeframe: Approximately 45 months
Interventions:
Drug: GSK5471713
Enrollment:
54
Observational study model:
Not applicable
Primary completion date:
2028-24-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms, Prostate
Product
Not applicable
Collaborators
Not applicable
Study date(s)
February 2026 to March 2030
Type
Interventional
Phase
1/2
Participation criteria
Sex
Male
Age
18+ years
Accepts healthy volunteers
No
- 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).
- 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.
Inclusion and 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.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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