First-Time-in-Human Study of GSK5471713 in Adults With mCRPC
ConditionNeoplasms, Prostate
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorGlaxoSmithKline
About this trial
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
Qualifiers
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.
Disqualifiers
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 design
Treatments tested in this trial
- GSK5471713
Treatment groups
54 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov