Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 1/Phase 2
GlaxoSmithKline (Voir sur ClinicalTrials)
février 2026
mars 2030
10 novembre 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Yohann LORIOT | 03/11/2026 20:40:32 | Contacter | ||
Critères
Homme
- 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 and life
expectancy of ≥3 months (≥12 weeks).
- 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. Participants
should have received all approved standard-of-care therapies for which they are
eligible, including biomarker directed therapy, in accordance with current clinical
guidelines, unless a documented contraindication or another justified medical reason
precluded their use.
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.