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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) (A Phase 1/2 First-Time-in-Human study of GSK5471713 in adults with mCRPC)

First-Time-in-Human Study of GSK5471713 in Adults With mCRPC

Ishibashi Hideyasu

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

jp.gskjrct@gsk.com

Ishibashi Hideyasu

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

+81-120-561-007

jp.gskjrct@gsk.com

Recruiting

Feb. 27, 2026

Interventional

non-randomized controlled trial

open(masking not used)

dose comparison control

single assignment

treatment purpose

- 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 performance status 0 or 1.

- Progression on ADT and >=1 prior Androgen receptor pathway inhibitors for Hormone-Sensitive Prostate Cancer or Castration resistant prostate cancer and received 1-2 prior taxane based chemotherapy regimens.

- 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 degrader targeted therapy.

- Other protocol-defined inclusion/exclusion criteria apply.

Male

Metastatic Castration Resistant Prostate Cancer

GSK5471713 will be administered at different dose levels based on the dose escalation study design

- Number of participants with dose limiting toxicities (DLTs) [Time Frame: 28 days]

- Number of participants with adverse events (AEs), and serious adverse events (SAEs) [Time Frame: Approximately 45 months]

- Number of participants with adverse events (AEs), and serious adverse events (SAEs) by Severity [Time Frame: Approximately 45 months]

- Number of participants with AEs leading to dose modifications [Time Frame: Approximately 45 months]

- Maximum plasma concentration (Cmax) of GSK5471713 [Time Frame: Approximately 45 months]

- Area under the plasma concentration-time curve from 0 to t (AUC[0-t]) of GSK5471713 [Time Frame: Approximately 45 months]

- Time to maximum plasma concentration (Tmax) of GSK5471713 [Time Frame: Approximately 45 months]

- Prostate-specific Antigen Decrease from Baseline >=50% (PSA50) Response Rate [Time Frame: Approximately 45 months]
- PSA50 response is defined as a greater than or equal to (>=)50 percent (%) decline in PSA from Baseline, confirmed at least 3 weeks later.

- Objective response rate (ORR) per Prostate Cancer Working Group 3 (PCWG3) by investigator assessment [Time Frame: Approximately 45 months]
- ORR is defined as the percentage of participants in the ORR Evaluable set who have the Best overall response (BOR) of confirmed Complete response (CR) or Partial response (PR) per PCWG3 guidelines as assessed by investigator.

+81-3-3520-0111

Feb. 04, 2026

Yes

[Plan Description] IPD for this study will be made available via the Clinical Study Data Request site. [URL] http://clinicalstudydatarequest.com

United States/Canada