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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523874-17 | Other Identifier | EU CT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving GSK5471713 | Experimental | Participants will receive GSK5471713, according to their allocated dose level guided by the dose escalation study design. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK5471713 | Drug | GSK5471713 will be administered at different dose levels based on the dose escalation study design |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with dose limiting toxicities (DLTs) | 28 days | |
| Number of participants with adverse events (AEs), and serious adverse events (SAEs) | Approximately 45 months | |
| Number of participants with adverse events (AEs), and serious adverse events (SAEs) by Severity | Approximately 45 months | |
| Number of participants with AEs leading to dose modifications | Approximately 45 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of GSK5471713 | Approximately 45 months | |
| Area under the plasma concentration-time curve from 0 to t (AUC[0-t]) of GSK5471713 | Approximately 45 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Recruiting | La Jolla | California | 92093 | United States |
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Time to maximum plasma concentration (Tmax) of GSK5471713 |
| Approximately 45 months |
| Prostate-specific Antigen Decrease from Baseline >=50% (PSA50) Response Rate | PSA50 response is defined as a greater than or equal to (>=)50 percent (%) decline in PSA from Baseline, confirmed at least 3 weeks later. | Approximately 45 months |
| Objective response rate (ORR) per Prostate Cancer Working Group 3 (PCWG3) by investigator assessment | 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. | Approximately 45 months |
| GSK Investigational Site | Recruiting | Grand Rapids | Michigan | 49546 | United States |
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| GSK Investigational Site | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| GSK Investigational Site | Recruiting | West Valley City | Utah | 84119 | United States |
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| GSK Investigational Site | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
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| GSK Investigational Site | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
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| GSK Investigational Site | Recruiting | Tokyo | 104-0045 | Japan |
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| GSK Investigational Site | Recruiting | Tokyo | 135-8550 | Japan |
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| GSK Investigational Site | Recruiting | Seoul | Seoul Teugbyeolsi | 06351 | South Korea |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |