Neoplasms, Prostate
Conditions
Keywords
Metastatic castration-resistant prostate cancer, First-Time-in-Human, GSK5471713, Prostate cancer
Brief summary
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.
Interventions
DRUGGSK5471713
GSK5471713 will be administered at different dose levels based on the dose escalation study design
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Time to maximum plasma concentration (Tmax) of GSK5471713 | Approximately 45 months | — |
| Prostate-specific Antigen Decrease from Baseline >=50% (PSA50) Response Rate | 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 | 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. |
Countries
Australia, Canada, France, Japan, Netherlands, South Korea, Spain, United States
Contacts
CONTACTUS GSK Clinical Trials Call Center
CONTACTEU GSK Clinical Trials Call Center
STUDY_DIRECTORGSK Clinical Trials
GlaxoSmithKline
Outcome results
None listed