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First-Time-in-Human Study of GSK5471713 in Adults With mCRPC
EU CTIS ID: 2025-523874-17-00
What this study is testing
To evaluate the safety and tolerability of GSK5471713 in participants with mCRPC and to select 2 or more doses of GSK5471713 to implement in Part 2.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male participants ≥18 years of age
- Participants with metastatic castration resistant prostate cancer (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) or post bilateral orchiectomy
- 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
- Serum testosterone level <50 ng/dL (1.7 nmol/L) during the screening period. Participants must have undergone bilateral orchiectomy or be on continuous ADT for at least 4 weeks prior to first study dose and treatment must be continued throughout the study
You likely can't join if
- Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, or any histology different from adenocarcinoma
- Any history of prior transplant
- Actively taking any medication known to increase the risk of QT interval prolongation or torsade de pointes
- Known sensitivity to study intervention components or excipients or history of severe drug allergies or severe post-treatment hypersensitivity reactions
- Prior PSMA radionuclide therapy within 2 months prior to first dose
- Prior anticancer treatments within 4 weeks prior to the first dose.
See the full eligibility criteria
- Male participants ≥18 years of age
- Participants with metastatic castration resistant prostate cancer (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) or post bilateral orchiectomy
- 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
- Serum testosterone level <50 ng/dL (1.7 nmol/L) during the screening period. Participants must have undergone bilateral orchiectomy or be on continuous ADT for at least 4 weeks prior to first study dose and treatment must be continued throughout the study
- Have adequate organ function
- Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, or any histology different from adenocarcinoma
- Any history of prior transplant
- Actively taking any medication known to increase the risk of QT interval prolongation or torsade de pointes
- Known sensitivity to study intervention components or excipients or history of severe drug allergies or severe post-treatment hypersensitivity reactions
- Prior PSMA radionuclide therapy within 2 months prior to first dose
- Prior anticancer treatments within 4 weeks prior to the first dose.
- Prior therapy with androgen receptor (AR) Degrader targeted therapy
- Abnormal, or history of abnormal, adrenal function or have an illness or are taking medications known to affect adrenal gland function.
- Any current or history of a significant liver condition, or clinically significant liver-related infection of laboratory abnormality.
- Any active renal conditions
- Untreated brain or CNS metastases or brain/CNS metastases that have progressed
- Any clinically significant gastrointestinal abnormalities
- Impaired cardiac function or clinically significant cardiac disease
- Major surgery within 4 weeks prior to first dose
- Diagnosis or history of invasive malignancy within the last 5 years, other than the disease under study
- Serious infections within 4 weeks prior to the first dose
- Ongoing adverse reaction(s) from prior therapy that have not recovered to ≤Grade 1 or to the baseline
- Active or significant chronic respiratory diseases
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- Japan
- Canada
- Korea, Democratic People's Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States; Japan; Canada; Korea, Democratic People's Republic of. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.