Health TrialsbyHealthPanel

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

ConditionNeoplasms, Prostate
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorGlaxoSmithKline

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • GSK5471713

    Drug

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

Treatment groups

54 Participants
are divided into 1 treatment group
Group A: Participants receiving GSK5471713Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with dose limiting toxicities (DLTs)

Time frame
28 days
2

Number of participants with adverse events (AEs), and serious adverse events (SAEs)

Time frame
Approximately 45 months
3

Number of participants with adverse events (AEs), and serious adverse events (SAEs) by Severity

Time frame
Approximately 45 months
4

Number of participants with AEs leading to dose modifications

Time frame
Approximately 45 months

Secondary outcomes

1

Maximum plasma concentration (Cmax) of GSK5471713

Time frame
Approximately 45 months
2

Area under the plasma concentration-time curve from 0 to t (AUC[0-t]) of GSK5471713

Time frame
Approximately 45 months
3

Time to maximum plasma concentration (Tmax) of GSK5471713

Time frame
Approximately 45 months
4

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.

Time frame
Approximately 45 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GlaxoSmithKline

Lead sponsor

Source ClinicalTrials.gov
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