Neoplasms, ProstatePhase 1/2NCT06990880
A Study of GSK5458514 Administered Alone or In Combination With Other Anti-Cancer Agents in Participants With Prostate Cancer
A Phase 1/2 study testing GSK5458514 in people with Neoplasms, Prostate, run by GlaxoSmithKline at 20 sites in 5 countries.
Trial summary
The goal of the study is to evaluate how safe and how well the body handles GSK5458514 when administered in participants with prostate cancer. The study will be conducted in two parts - Part 1 (dose escalation phase) and Part 2 (dose expansion phase). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Neoplasms, Prostate
- What is being tested?
- GSK5458514
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 20 sitesin 5 countries
- Study dates
- 12 Jun 2025to 9 Aug 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide signed informed consent. Participants must be capable of providing informed consent, which includes compliance with the requirements and restrictions listed in the Informed consent form (ICF) and in this protocol.
- Male participants greater than equal to (>=)18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the ICF.
- Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 195 days, after the last dose of study intervention:
- Refrain from donating sperm
- PLUS either:
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.
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- OR
- Must agree to use contraception as detailed below:
- Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant.
- Participants with mCRPC:
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Metastatic disease diagnosed either by radiologic imaging (Positron emission tomography [PET]- Computed tomography [CT]) and/or regular CT and/or Magnetic resonance imaging (MRI) and/or bone scan
- Castration-resistant status as per PCWG3 criteria
- Has prior novel anti-androgen receptor therapy failure and had treatment failure with 1-2 taxane-based chemotherapy regimens including for metastatic hormone sensitive prostate cancer.
- Has (1) at least 1 soft tissue target lesion per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) OR (2) if Non-Target soft tissue disease only per PCWG3-modified RECIST 1.1, may be included if a rise in Prostate-specific antigen (PSA) on 2 successive determinations at least 1 week apart (the most recent screening measurement must have been >= 2 nanograms per milliliter (ng/mL) with testosterone levels <50 nanograms per deciliter (ng/dL), OR (3) bone disease defined by PCWG3 (2 or more lesions on bone scan at screening), as determined by the investigator.
- Documented disease progression on most recent systemic anti-cancer therapy defined by fulfilling at least 1 of the PCWG3 criteria
- Have serum testosterone <50 ng/dL (<1.7 nM). Patients must have undergone bilateral orchiectomy or be on continuous androgen-deprivation therapy with a Gonadotropin-releasing hormone (GnRH) agonist or antagonist; this therapy must have been initiated at least 4 weeks prior to randomization and treatment must be continued throughout the study.
- Eastern Cooperative Oncology Group (ECOG) performance status <=1, with no deterioration in the 2 weeks before step-up treatment period Day 1.
- Have supplied tumor tissue from a newly obtained biopsy or archival tumor tissue for retrospective detection of Prostate-specific membrane antigen (PSMA) expression and other biomarker analysis. Tissue from a newly obtained biopsy is preferred. If a newly obtained biopsy is not feasible, archival tumor tissue preferably taken after the completion of the participant's last line of therapy prior to the first dose of study drug is acceptable.
- Participants must have adequate organ function
Who cannot join
- Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate or any histology different from adenocarcinoma.
- History of central nervous system (CNS) metastases or leptomeningeal disease.
- Diagnosis of invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years, except as noted below:
- History of an invasive malignancy for which the participant was definitively treated, and in which the participant has been disease free for at least 2 years, and which, in the opinion of the principal investigator and medical monitor, is not expected to affect the evaluation of the effects of the study intervention on the currently targeted disease under study
- Curatively treated basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, and/or in situ breast cancer may be enrolled
- Has ongoing adverse reaction(s) from prior therapy that have not recovered to <=Grade 1 or to the baseline status preceding prior therapy, excluding [e.g., alopecia, hearing loss, vitiligo, endocrinopathy managed with replacement therapy, and Grade 2 neuropathy], or that the investigator, with the agreement of the sponsor, considers to be not clinically relevant for the tolerability of study intervention in the current clinical study.
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- Confirmed history or recurrent autoimmune disease that has required systemic treatments in the 2 years prior to screening. Participants with prior history of autoimmune disease must be discussed with the medical monitor. Replacement therapy is not considered a form of systemic therapy (e.g., thyroid hormone for autoimmune thyroiditis or insulin is not exclusionary).
- Has evidence of interstitial lung disease, non-infectious pneumonitis, and/or a history of interstitial lung disease, non-infectious pneumonitis that required steroid.
- Has received any anti-cancer therapy or prior systemic biologic therapy, including immunotherapy within 30 days prior to first dose of study intervention.
- Prior PSMA radionuclide therapy within 2 months prior to GSK5458514 unless participant received <2 cycles.
- Prior PSMA-Chimeric antigen receptor T cell therapy (CAR-T) cell therapy and PSMA (T cell engager) TCE/ Bispecific T cell engagers (BiTE) or other prostate Tumor-associated antigens (TAA) specific T cell engager (TCE).
- Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
- Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
- History of severe neurological or psychiatric disorder, including epilepsy, dementia, or major depression deemed to interfere with study assessments.
- Has had any major surgery (such as craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks prior to first dose of study intervention.
- Serious infections within 4 weeks prior to the first dose, including but not limited to infectious complications, bacteremia, severe pneumonia treated with IV antibiotics for >=2 weeks; active infections with therapeutic IV antibiotics within 2 weeks prior to the first dose or oral antibiotics within 1 week prior to the first dose. Participants who are receiving or have received prophylactic antibiotics (e.g., prophylaxis against urinary infections) are allowed.
- Liver safety exclusion criteria:
- Has an Alanine aminotransferase (ALT) value >2.5x upper limit of normal (ULN) or >5x ULN if documented history of liver metastases.
- Has a total bilirubin value >1.5x ULN.
- Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice.
- Has documented presence of Hepatitis B surface antigen (HBsAg), at screening or within 3 months prior to the first dose of study intervention.
- Has a positive Hepatitis C virus (HCV) antibody test result at screening or within 3 months prior to Cycle 1 Day 1 unless the participant can meet the following criteria: NOTE: Participants with a positive HCV antibody test result due to prior resolved disease can be enrolled if a confirmatory negative HCV RNA test is obtained and the participant otherwise meets entry criteria
- Has a positive HCV ribonucleic acid (RNA) test result at screening or within 3 months prior to the first dose of study intervention. NOTE: The HCV RNA test is optional, and participants with a negative HCV antibody test are not required to undergo HCV RNA testing as well.
- Is unable to adhere to the protocol defined SoA, including requirements for the Follow-up Period of the study, study procedures, restrictions, and requirements as determined by the investigator.
Trial locations and contacts
20 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 5 countries
United States6 sites, 6 recruiting
- Recruiting
GSK Investigational Site
Denver, Colorado, 80218-1234
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
East Brunswick, New Jersey, 08816
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Nashville, Tennessee, 37203
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
New Haven, Connecticut, 06510
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Phoenix, Arizona, 85054
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Rochester, Minnesota, 55905
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Spain6 sites, 6 recruiting
- Recruiting
GSK Investigational Site
Badajoz, 06080
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Barcelona, 08023
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Madrid, 28040
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Madrid, 28050
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Málaga, 29010
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Pozuelo de AlarcOn Madr, 28223
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Canada3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Montreal, Quebec, H3T 1E2
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Montreal, Quebec, H4A 3J1
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Toronto, Ontario, M4N 3M5
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Japan3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Kanagawa, 232-0024
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Tokyo, 104-0045
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Tokyo, 135-8550
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
France2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Lyon, 69373
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Villejuif, 94805
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Expansion Study of GSK5458514 PSMA Targeting T Cell Engager Alone or in Combination With Other Anti-cancer Agents in Adult Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)
The goal of the study is to evaluate how safe and how well the body handles GSK5458514 when administered in participants with prostate cancer. The study will be conducted in two parts - Part 1 (dose escalation phase) and Part 2 (dose expansion phase).
- Conditions
- Neoplasms, Prostate
- Being tested
- GSK5458514
- Keywords
- Metastatic castration-resistant prostate cancer (mCRPC), GSK5458514, Dose escalation, Dose expansion
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK5458514Drug
GSK5458514 will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose escalation of GSK5458514 monotherapy | Experimental | Not described Receives: Drug: GSK5458514 |
| Part 2: Dose expansion of GSK5458514 monotherapy | Experimental | Not described Receives: Drug: GSK5458514 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose limiting toxicities (DLTs) during DLT observation period
Measured: Up to 28 days
Number of participants with adverse events (AEs), serious adverse events (SAEs), by Severity
Measured: Up to approximately 29 months
Number of participants with AEs leading to dose modifications
Measured: Up to approximately 29 months
Secondary outcomes (7)
Area under concentration from 0 to t (AUC 0-t) of GSK5458514
Measured: Up to approximately 32 months
Maximum concentration (Cmax) of GSK5458514
Measured: Up to approximately 32 months
Time to reach maximum concentration (Tmax) of GSK5458514
Measured: Up to approximately 32 months
Number of participants with Anti-drug antibodies (ADA) against GSK5458514
Measured: Up to approximately 32 months
Titers of ADA against GSK5458514
Measured: Up to approximately 32 months
Prostate-specific Antigen Decrease From Baseline >=50% (PSA50) Response Rate
PSA50 response rate is defined as percentage of participants with a decrease of >=50% in the PSA concentration from the baseline PSA value, confirmed at least 3 weeks later.
Measured: Up to approximately 32 months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants in the ORR Evaluable set who have a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) per prostate cancer working group 3 (PCWG3) guidelines as assessed by investigator.
Measured: Up to approximately 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start12 Jun 2025
- Primary completion26 Oct 2027 (estimated)
- Study completion9 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, ProstateStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990880
- Sponsor's protocol ID
- 223050
- Other IDs
- 2025-521581-10-00, 2025
- Status last verified
- Sep 2026
- First submitted
- 22 May 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/gsk-patient-level-data-sharing-july2025.pdf
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Expansion Study of GSK5458514 PSMA Targeting T Cell Engager Alone or in Combination With Other Anti-cancer Agents in Adult Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)
- ClinicalTrials.gov ID
- NCT06990880
- Acronym / sponsor ID
- 223050
- Conditions
- Neoplasms, Prostate
- Keywords
- Metastatic castration-resistant prostate cancer (mCRPC), GSK5458514, Dose escalation, Dose expansion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 26 Oct 2027 (estimated)
- Study completion
- 9 Aug 2028 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study is to evaluate how safe and how well the body handles GSK5458514 when administered in participants with prostate cancer. The study will be conducted in two parts - Part 1 (dose escalation phase) and Part 2 (dose expansion phase).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose escalation of GSK5458514 monotherapy | Experimental | Drug: GSK5458514 |
| Part 2: Dose expansion of GSK5458514 monotherapy | Experimental | Drug: GSK5458514 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Provide signed informed consent. Participants must be capable of providing informed consent, which includes compliance with the requirements and restrictions listed in the Informed consent form (ICF) and in this protocol.
- Male participants greater than equal to (>=)18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the ICF.
- Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 195 days, after the last dose of study intervention:
- Refrain from donating sperm
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.
Key exclusion criteria (24 listed)
- Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate or any histology different from adenocarcinoma.
- History of central nervous system (CNS) metastases or leptomeningeal disease.
- Diagnosis of invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years, except as noted below:
- Has ongoing adverse reaction(s) from prior therapy that have not recovered to <=Grade 1 or to the baseline status preceding prior therapy, excluding [e.g., alopecia, hearing loss, vitiligo, endocrinopathy managed with replacement therapy, and Grade 2 neuropathy], or that the investigator, with the agreement of the sponsor, considers to be not clinically relevant for the tolerability of study intervention in the current clinical study.
- Confirmed history or recurrent autoimmune disease that has required systemic treatments in the 2 years prior to screening. Participants with prior history of autoimmune disease must be discussed with the medical monitor. Replacement therapy is not considered a form of systemic therapy (e.g., thyroid hormone for autoimmune thyroiditis or insulin is not exclusionary).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK5458514GSK5458514 will be administered. | Drug | Part 1: Dose escalation of GSK5458514 monotherapy, Part 2: Dose expansion of GSK5458514 monotherapy |
Primary outcome
Number of participants with dose limiting toxicities (DLTs) during DLT observation period
Time frame: Up to 28 days
Number of participants with adverse events (AEs), serious adverse events (SAEs), by Severity
Time frame: Up to approximately 29 months
Number of participants with AEs leading to dose modifications
Time frame: Up to approximately 29 months
7 secondary outcomes
Area under concentration from 0 to t (AUC 0-t) of GSK5458514
Time frame: Up to approximately 32 months
Maximum concentration (Cmax) of GSK5458514
Time frame: Up to approximately 32 months
Time to reach maximum concentration (Tmax) of GSK5458514
Time frame: Up to approximately 32 months
Number of participants with Anti-drug antibodies (ADA) against GSK5458514
Time frame: Up to approximately 32 months
Titers of ADA against GSK5458514
Time frame: Up to approximately 32 months
Prostate-specific Antigen Decrease From Baseline >=50% (PSA50) Response Rate
Time frame: Up to approximately 32 months
Objective Response Rate (ORR)
Time frame: Up to approximately 32 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Yes. 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/gsk-patient-level-data-sharing-july2025.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
GSK Clinical Trials study director
GlaxoSmithKline
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GSK5458514 in people with Neoplasms, Prostate, run by GlaxoSmithKline at 20 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Spain, Canada, Japan, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose limiting toxicities (DLTs) during DLT observation period (time frame: Up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.