BridgeMD
New treatment option for Neoplasms, Prostate
Official title A Study of GSK5458514 Administered Alone or In Combination With Other Anti-Cancer Agents in Participants With Prostate Cancer
ClinicalTrials.gov ID: NCT06990880
What this study is testing
What is GSK5458514?
GSK5458514 is an investigational medicine, being studied as a potential treatment for neoplasms, prostate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Provide signed informed consent. Participants must be capable of providing informed consent, which includes compliance with the requirements and...
- Male participants ≥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...
- 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...
You likely can't join if
- 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...
- Curatively treated basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, and/or in situ breast cancer...
- Has ongoing adverse reaction(s) from prior therapy that have not recovered to ≤Grade 1 or to the baseline status preceding prior therapy, excluding...
See the full eligibility criteria
Who can join
- Provide signed informed consent. Participants must be capable of providing informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Male participants ≥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...
- 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...
- Documented disease progression on most recent systemic 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 GnRH agonist or antagonist; this therapy must have been initiated...
- 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...
- Participants must have adequate organ function
What rules you out
- 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...
- 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...
- 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...
- Has evidence of interstitial lung disease, non-infectious pneumonitis, and/or a history of interstitial lung disease, non-infectious pneumonitis that required steroid .
- Any anti-cancer therapy or prior systemic biologic therapy, including immunotherapy within 4 weeks of start dose.
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Rochester, Minnesota, United States
- East Brunswick, New Jersey, United States
- Nashville, Tennessee, United States
- Montreal, Quebec, Canada
- Lyon, France
- Villejuif, France
- Kanagawa, Japan
- Tokyo, Japan
- Badajoz, Spain
- Barcelona, Spain
- Madrid, Spain
- Málaga, Spain
- Pozuelo de AlarcOn Madr, Spain
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Denver, Colorado, United States; New Haven, Connecticut, United States; Rochester, Minnesota, United States; East Brunswick, New Jersey, United States; Nashville, Tennessee, United States and 10 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.