Testing GSK5458514 for prostate neoplasms

Exclusion

• −Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → or medical monitor, contraindicates participation in the study.
• −History of central nervous system (CNS) metastases or leptomeningeal disease.
• −Has documented presence of Hepatitis B surface antigen (HBsAg), at screeningScreeningThe checks done before joining, to see whether a study fits.Read more → 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 enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → 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.
• −Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate or any histology different from adenocarcinoma.
• −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 reactionAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more →(s) from prior therapy that have not recovered to ≤Grade 1 or to the baselineBaselineYour starting measurements, taken before treatment begins.Read more → 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 sponsorSponsorThe organisation responsible for the study overall.Read more →, 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).
• −Has evidence of interstitial lung disease, non-infectious pneumonitis, and/or a history of interstitial lung disease, non-infectious pneumonitis that required steroid .
• −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.
• −History of severe neurological or psychiatric disorder, including epilepsy, dementia, or major depression deemed to interfere with study assessments.
• −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 criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →:
• −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.
• −Is unable to adhere to the protocolProtocolThe detailed plan a study must follow.Read more → defined SoA, including requirements for the Follow-up PeriodFollow-upContinued check-ins after the treatment part is finished.Read more → of the study, study procedures, restrictions, and requirements as determined by the investigator.
• −Any anti-cancer therapy or prior systemic biologic therapy, including immunotherapy within 4 weeks of start dose.
• −Has had any major surgery (such as craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks prior to first dose of study intervention.