{
"info": {
"nct_id": "NCT06345001",
"official_title": "An Open-label Phase 1 Imaging Study to Evaluate the Biodistribution, Dosimetry, Safety and Pharmacokinetics of BAY 3630942, a 89Zr-labeled Monoclonal Antibody, With a Pre-infusion of BAY 3547922, a Monoclonal Antibody-chelator Conjugate, in Patients With Hepatocellular Carcinoma or Other Select Solid Tumors.",
"inclusion_criteria": "* Participant (male or female) must be 18 years of age inclusive, at the time of signing the informed consent.\n* Histologically confirmed HCC or non-invasive diagnosis of HCC according to American Association for the Study of Liver Diseases (AASLD) criteria\n* Histologically or cytologically confirmed solid tumors\n* Child-Pugh class A and B7\n* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1\n* Able to tolerate the study procedures, including 3 PET/CT scans\n* Adequate bone marrow, hepatic, and renal function\n* Agreed to take proper contraception measures\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Impaired cardiac function or clinically significant cardiac disease (i.e., congestive heart failure New York Heart Association [NYHA] Class II, III or IV).\n* Patients with arterial thrombotic or embolic events or venous pulmonary embolism within 3 months before the start of study intervention.\n* On-going systemic anticancer therapy except continued luteinizing hormone-releasing hormone (LHRH) agonist or antagonists in participants with prostate adenocarcinoma\n* Administered a radioisotope within 9 physical half-lives of that radioisotope (24 days for yttrium-90 or 90Y) before administration of the study interventions\n* Any local or locoregional therapy of intrahepatic tumor lesions, open biopsy or significant traumatic injury < 4 weeks before administration of the study interventions.\n* Known hypersensitivity to human monoclonal antibodies.\n* Any condition which, in the opinion of the Investigator, would preclude participation in this study.",
"miscellaneous_criteria": ""
},
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