Clinical Trials | Phase 1 First-in-Human (FIH), Dose Escalation and Dose Expansion Study of RYZ401, a Novel Radiopharmaceutical Therapy Labeled with Actinium-225 (225Ac), in Subjects with Neuroendocrine Tumors (NETs) and Other Selected Solid Tumors Expressing Somatostatin Receptors (SSTRs).

The UVA Comprehensive Cancer Center seeks adults ages 18 and over with Neuroendocrine Tumors (NETs) and Other Selected Solid Tumors Expressing Somatostatin Receptors (SSTRs). If you choose to participate in this study, you will receive an investigational new drug, RYZ401. This drug is investigational because it has not yet been approved by the US Food and Drug Administration (FDA) or any other regulatory agency. The purpose of this study is to find out if RYZ401 is safe and tolerable, to learn the pharmacokinetics (PK, or how the human body takes up, breaks down, and clears the study drug), and to determine the recommended Phase 2 dose of RYZ401. 3. This study is a single-arm, open-label study. This means that all participants receive the same study drug and both you and your study doctor know the study drug you are getting. The study involves receiving the investigational drugs, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn, imaging, and talking to the study doctor. If you choose to participate the study will consist of three parts: a screening period, a treatment period, and follow-up period. The screening period is where the study team will determine if you are eligible for the study. After screening, if you are deemed eligible for participation and consent to participate in the study, you will enter the treatment period. During the treatment period, you will visit the study site 7 times in Cycle 1 and 3 times per cycle from Cycle 2 through Cycle 4. A cycle lasts 42 calendar days (or 6 weeks). For the follow-up period, about 28 days after your last dose of study drug, you will visit the study site for follow-up testing every month (every 4 weeks) for 3 months and then every 3 months (every 12 weeks) after that for approximately 1 year after you completed study treatment. After this, the study team will remain in contact with you, either in person or by phone calls to see how you are doing. The investigational drug, RYZ401, will be provided by the sponsor at no cost to you. All additional study procedures that are beyond your standard medical care, including laboratory tests, physical examinations, and visits to the study center, are provided to you at no charge. Additional information can be found here: https://clinicaltrials.gov/study/NCT07165132