A Phase 1/2 Dose Escalation Study of CRN09682 With an Expansion Phase in Participants with Progressive Metastatic Somatostatin Receptor Type 2 (SST2)-Expressing Neuroendocrine Neoplasms (NENs) and Other SST2-Expressing Solid Tumors
Headline: A Phase 1/2 Dose Escalation Study of CRN09682 With an Expansion Phase in Participants with Progressive Metastatic Somatostatin Receptor Type 2 (SST2)-Expressing Neuroendocrine Neoplasms (NENs) and Other SST2-Expressing Solid Tumors
Study Description:
The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with Progressive Metastatic Somatostatin Receptor Type 2 (SST2)-Expressing Neuroendocrine Neoplasms (NENs) and Other SST2-Expressing Solid Tumors. The purpose of this study is to evaluate the safety of an investigational drug, CRN09682, when given at different doses. CRN09682 is an investigational drug. Investigational drug means the drug is being studied in clinical studies to determine if it is safe and effective and it has not been approved for use or for sale in the market.
The study involves receiving the investigational drug, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as being weighed, having your blood drawn, having imaging done, and talking to the study doctor. If you choose to participate, the study will consist of three main parts: screening, study treatment, and follow-up. The screening period is where the study team will see if you are eligible for the study, and it may require more than 1 visit to complete all screening procedures. After screening, if you are deemed eligible for participation, the next step is the treatment period. You will receive the study drug directly into your vein through intravenous infusion (IV) on the first day of each 21-day treatment cycle. Each IV treatment can range from about 30 minutes to 90 minutes, or more. The number of treatment cycles you will have depends on how you tolerate or respond to the study drug or if you meet other study stopping criteria. The visit at the end of treatment will take place within 7 days after the last dose of study drug, and a safety follow-up visit will take place 30 days after stopping the study drug. If you are no longer getting treatment with the study drug and are still on the study, you will be asked to come into the site for follow-up visits every 3 months to check on your cancer and health status.
The study drug, CRN09682, will be provided by the study 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: clinicaltrials.gov/study/NCT07129252