A Phase 12 Study of CRN09682 to Evaluate Safety and Effectiveness in Adults With SST2-Expressing Neuroendocrine Tumors and Other Solid Tumors

What this Trial Is About

Researchers are investigating CRN09682 in a Phase 12 study to evaluate its safety, tolerability, pharmacokinetics, and early antitumor effects in adults with SST2-expressing neuroendocrine neoplasms NENs and other solid tumors. This first-in-human, multicenter, open-label trial aims to find the maximum tolerated dose MTD and dose-limiting toxicities DLTs through a dose escalation phase. Following this, an expansion phase will further assess safety and effectiveness at the identified dose. Participants will receive CRN09682 intravenously at multiple dose levels every three weeks during the dose escalation phase to determine the MTD and DLTs. Afterward, additional participants will be enrolled in the dose expansion phase at the established dose to continue evaluating safety, tolerability, pharmacokinetics, and antitumor activity. The study includes cohorts with different neuroendocrine tumor types and other SST2-expressing solid tumors. During the study, participants will be monitored for adverse events, dose interruptions, and pharmacokinetic measurements such as drug concentration and exposure levels. Tumor response will be assessed using RECIST 1.1 criteria and somatostatin receptor imaging over approximately two years. Safety follow-up visits will occur up to 30 days after the last dose, with ongoing evaluations for disease progression and overall response throughout the study period.

A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing NENs and Other Solid Tumors