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

What this Trial Is About

Researchers are evaluating CRN09682 in a Phase 1/2, multicenter, open-label study focused on participants with neuroendocrine neoplasms (NENs) and other solid tumors that express somatostatin receptor type 2 (SST2). The study aims to assess the safety, tolerability, pharmacokinetics (PK), and early antitumor activity of CRN09682. This includes identifying the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) in a Dose Escalation Phase, followed by further safety and efficacy assessment at an expansion dose. Participants will receive multiple dose levels of CRN09682 given intravenously every three weeks. The study includes several groups based on tumor type, including pancreatic neuroendocrine tumors, non-pancreatic neuroendocrine tumors, neuroendocrine carcinoma, and other solid tumors. After determining the MTD, additional participants will be enrolled to receive the expansion dose to continue evaluation of safety, tolerability, pharmacokinetics, and antitumor effects. During the study, participants will undergo monitoring for adverse events, dose-limiting toxicities, and pharmacokinetic measurements at Day 1 of each 21-day cycle, continuing up to two years. Researchers will assess tumor response using RECIST 1.1 criteria, somatostatin receptor imaging, and progression-free survival. Safety and tolerability will be closely followed, including assessments of interruptions and serious adverse events. The total participation duration may last approximately two years with regular evaluations throughout.

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