Phase 12 Study of NEO-811 for Treating Advanced or Metastatic Clear Cell Renal Cell Carcinoma

What this Trial Is About

This research aims to evaluate NEO-811, a new ARNT molecular glue degrader, in adults with locally advanced or metastatic non-resectable clear cell renal cell carcinoma ccRCC. The study is an open-label, first-in-human Phase 12 trial testing the safety and dosing of NEO-811 as a monotherapy in subjects who have progressed on or refused standard treatments. Participants will receive NEO-811 alone in a dose escalation and expansion format to determine the maximum tolerated dose or recommended Phase 2 dose. Each treatment cycle lasts 21 days, and dosing will continue until disease progression or other criteria for stopping treatment are met. Throughout the study, participants will be monitored for treatment-emergent adverse events and drug plasma levels. Researchers will assess anti-tumor activity, safety, and optimal dosing over an estimated 6 to 9 months. Tumor tissue samples and regular evaluations of blood counts, liver and kidney function, and measurable disease will support ongoing monitoring. Participant involvement may last until at least 30 days after the last treatment dose, with follow-up for safety and response.

Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma