An Open-Label, First-in-Human, Phase 1/2 Dose Escalation and Expansion Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma

What this Trial Is About

Researchers are evaluating NEO-811, an ARNT molecular glue degrader, in an open-label, first-in-human Phase 1/2 study for adults with locally advanced or metastatic non-resectable clear cell renal cell carcinoma (ccRCC). The study focuses on patients whose cancer has progressed despite or who have refused standard therapies. This research aims to find the right dose and assess safety and activity of NEO-811 as a single agent. Participants will receive NEO-811 alone in a dose escalation and expansion design to determine the maximum tolerated dose and recommended dose for further studies. Treatment cycles last 21 days each, and dosing begins at Cycle 1. The study does not include a placebo or comparator group. The primary period involves monitoring adverse events and dose tolerance, with secondary assessments including drug plasma levels and anti-tumor activity over approximately 6 to 9 months. During the study, participants will undergo regular evaluations including blood tests to monitor liver, kidney, and blood function, tumor assessments measured by RECIST v1.1 criteria, and tumor tissue collection for analysis. Safety monitoring continues from the start of treatment through at least 30 days after the last dose. Researchers will measure treatment-emergent side effects, drug concentration in blood, and disease progression to understand NEO-811's effects and safety profile.

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