The NEO-811-101 study is an open-label, first-in-human, Phase 1/2 dose escalation and expansion study testing NEO-811, an ARNT molecular glue degrader, in subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma. The study will test NEO-811 initially as a monotherapy.
Subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma (ccRCC).
Subjects must have progressed on or refused standard therapies.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.
Estimated life expectancy, in the judgment of the Investigator, of at least 12 weeks.
Non-clear cell predominant RCC histologic subtypes.
Leptomeningeal disease or symptomatic active CNS metastases with exceptions for asymptomatic treated CNS metastases per protocol.
Prior or concurrent malignancies with exceptions per protocol.
History of hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV infection.
Neomorph, Inc
Lead sponsor