Tests NEO-811 in adults with advanced clear cell kidney cancer
Tests NEO-811, a new drug given alone, in adults with advanced kidney cancer.
Plain-language title generated from the registry record
Registry title: Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
Key facts
- Where
- Cincinnati, Cleveland, Dallas, Duarte, Fairfax, Grand Rapids, Houston, Lake Success, Miami, Myrtle Beach, New Haven, New York, Omaha, San Diego, St Louis, and Zion, United StatesSee the 16 sites
- Phase
- Phase 1
Where in United States
- CincinnatiCincinnati, United StatesTaking people
- ClevelandCleveland, United StatesTaking people
- DallasDallas, United StatesTaking people
- DuarteDuarte, United StatesTaking people
- FairfaxFairfax, United StatesTaking people
- Grand RapidsGrand Rapids, United StatesTaking people
- HoustonHouston, United StatesTaking people
- Lake SuccessLake Success, United StatesTaking people
- MiamiMiami, United StatesTaking people
- Myrtle BeachMyrtle Beach, United StatesTaking people
- New HavenNew Haven, United StatesTaking people
- New YorkNew York, United StatesTaking people
- OmahaOmaha, United StatesTaking people
- San DiegoSan Diego, United StatesTaking people
- St LouisSt Louis, United StatesTaking people
- ZionZion, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Neomorph, Inc
- Trial code
- NCT07300241
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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; Formalin-fixed paraffin-embedded (FFPE) tumor tissue, newly obtained or archival, is mandatory for enrollment to the study; Measurable disease as defined by RECIST v1.1; Adequate hematologic, hepatic, and renal function defined as:; Hemoglobin ≥10 g/dL,; Absolute neutrophil count ≥1000 cells/µL,; Platelet count ≥100,000/µL,; AST and ALT ≤2.5 × ULN, or AST and ALT ≤5 × ULN for subjects with liver metastases,; Total bilirubin ≤1.5 × ULN,; Estimated glomerular filtration rate (eGFR) ≥60 mL/min; Subject can swallow oral medications and does not have a condition that could impair the oral bioavailability of the study drug; Other inclusion criteria per protocol.
Exclusion: Prior or concurrent malignancies with exceptions per protocol; Leptomeningeal disease or symptomatic active CNS metastases with exceptions for asymptomatic treated CNS metastases per protocol; History of hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV infection; Non-clear cell predominant RCC histologic subtypes; Other exclusion criteria per protocol.