Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
NCT07300241 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-05-19
Summary
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.
Conditions
- Clear Cell Renal Cell Carcinoma
- Renal Cell Carcinoma
- RCC
- Clear Cell Renal Cell Carcinoma Metastatic
- ccRCC
- VHL-Associated Clear Cell Renal Cell Carcinoma
- VHL-Associated Renal Cell Carcinoma
- Kidney Cancer Metastatic
- Kidney Cancers
Interventions
- DRUG
-
NEO-811
NEO-811
Sponsors & Collaborators
-
Neomorph, Inc
lead INDUSTRY
Principal Investigators
-
Klaus Wagner, MD, PhD · Neomorph, Inc
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-19
- Primary Completion
- 2027-01-31
- Completion
- 2027-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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