Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Criteria
- 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. - Other exclusion criteria per protocol.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Single agent NEO-811 dose escalation |
NEO-811 |
|
Recruiting Locations
NEO-811 San Diego Site
San Diego, California 92037
San Diego, California 92037
NEO-811 Grand Rapids Site
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
NEO-811 Long Island Site
Lake Success, New York 11042
Lake Success, New York 11042
NEO-811 NYC Site
New York, New York 10065
New York, New York 10065
NEO-811 South Carolina Site
Myrtle Beach, South Carolina 29572
Myrtle Beach, South Carolina 29572
NEO-811 Dallas Site
Dallas, Texas 75039
Dallas, Texas 75039
NEO-811 Houston Site
Houston, Texas 77054
Houston, Texas 77054
NEO-811 Virginia Site
Fairfax, Virginia 22031
Fairfax, Virginia 22031
More Details
- Status
- Recruiting
- Sponsor
- Neomorph, Inc