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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

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

ArmDescriptionAssigned Intervention
Experimental
Single agent NEO-811 dose escalation 		NEO-811
  • Drug: NEO-811
    NEO-811

Recruiting Locations

NEO-811 San Diego Site
San Diego, California 92037

NEO-811 Grand Rapids Site
Grand Rapids, Michigan 49503

NEO-811 Long Island Site
Lake Success, New York 11042

NEO-811 NYC Site
New York, New York 10065

NEO-811 South Carolina Site
Myrtle Beach, South Carolina 29572

NEO-811 Dallas Site
Dallas, Texas 75039

NEO-811 Houston Site
Houston, Texas 77054

NEO-811 Virginia Site
Fairfax, Virginia 22031

More Details

Status
Recruiting
Sponsor
Neomorph, Inc

Study Contact

Sara Weymer
+1 858-428-9800
clinicaltrials@neomorph.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.