An Open-Label, First-in-Human, Phase I/II Dose Escalation and Expansion Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
Study Identifier:
NEO-811-101
CT.gov Identifier:
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
Recruiting
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Study Summary
The NEO-811-101 study is an open-label, first-in-human, Phase 1/2 dose escalation and expansion study of NEO-811 for subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma. The study will test NEO-811 initially as a monotherapy.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I/II
Sex
Female & Male
Age
18+ years
Study Drug
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
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.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Emerson Lim
Status
Recruiting
Condition(s) Treated at Site
Renal
Location
START New York (Long Island)
Lake Success, NY, United States, 11042
Investigator
Geraldine O'Sullivan Coyne
Status
Will Be Recruiting
Condition(s) Treated at Site
Renal
Location
START Carolinas
Myrtle Beach, SC, United States, 29572
Investigator
Neal Shore
Status
Will Be Recruiting
Condition(s) Treated at Site
Renal