Recruiting NCT07300241
Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NEO-811.
- Who it may be relevant to
- Registry conditions: Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma, RCC, Clear Cell Renal Cell Carcinoma Metastatic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug NEO-811
NEO-811
Primary outcome measures
- Frequency and severity of treatment emergent adverse events (TEAEs) of NEO-811 as a single agent. [Time frame: Start of Cycle 1 until at least 30 days following the last dose of the last treatment cycle (each treatment cycle is 21 days).]
- Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of NEO-811 as a single agent. [Time frame: Start of Cycle 1 until at least 30 days following the last dose of the last treatment cycle (each treatment cycle is 21 days).]
Secondary outcome measures (5)
- Maximum observed plasma concentration (Cmax) of NEO-811. [Time frame: Start of Cycle 1 until Day 1 of last treatment cycle (each treatment cycle is 21 days).]
- Trough observed plasma concentration (Ctrough) of NEO-811. [Time frame: Start of Cycle 1 until Day 1 of last treatment cycle (each treatment cycle is 21 days).]
- Time to Cmax (Tmax) of NEO-811. [Time frame: Start of Cycle 1 until Day 1 of last treatment cycle (each treatment cycle is 21 days).]
- Area under the concentration time curve (AUC) of NEO-811. [Time frame: Start of Cycle 1 until Day 1 of last treatment cycle (each treatment cycle is 21 days).]
- Anti-tumor activity of NEO-811 as a single agent. [Time frame: Start of Cycle 1 until documented disease progression or death, etc. (each treatment cycle is 21 days), estimated as 6-9 months.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 12 centers
- NEO-811 Los Angeles Site — Duarte
- NEO-811 San Diego Site — San Diego
- NEO-811 Connecticut Site — New Haven
- NEO-811 Chicago Site — Zion
- NEO-811 Grand Rapids Site — Grand Rapids
- NEO-811 Omaha Site — Omaha
- NEO-811 Long Island Site — Lake Success
- NEO-811 NYC Site — New York
- … and 4 more centers
Identifiers
NCT: NCT07300241 · NEO-811-101