Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-19

Study Completion Date

2027-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase II Study of AS1411 in Renal Cell Carcinoma

NCT00740441

Metastatic Renal Cell Carcinoma

UNKNOWN PHASE2

Study of MDX-1411 Given Every 14 Days With Pre-medications to Subjects With Clear Cell Kidney Cancer.

NCT00656734

Kidney Cancer

COMPLETED PHASE1

Treatment of Advanced Renal Cell Carcinoma With Quinacrine

NCT00574483

Renal Cell Carcinoma

WITHDRAWN PHASE2

Research Study for Patients With Metastatic Renal Cell Carcinoma

NCT00110344

Carcinoma, Renal Cell

TERMINATED PHASE2

Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy

NCT03055013

Metastatic Renal Cell Carcinoma Sarcomatoid Renal Cell Carcinoma Stage II Renal Cell Cancer AJCC v7 +2 more

ACTIVE_NOT_RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single agent NEO-811 dose escalation

NEO-811

Group Type EXPERIMENTAL

NEO-811

Intervention Type DRUG

NEO-811

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NEO-811

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No