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

May 29, 2026 updated by: Neomorph, Inc

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • NEO-811 Los Angeles Site
      • San Diego, California, United States, 92037
        • Recruiting
        • NEO-811 San Diego Site
    • Illinois
      • Zion, Illinois, United States, 60099
        • Recruiting
        • NEO-811 Chicago Site
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • NEO-811 Grand Rapids Site
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • NEO-811 Long Island Site
      • New York, New York, United States, 10065
        • Recruiting
        • NEO-811 NYC Site
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • NEO-811 South Carolina Site
    • Texas
      • Dallas, Texas, United States, 75039
        • Recruiting
        • NEO-811 Dallas Site
      • Houston, Texas, United States, 77054
        • Recruiting
        • NEO-811 Houston Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEO-811 Virginia Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single agent NEO-811 dose escalation
NEO-811
Drug: NEO-811
NEO-811

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
TEAEs will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 6.0.
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).
The MTD and/or RP2D of NEO-811 as a single agent will be determined.
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

Outcome Measure
Measure Description
Time Frame
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).
Maximum observed plasma concentration (Cmax) of NEO-811 will be determined.
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).
Trough observed plasma concentration (Ctrough) of NEO-811 will be determined.
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).
Time to Cmax (Tmax) of NEO-811 will be determined.
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).
Area under the concentration time curve (AUC) of NEO-811 will be determined.
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.
Tumor response will be determined by RECISTv1.1.
Start of Cycle 1 until documented disease progression or death, etc. (each treatment cycle is 21 days), estimated as 6-9 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neomorph, Inc

Investigators

  • Study Director: Klaus Wagner, MD, PhD, Neomorph, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Actual)

December 23, 2025

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEO-811-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Renal Cell Carcinoma

Clinical Trials on NEO-811

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe