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

July 31, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

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.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • NEO-811 Connecticut 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
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • NEO-811 Omaha 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single agent NEO-811 dose escalation
NEO-811
Drug: NEO-811
NEO-811

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Neomorph, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 19, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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