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New hope for advanced kidney cancer: first human trial of NEO-811 begins

NCT ID NCT07300241

Disease control Sponsor: Neomorph, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 4 times

Summary

This early-stage study tests a new drug called NEO-811 in people with advanced clear cell kidney cancer that has spread or cannot be surgically removed. The goal is to find the safest dose and see how well the drug works. About 30 participants who have already tried other treatments or cannot take them will be enrolled.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

clear cell renal carcinoma Clear-cell metastatic renal cell carcinoma hereditary clear cell renal cell carcinoma kidney cancer nonpapillary renal cell carcinoma renal cell carcinoma von Hippel-Lindau disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CCRCC Clear cell renal cell carcinoma Clear cell renal cell carcinoma metastatic Kidney cancer metastatic Kidney cancers RCC Renal cell carcinoma VHL-associated clear cell renal cell carcinoma VHL-associated renal cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    12 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • NEO-811 Chicago Site

    RECRUITING

    Zion, Illinois, 60099, United States

  • NEO-811 Connecticut Site

    RECRUITING

    New Haven, Connecticut, 06520, United States

  • NEO-811 Dallas Site

    RECRUITING

    Dallas, Texas, 75039, United States

  • NEO-811 Grand Rapids Site

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • NEO-811 Houston Site

    RECRUITING

    Houston, Texas, 77054, United States

  • NEO-811 Long Island Site

    RECRUITING

    Lake Success, New York, 11042, United States

  • NEO-811 Los Angeles Site

    RECRUITING

    Duarte, California, 91010, United States

  • NEO-811 NYC Site

    RECRUITING

    New York, New York, 10065, United States

  • NEO-811 Omaha Site

    RECRUITING

    Omaha, Nebraska, 68130, United States

  • NEO-811 San Diego Site

    RECRUITING

    San Diego, California, 92037, United States

  • NEO-811 South Carolina Site

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • NEO-811 Virginia Site

    RECRUITING

    Fairfax, Virginia, 22031, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.