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Phase 1/2 Study of NEO-811 for Clear Cell Renal Cell Carcinoma

This study is testing a new drug called NEO-811 for people with clear cell renal cell carcinoma (a type of kidney cancer) that is advanced, has spread, or cannot be removed by surgery. NEO-811 is an ARNT molecular glue degrader. You might be able to join if your cancer has gotten worse after standard treatments, or if you can't receive standard treatments. The main goals are to see how safe NEO-811 is and to find the best dose. Researchers will also look for side effects. This is a first-in-human study, meaning it's one of the first times NEO-811 is being given to people. The study plans to enroll 30 participants, but its current recruitment status is unclear.

Study design
This is an open-label, first-in-human, Phase 1/2 study, meaning both you and your doctors will know you are receiving NEO-811. It is a dose escalation and expansion study, and it plans to enroll 30 participants.
What's involved
You would receive NEO-811, initially as a single treatment. Each treatment cycle is 21 days, and you would be monitored for side effects from the start of treatment until at least 30 days after your last dose.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for side effects from the start of your first treatment cycle until at least 30 days after your last dose of NEO-811.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07300241

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Neomorph, Inc
~30 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:NEO-811

At a glance

Recruiting sites
12 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency and severity of treatment emergent adverse events (TEAEs) of NEO-811 as a single agent.
Measured over Start of Cycle 1 until at least 30 days following the last dose of the last treatment cycle (each treatment cycle is 21 days).
+1 more outcome measured

Conditions

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

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Clear Cell Renal Cell Carcinoma

NCT07300241

Where you'd take part

This study runs at 12 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • NEO-811 Chicago Site

    Zion, Illinoisno site contact published

    Recruiting

  • NEO-811 Connecticut Site

    New Haven, Connecticutno site contact published

    Recruiting

  • NEO-811 Dallas Site

    Dallas, Texasno site contact published

    Recruiting

  • NEO-811 Grand Rapids Site

    Grand Rapids, Michiganno site contact published

    Recruiting

  • NEO-811 Houston Site

    Houston, Texasno site contact published

    Recruiting

  • NEO-811 Long Island Site

    Lake Success, New Yorkno site contact published

    Recruiting

  • NEO-811 Los Angeles Site

    Duarte, Californiano site contact published

    Recruiting

  • NEO-811 NYC Site

    New York, New Yorkno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Klaus Wagner, MD, PhD · STUDY_DIRECTOR · Neomorph, Inc

Who to contact

Sara Weymer
[email protected]
+1 858-428-9800
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Frequency and severity of treatment emergent adverse events (TEAEs) of NEO-811 as a single agent.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.

  • Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of NEO-811 as a single agent.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.