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

RECRUITINGPHASE1

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

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

NCT07300241•Neomorph, Inc

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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,
+4 more criteria

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.

Locations (7)

NEO-811 Grand Rapids Site

Grand Rapids, Michigan, United States

NEO-811 Long Island Site

Lake Success, New York, United States

NEO-811-101 NYC Site

New York, New York, United States

NEO-811 South Carolina Site

Myrtle Beach, South Carolina, United States

NEO-811 Dallas Site

Dallas, Texas, United States

NEO-811 Houston Site

Houston, Texas, United States

NEO-811 Virginia Site

Fairfax, Virginia, United States

Key Dates

Start Date

December 19, 2025

Primary Completion Date

January 1, 2027

Completion Date

September 1, 2027

Last Updated

March 11, 2026

Enrollment

ESTIMATED participants

Conditions

Clear Cell Renal Cell CarcinomaRenal Cell CarcinomaRCCClear Cell Renal Cell Carcinoma MetastaticccRCCVHL-Associated Clear Cell Renal Cell CarcinomaVHL-Associated Renal Cell CarcinomaKidney Cancer MetastaticKidney Cancers

Interventions

NEO-811

DRUG

Contacts

Sara Weymer

CONTACT

+1 858-428-9800 clinicaltrials@neomorph.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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