RecruitingPhase 1NCT07300241

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


Sponsor

Neomorph, Inc

Enrollment

30 participants

Start Date

Dec 19, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called NEO-811 for people with advanced kidney cancer (specifically, clear cell renal cell carcinoma) that has spread or cannot be surgically removed, and whose cancer has progressed after standard treatments. The study is in early phases, looking at safety and the right dose. **You may be eligible if...** - You have locally advanced or metastatic clear cell renal cell carcinoma (a type of kidney cancer) - Your cancer has gotten worse on standard therapies, or you have declined those treatments - You are in good enough overall health (ECOG performance score 0 or 1 — able to carry out daily activities) - Your life expectancy is at least 12 weeks - You have measurable cancer on scans - You can provide a tumor tissue sample (either a new biopsy or an archived sample) **You may NOT be eligible if...** - You have a different subtype of kidney cancer (not clear cell) - You have serious heart, liver, or kidney problems - You have untreated brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNEO-811

NEO-811


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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07300241


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