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

NCT07300241 | Recruiting Phase 1 FDA Drug

• 1 other identifier: NEO-811-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

Brief 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.

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

Keywords

ccRCC; Renal Cell Carcinoma; Clear Cell Renal Cell Carcinoma; VHL; Kidney Cancer

Outcome Measures

Primary Outcomes (2)

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

  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.

  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 Outcomes (5)

• Maximum observed plasma concentration (Cmax) of NEO-811.

  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.

  Start of Cycle 1 until Day 1 of last treatment cycle (each treatment cycle is 21 days).

• Time to Cmax (Tmax) of NEO-811.

  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.

  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.

  Start of Cycle 1 until documented disease progression or death, etc. (each treatment cycle is 21 days), estimated as 6-9 months.

Study Arms (1)

Single agent NEO-811 dose escalation

EXPERIMENTAL

NEO-811

Drug: NEO-811

Interventions

NEO-811 DRUG

NEO-811

Single agent NEO-811 dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neomorph, Inc: lead

Study Sites (7)

NEO-811 Grand Rapids Site

Grand Rapids, Michigan, 49503, United States

RECRUITING

NEO-811 Long Island Site

Lake Success, New York, 11042, United States

RECRUITING

NEO-811-101 NYC Site

New York, New York, 10065, United States

RECRUITING

NEO-811 South Carolina Site

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

NEO-811 Dallas Site

Dallas, Texas, 75039, United States

RECRUITING

NEO-811 Houston Site

Houston, Texas, 77054, United States

RECRUITING

NEO-811 Virginia Site

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell; Clear-cell metastatic renal cell carcinoma; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Klaus Wagner, MD, PhD

  Neomorph, Inc

  STUDY DIRECTOR

Central Study Contacts

Sara Weymer

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 23, 2025
• Study Start: December 19, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)