Recruiting
Phase 1

NEO-811

Sponsor:

Neomorph, Inc

Code:

NCT07300241

Conditions

Clear Cell Renal Cell Carcinoma

Renal Cell Carcinoma

RCC

Clear Cell Renal Cell Carcinoma Metastatic

ccRCC

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NEO-811

Study Details

Brief summary:

The NEO-811-101 study is an open-label, first-in-human, Phase 1/2 dose escalation and expansion study testing NEO-811, an ARNT molecular glue degrader, in 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

Study ID

NCT07300241

Start date

Dec 19, 2025

Status verified date

Jul, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single agent NEO-811 dose escalation

NEO-811

Interventions

NEO-811

NEO-811

Primary outcome measure

  • Frequency and severity of treatment emergent adverse events (TEAEs) of NEO-811 as a single agent. [ Time Frame: 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. [ Time Frame: Start of Cycle 1 until at least 30 days following the last dose of the last treatment cycle (each treatment cycle is 21 days). ]

Central Contacts and Locations

Central contacts

Sara Weymer

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

Locations

NEO-811 Los Angeles Site

Recruiting

Duarte, California, United States, 91010

NEO-811 San Diego Site

Recruiting

San Diego, California, United States, 92037

NEO-811 Connecticut Site

Recruiting

New Haven, Connecticut, United States, 06520

NEO-811 Chicago Site

Recruiting

Zion, Illinois, United States, 60099

NEO-811 Grand Rapids Site

Recruiting

Grand Rapids, Michigan, United States, 49503

NEO-811 Omaha Site

Recruiting

Omaha, Nebraska, United States, 68130

NEO-811 Long Island Site

Recruiting

Lake Success, New York, United States, 11042

NEO-811 NYC Site

Recruiting

New York, New York, United States, 10065

NEO-811 South Carolina Site

Recruiting

Myrtle Beach, South Carolina, United States, 29572

NEO-811 Dallas Site

Recruiting

Dallas, Texas, United States, 75039

NEO-811 Houston Site

Recruiting

Houston, Texas, United States, 77054

NEO-811 Virginia Site

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Neomorph, Inc

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Neomorph, Inc on 2026-08-03.