Clear Cell Renal Cell CarcinomaPhase 1NCT07300241
Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
A Phase 1 study testing NEO-811 in people with Clear Cell Renal Cell Carcinoma and Renal Cell Carcinoma, run by Neomorph, Inc at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma, RCC
- What is being tested?
- NEO-811
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 14 sitesUnited States
- Study dates
- 19 Dec 2025to Sep 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
NEO-811 Cleveland Site
Cleveland, Ohio, 44106
- Recruiting
NEO-811 Dallas Site
Dallas, Texas, 75039
- Recruiting
NEO-811 Los Angeles Site
Duarte, California, 91010
- Recruiting
NEO-811 Virginia Site
Fairfax, Virginia, 22031
- Recruiting
NEO-811 Grand Rapids Site
Grand Rapids, Michigan, 49503
- Recruiting
NEO-811 Houston Site
Houston, Texas, 77054
- Recruiting
NEO-811 Long Island Site
Lake Success, New York, 11042
- Recruiting
NEO-811 Florida Site
Miami, Florida, 33136
- Recruiting
NEO-811 South Carolina Site
Myrtle Beach, South Carolina, 29572
- Recruiting
NEO-811 Connecticut Site
New Haven, Connecticut, 06520
- Recruiting
NEO-811 NYC Site
New York, New York, 10065
- Recruiting
NEO-811 Omaha Site
Omaha, Nebraska, 68130
- Recruiting
NEO-811 San Diego Site
San Diego, California, 92037
- Recruiting
NEO-811 Chicago Site
Zion, Illinois, 60099
About this study
Official title: 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
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, VHL-Associated Clear Cell Renal Cell Carcinoma
- Being tested
- NEO-811
- Keywords
- ccRCC, Renal Cell Carcinoma, Clear Cell Renal Cell Carcinoma, VHL, Kidney Cancer
- Medical subject headings
- Carcinoma, Renal Cell, Clear-cell metastatic renal cell carcinoma, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEO-811Drug
NEO-811
| Study group | Role | What they receive |
|---|---|---|
| Single agent NEO-811 dose escalation | Experimental | NEO-811 Receives: Drug: NEO-811 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Maximum observed plasma concentration (Cmax) of NEO-811 will be determined.
Measured: 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.
Trough observed plasma concentration (Ctrough) of NEO-811 will be determined.
Measured: Start of Cycle 1 until Day 1 of last treatment cycle (each treatment cycle is 21 days).
Time to Cmax (Tmax) of NEO-811.
Time to Cmax (Tmax) of NEO-811 will be determined.
Measured: 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.
Area under the concentration time curve (AUC) of NEO-811 will be determined.
Measured: 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.
Tumor response will be determined by RECISTv1.1.
Measured: Start of Cycle 1 until documented disease progression or death, etc. (each treatment cycle is 21 days), estimated as 6-9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start19 Dec 2025
- Primary completionJan 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neomorph, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Klaus Wagner, MD, PhD, Study director, Neomorph, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300241
- Sponsor's protocol ID
- NEO-811-101
- Status last verified
- Oct 2026
- First submitted
- 10 Dec 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No