NEO-811 for Kidney Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called NEO-811 for individuals with advanced kidney cancer that cannot be surgically removed. The goal is to determine the safety and effectiveness of NEO-811 as a solo treatment. The trial seeks participants with clear cell renal cell carcinoma who have not responded to standard treatments and experience symptoms affecting daily life. As a Phase 1 trial, participants will be among the first to receive NEO-811, aiding researchers in understanding how this new treatment works in people.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, since the study tests NEO-811 as a monotherapy (used alone), it's possible that you might need to stop other treatments. Please consult with the trial team for specific guidance.
Is there any evidence suggesting that NEO-811 is likely to be safe for humans?
Researchers are currently studying NEO-811 to assess its safety and determine the appropriate dosage for patients with advanced kidney cancer. As this is an early phase of the clinical trial, limited information exists on patient responses to this treatment. The primary goal at this stage is to evaluate its safety in humans, which involves monitoring any side effects when using NEO-811 alone. Since this is the first human trial of NEO-811, all reactions, both positive and negative, are closely monitored. Currently, there isn't enough data to determine how well patients tolerate it, but these trials are crucial for understanding NEO-811's safety.12345
Why do researchers think this study treatment might be promising?
NEO-811 is unique because it represents a new approach to tackling kidney cancer by targeting specific pathways that existing treatments might not address. While standard treatments like targeted therapies and immunotherapies focus on inhibiting known cancer growth signals or boosting the immune response, NEO-811 introduces a novel active ingredient designed to interfere with cancer progression differently. Researchers are excited about NEO-811's potential to provide an alternative for patients, especially those who might not respond well to current options.
What evidence suggests that NEO-811 might be an effective treatment for kidney cancer?
Research shows that NEO-811 is a new treatment tested for advanced kidney cancer in this trial. Since this is its first trial in humans, information about its effectiveness in people remains limited. NEO-811 specifically targets cancer cells, leading scientists to believe it might effectively combat kidney cancer. Early lab studies demonstrated that NEO-811 can reduce cancer cell growth. While further research is necessary, these initial results are promising and suggest that NEO-811 could become a helpful treatment option.1236
Who Is on the Research Team?
Klaus Wagner, MD, PhD
Principal Investigator
Neomorph, Inc
Are You a Good Fit for This Trial?
This trial is for adults with advanced kidney cancer that can't be surgically removed and who have not responded to or refused standard treatments. They should be relatively healthy (ECOG PS 0 or 1), expected to live at least 12 weeks, and have a sample of their tumor available. Blood counts and liver function tests must meet specific criteria.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation and Expansion
Participants receive NEO-811 as a monotherapy to determine the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of treatment emergent adverse events (TEAEs)
What Are the Treatments Tested in This Trial?
Interventions
- NEO-811
Trial Overview
NEO-811 is being tested in this Phase 1/2 study as a potential new treatment for clear cell renal cell carcinoma. The trial will first assess the safety and proper dose of NEO-811 when used alone in patients with advanced stages of the disease.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
NEO-811
Find a Clinic Near You
Who Is Running the Clinical Trial?
Neomorph, Inc
Lead Sponsor
Citations
Open-Label Phase 1/2 Study of NEO-811 in Subjects With ...
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 ...
NEO-811 for Kidney Cancer
Participants are monitored for safety and effectiveness after treatment, including assessment of treatment emergent adverse events (TEAEs).
Kidney Cancer Highlights from ASCO 2025
After a single dose of ALLO-316, 31% of patients responded to treatment and 4 out of 5 have ongoing response after an average of 7 months and ...
4.
ctv.veeva.com
ctv.veeva.com/study/open-label-phase-1-2-study-of-neo-811-in-subjects-with-locally-advanced-or-metastatic-non-resectableOpen-Label Phase 1/2 Study of NEO-811 in Subjects With ...
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 ...
Open-Label Phase 1/2 Study of NEO-811 in Subjects ...
Outcome Measure, Measure Description, Time Frame. Frequency and severity of treatment emergent adverse events (TEAEs) of NEO-811 as a single agent.
Angiogenesis Inhibitors and Immunomodulation in Renal ...
This review article explores the scientific basis behind drug treatments in kidney cancers, with particular focus on blood vessel development and the immune ...
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