NEO-811 for Kidney Cancer

Recruiting at 1 trial location

Overseen By Sara Weymer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Neomorph, Inc

Disqualifiers: Non-clear cell RCC, CNS metastases, HBV, HCV, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 21

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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

My condition worsened after or I refused standard treatments.

I have advanced kidney cancer that cannot be surgically removed.

My doctor believes I have at least 12 weeks to live.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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)

6-9 months

Visits every 21 days per treatment cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of treatment emergent adverse events (TEAEs)

At least 30 days following last dose

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?

Group I: Single agent NEO-811 dose escalation Experimental Treatment 1 Intervention

NEO-811

Who Is Running the Clinical Trial?

Neomorph, Inc

Lead Sponsor