Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1interventionalRules rewrite

Phase 1: testing NEO-811 for 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 this drug alone.

Official registry: https://clinicaltrials.gov/study/NCT07300241 · Neomorph, Inc · enrollment listed as 30

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are NEO-811. The registry lists allocation as na. 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.

They plan to enroll about 30 people at 16 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: NEO-811

Primary outcome (registry wording): Frequency and severity of treatment emergent adverse events (TEAEs) of NEO-811 as a single agent.

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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:

Public study contact (from the registry)

Sara Weymer

+1 858-428-9800

clinicaltrials@neomorph.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

16 listed

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FAQ about this NCT record

Is NCT07300241 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07300241?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07300241?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary