Health Trials

Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma

ConditionsClear Cell Renal Cell CarcinomaRenal Cell CarcinomaRCCClear Cell Renal Cell Carcinoma MetastaticccRCCVHL-Associated Clear Cell Renal Cell CarcinomaVHL-Associated Renal Cell CarcinomaKidney Cancer MetastaticKidney Cancers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNeomorph, Inc

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • NEO-811

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Neomorph, Inc

Lead sponsor

Source ClinicalTrials.gov