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

Part of paid clinical trials in Duarte, California.

Sponsor
Neomorph, Inc
Study ID
NCT07300241
Phase
PHASE1
Status
Recruiting
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Conditions

  • Clear Cell Renal Cell Carcinoma
  • Clear Cell Renal Cell Carcinoma Metastatic
  • Kidney Cancer Metastatic
  • Kidney Cancers
  • RCC
  • Renal Cell Carcinoma
  • VHL-Associated Clear Cell Renal Cell Carcinoma
  • VHL-Associated Renal Cell Carcinoma
  • ccRCC

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NEO-811 — DRUG
    NEO-811

Study Details

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.

Key Dates

Start date
Dec 19, 2025
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Single agent NEO-811 dose escalation
    NEO-811

Primary Outcome Measure

Frequency and severity of treatment emergent adverse events (TEAEs) of NEO-811 as a single agent. [ Time Frame: Start of Cycle 1 until at least 30 days following the last dose of the last treatment cycle (each treatment cycle is 21 days). ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
NEO-811 Los Angeles SiteDuarteCalifornia91010-
NEO-811 San Diego SiteSan DiegoCalifornia92037-
NEO-811 Chicago SiteZionIllinois60099-
NEO-811 Grand Rapids SiteGrand RapidsMichigan49503-
NEO-811 Long Island SiteLake SuccessNew York11042-
NEO-811 NYC SiteNew YorkNew York10065-
NEO-811 South Carolina SiteMyrtle BeachSouth Carolina29572-
NEO-811 Dallas SiteDallasTexas75039-
NEO-811 Houston SiteHoustonTexas77054-
NEO-811 Virginia SiteFairfaxVirginia22031-

Find similar trials in Duarte, CA

By condition
Kidney cancer
By specialty
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By research site
NEO-811 Los Angeles Site· Duarte, CANEO-811 San Diego Site· San Diego, CANEO-811 Chicago Site· Zion, ILNEO-811 Grand Rapids Site· Grand Rapids, MINEO-811 Long Island Site· Lake Success, NYNEO-811 NYC Site· New York, NY

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