A Study of NEOK002, an EGFR and MUC1 Targeting Bispecific ADC, in Participants With Select Solid Tumors

Part of paid clinical trials in Orlando, Florida.

Sponsor
NEOK Bio, Inc.
Study ID
NCT07612189
Phase
PHASE1
Status
Recruiting
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Conditions

  • Locally Advanced (Unresectable) or Metastatic Solid Tumors

Eligibility Criteria

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

Interventions

  • NEOK002 — DRUG
    Escalating doses of NEOK002
  • NEOK002 RDE — DRUG
    Recommended NEOK002 dose(s) for Expansion

Study Details

This is a first in human (FIH), Phase 1 dose escalation and expansion study in select solid tumors. This study includes 2 parts: a Dose Escalation and Backfill portion (Part A) and a Dose Expansion portion (Part B).

Key Dates

First listed
May 28, 2026
Start date
Apr 22, 2026
Status verified
Aug 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
155 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    NEOK002
  • Experimental: Dose Expansion
    Recommended Dose of NEOK002 for Expansion

Primary Outcome Measure

Part A: Incidence and Severity of Dose-Limiting Toxicities (DLTs) [ Time Frame: 21 days ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Sarah Cannon Research Institute at Florida Cancer Specialists- Lake Nona DDUOrlandoFlorida32827
904-380-2410
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
646-888-4167
Sarah Cannon Research Institute Oncology PartnersNashvilleTennessee37203
Tracey Zimmer
[email protected]
972-566-3000
NEXT OncologyAustinTexas78758
Heather Watson
[email protected]
737-610-5202
NEXT OncologyDallasTexas78299
Mofopefoluwa "Fope" Akinwale
[email protected]
972-893-8800
Sarah Cannon Research Institute at Mary CrowleyDallasTexas75230
972-566-3000
MD Anderson Cancer CenterHoustonTexas77030
713-563-1055
NEXT OncologyHoustonTexas77054
Emma Morales
[email protected]
832-384-7912
NEXT OncologySan AntonioTexas75039
Jordan Georg
[email protected]
210-580-9521
NEXT OncologyFairfaxVirginia22031
Maybelle De La Rosa
[email protected]
703-783-4518

Find similar trials in Orlando, FL

By research site
Sarah Cannon Research Institute at Florida Cancer Specialists- Lake Nona DDU· Orlando, FLMemorial Sloan Kettering Cancer Center· New York, NYSarah Cannon Research Institute Oncology Partners· Nashville, TNNEXT Oncology· Austin, TXNEXT Oncology· Dallas, TXSarah Cannon Research Institute at Mary Crowley· Dallas, TX

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