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A Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific ADC in Participants With Select Solid Tumors
RecruitingPhase 1
A Phase 1 Dose Escalation and Expansion Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific Antibody-Drug Conjugate, in Participants With Select, Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Key Inclusion Criteria: * Participants must have locally advanced or metastatic disease in a select tumor type, for which no standard therapy is available. * Participants must have at least 1 measurable target lesion based on RECIST v1.1. * Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Participants must have adequate hematologic, hepatic, and renal function. * Participants should have available archived tumor tissue from their most recent biopsy. Key Exclusion Criteria: * Participant's most recent systemic anti-cancer treatment was an ADC with a topoisomerase 1-inhibitor payload component. * Participants with known symptomatic central nervous system (CNS) metastases or any evidence of leptomeningeal disease or evidence of unstable CNS metastases, even if asymptomatic. * Participants with a known history of interstitial lung disease (ILD) requiring steroid treatment, or for whom suspected ILD cannot be ruled out by imaging at screening. * Participants with clinically severe pulmonary compromise due to intercurrent pulmonary illness and/or pulmonary disorder requiring supplemental oxygen or any prior pneumonectomy. * Participants with a QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 msec.
About the study
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).
What is being tested
- NEOK001 (drug)
- NEOK001 RDE (drug)
Sponsor: NEOK Bio, Inc. · Participants: 155 · Started: Apr 21, 2026
Contact the study team
- Willie J Hudson, MS · Phone: 615-507-4263
Official record on ClinicalTrials.gov — NCT07612176
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.