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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

Sponsor: NEOK Bio, Inc. · Participants: 155 · Started: Apr 21, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07612176

Locations in the U.S.

New YorkMemorial Sloan Kettering Cancer Center, New York
TennesseeSCRI Oncology Partners, Nashville
TexasNEXT Oncology, Austin
NEXT Oncology, Dallas
SCRI at Mary Crowley, Dallas
MD Anderson Cancer Center, Houston
NEXT Oncology, Houston
NEXT Oncology, San Antonio
VirginiaNEXT Oncology, Fairfax

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.