A Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific ADC in Participants With Select Solid Tumors
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
- Locally Advanced (Unresectable) or Metastatic Solid Tumors
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- NEOK Bio, Inc.
- Enrolment target
- 155
- Started
- 21 April 2026
- Main results due
- January 2029
- Study sites
- 9
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the 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.
What this study is about
In the sponsor’s own words, from the registry.
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).
Study sites(9)
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Recruiting
SCRI Oncology Partners
Nashville, Tennessee, United States
Recruiting
NEXT Oncology
Austin, Texas, United States
Recruiting
NEXT Oncology
Dallas, Texas, United States
Recruiting
SCRI at Mary Crowley
Dallas, Texas, United States
Recruiting
MD Anderson Cancer Center
Houston, Texas, United States
Recruiting
NEXT Oncology
Houston, Texas, United States
Recruiting
NEXT Oncology
San Antonio, Texas, United States
Recruiting
NEXT Oncology
Fairfax, Virginia, United States
Recruiting
Showing 9 of 9 sites. 9 of the 9 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07612176. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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