NEOK001: a new B7-H3 and ROR1-targeting cancer treatment given by IV infusion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, Phase 1 trial with dose-escalation and expansion parts to evaluate NEOK001, a bispecific B7-H3 x ROR1 exatecan antibody-drug conjugate, in select solid tumors. The study is open-label, multicenter, and will administer NEOK001 intravenously in cycles with multiple-dose regimens. Participants must have measurable disease, ECOG 0-1, and adequate organ function, with tumor tissue available for analysis. Key exclusions include prior ADCs with topoisomerase I payloads and active CNS disease or interstitial lung disease requiring steroids. The trial aims to identify a recommended dose and characterize safety, pharmacokinetics, and preliminary anti-tumor activity.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Study coordinator: Willie J Hudson, MS
• Email: whudson@neokbio.com
• Phone: 615-507-4263

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.