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NCT07612176From ClinicalTrials.govRecruiting

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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A Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific ADC in Participants With Select Solid Tumors | Trialion