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Phase 1 Study of NEOK001 for Advanced Solid Tumors

This Phase 1 study is testing a new treatment called NEOK001 for people with locally advanced (unresectable, meaning it can't be removed by surgery) or metastatic (spread to other parts of the body) solid tumors. NEOK001 is a special type of drug called an antibody-drug conjugate (ADC), which combines an antibody with a chemotherapy drug to target cancer cells more directly. The study aims to find the safest dose of NEOK001 and see how well it works. You might be able to join if you have certain types of advanced solid tumors for which standard treatments are no longer an option, and you are generally well enough to participate. The study plans to enroll about 155 participants. The current status of the study is unclear.

Study design
This is a Phase 1, open-label study, meaning both you and your doctors will know which treatment you are receiving. It is designed to find the right dose and then expand to more participants, with an estimated enrollment of 155 people.
What's involved
NEOK001 will be given intravenously (into a vein) once every cycle. The study will monitor for side effects and how well the treatment works.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for side effects throughout the study, which is estimated to last up to 32 months. The study will also assess how well the treatment works during this time.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07612176

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
NEOK Bio, Inc.
~155 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:NEOK001NEOK001 RDE

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Incidence and Severity of Dose-Limiting Toxicities (DLTs)
Measured over 21 Days
+3 more outcomes measured

Conditions

Locally Advanced (Unresectable) or Metastatic Solid Tumors

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Where it's being run

8 sites across 4 states
Texas5
New York1
Tennessee1
Virginia1

Who to contact

Willie J Hudson, MS
[email protected]
615-507-4263
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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 trial measures

  • Part A: Incidence and Severity of Dose-Limiting Toxicities (DLTs)21 Days

    Incidence and severity of DLTs during the first cycle of treatment in Part A

  • Part A: Incidence and Severity of Adverse Events (AEs)Through study completion, estimated as 32 months

    Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) in participants in Part A

  • Part B: Investigator Assessment of Objective Response Rate (ORR)Through study completion, estimated as 32 months

    Percentage of participants who achieve a confirmed objective response (ORR)

  • Part B: Duration of Response (DOR)Through study completion, estimated as 32 months

    The time from the first documentation of tumor response (complete or partial) until disease progression or death.