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A Study of NEOK002 for Select Solid Tumors

This study is testing a new treatment called NEOK002 for people with locally advanced (meaning it can't be removed by surgery) or metastatic (spread to other parts of the body) solid tumors. NEOK002 is an antibody-drug conjugate (ADC), which is like a targeted delivery system that brings a powerful drug directly to cancer cells. It targets two specific proteins often found on cancer cells, EGFR and MUC1. We are looking for people aged 18 or older who have certain types of solid tumors for which standard treatments are no longer an option. You would need to have at least one measurable tumor and a good general health status (ECOG performance status of 0 or 1). The main goals are to see how safe NEOK002 is at different doses and how well it shrinks tumors. This study is currently in its early stages, a "first-in-human" Phase 1 study, and is open to new participants.

Study design
This is a Phase 1, open-label study, meaning both you and the study team will know which treatment you are receiving. It involves two parts: a dose escalation phase to find the right dose, and a dose expansion phase to further test that dose. The study plans to enroll about 155 participants.
What's involved
NEOK002 will be given through a vein (intravenously) once every treatment cycle. The study will measure side effects for about 32 months.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects and tumor response through study completion, which is estimated to be about 32 months.

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

NCT07612189

A Study of NEOK002, an EGFR and MUC1 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:NEOK002NEOK002 RDE

At a glance

Recruiting sites
10 of 10 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

Explore related trials

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Where it's being run

10 sites across 5 states
Texas6
Florida1
New York1
Tennessee1
Virginia1

Who to contact

Beth Lepping, RN, BSN, MS
[email protected]
please use email
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 metatstatic 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.
Participant 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 patients in Part A

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

    Percentage of patients 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.