A Study of NEOK002, an EGFR and MUC1 Targeting Bispecific ADC, in Participants With Select Solid Tumors

May 28, 2026 updated by: NEOK Bio, Inc.

A Study of NEOK002, an EGFR and MUC1 Targeting Bispecific Antibody-Drug, Conjugate in Participants With Select Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a FIH, Phase 1, open-label, multicenter, multiple-dose, dose escalation and expansion study. This study includes 2 parts: a Dose Escalation and Backfill portion (Part A) and a Dose Expansion portion (Part B). NEOK001 is a bispecific EGFR and MUC1 exatecan antibody-drug conjugate (ADC) that will be administered intravenously once every cycle.

Study Type

Interventional

Enrollment (Estimated)

155

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Not yet recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Phone Number: 646-888-4167
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Not yet recruiting
        • SCRI Oncology Partners
        • Contact:
    • Texas
      • Austin, Texas, United States, 78758
      • Dallas, Texas, United States, 78299
        • Not yet recruiting
        • NEXT Oncology
        • Contact:
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Md Anderson Cancer Center
        • Contact:
          • Phone Number: 713-563-1055
      • Houston, Texas, United States, 77054
      • San Antonio, Texas, United States, 75039
    • Virginia
      • Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation
NEOK002
Drug: NEOK002
Escalating doses of NEOK002
Experimental: Dose Expansion
Recommended Dose of NEOK002 for Expansion
Drug: NEOK002 RDE
Recommended NEOK002 dose(s) for Expansion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A: Incidence and Severity of Dose-Limiting Toxicities (DLTs)
Time Frame: 21 days
Incidence and severity of DLTs during the first cycle of treatment in Part A
21 days
Part A: Incidence and Severity of Adverse Events (AEs)
Time Frame: 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
Through study completion, estimated as 32 months
Part B: Investigator Assessment of Objective Response Rate (ORR)
Time Frame: Through study completion, estimated as 32 months
Percentage of patients who achieve a confirmed objective response (ORR)
Through study completion, estimated as 32 months
Part B: Duration of Response (DOR)
Time Frame: Through study completion, estimated as 32 months
The time from the first documentation of tumor response (complete or partial) until disease progression or death.
Through study completion, estimated as 32 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part B: Incidence of AEs
Time Frame: Through study completion, estimated as 32 months
Incidence of TEAEs and SAEs in participants in Part B
Through study completion, estimated as 32 months
Maximum Concentration (Cmax) of NEOK002
Time Frame: 21 days
Assessment of plasma pharmacokinetics (PK) parameters of NEOK002: Cmax
21 days
Terminal Elimination Half Life (T1/2) of NEOK002
Time Frame: 21 days
Assessment of plasma PK parameters of NEOK002: T1/2
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NEOK Bio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

May 21, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • NEOK002-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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