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NCT07612189PHASE1Recruiting

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

NEOK Bio, Inc.

Start Date

4/22/2026

Completion Date

2/1/2029

Summary

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).

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

NEOK002

DRUG

NEOK002 RDE

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Conditions

Locally Advanced (Unresectable) or Metastatic Solid Tumors

Locations

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

NEXT Oncology

Austin, Texas 78758

United States

NEXT Oncology

Dallas, Texas 78299

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

NEXT Oncology

Houston, Texas 77054

United States

NEXT Oncology

San Antonio, Texas 75039

United States

NEXT Oncology

Fairfax, Virginia 22031

United States