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RECRUITING
NCT07612189
PHASE1

A Phase 1 Study of NEOK002, an EGFR and MUC1 Targeting Bispecific ADC, in Participants With Select Solid Tumors

Sponsor: NEOK Bio, Inc.

View on ClinicalTrials.gov

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).

Official title: A Phase 1 Dose Escalation and Expansion Study of NEOK002, an EGFR and MUC1 Targeting Bispecific Antibody-Drug, Conjugate in Participants With Select Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

155

Start Date

2026-04-22

Completion Date

2029-02

Last Updated

2026-05-28

Healthy Volunteers

No

Interventions

DRUG

NEOK002

Escalating doses of NEOK002

DRUG

NEOK002 RDE

Recommended NEOK002 dose(s) for Expansion

Locations (8)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

NEXT Oncology

Austin, Texas, United States

NEXT Oncology

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

NEXT Oncology

Houston, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

NEXT Oncology

Fairfax, Virginia, United States