RecruitingPhase 1NCT07612176

A Phase 1 Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific ADC in Participants With Select Solid Tumors

A Phase 1 Dose Escalation and Expansion Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific Antibody-Drug Conjugate, in Participants With Select, Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors

Sponsor

NEOK Bio, Inc.

Enrollment

155 participants

Start Date

Apr 21, 2026

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Unresectable or Metastatic Solid Tumors

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called NEOK001 and a drug called NEOK001 RDE for people with locally advanced unresectable or metastatic solid tumors. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNEOK001

Escalating doses of NEOK001

DRUGNEOK001 RDE

Recommended Dose of NEOK001 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

View Full Details on ClinicalTrials.gov

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NCT07612176

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