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
NEOK Bio, Inc.
155 participants
Apr 21, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- Participants must have locally advanced or metastatic 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 Criteria5
- Participant's most recent systemic anti-cancer treatment was an ADC with a topoisomerase 1-inhibitor payload component.
- Participants 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.
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Interventions
Escalating doses of NEOK001
Recommended Dose of NEOK001 for Expansion
Locations(8)
View Full Details on ClinicalTrials.gov
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NCT07612176