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

NEOK Bio, Inc.

Status and phase

Enrolling

Phase 1

Conditions

Locally Advanced (Unresectable) or Metastatic Solid Tumors

Treatments

Drug: NEOK001 RDE

Drug: NEOK001

Study type

Interventional

Funder types

Industry

Identifiers

NCT07612176

NEOK001-1

Details and patient eligibility

About

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).

Full 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 B7-H3 x ROR1 exatecan antibody-drug conjugate (ADC) that will be administered intravenously once every cycle.

Enrollment

155 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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.