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

Purpose

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).

Condition

  • Locally Advanced (Unresectable) or Metastatic Solid Tumors

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Dose Escalation followed by Expansion
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation
  • Drug: NEOK001
    Escalating doses of NEOK001
Experimental
Expansion
  • Drug: NEOK001 RDE
    Recommended Dose of NEOK001 for Expansion

Recruiting Locations

SCRI Oncology Partners
Nashville, Tennessee 37203
Contact:
Tracey Zimmer
972-566-3000
Tracey.Zimmer@scri.com

NEXT Oncology
San Antonio, Texas 78299
Contact:
Jordan Georg
210-580-9521
Jgeorg@nextoncology.com

More Details

Status
Recruiting
Sponsor
NEOK Bio, Inc.

Study Contact

Willie J Hudson, MS
615-507-4263
whudson@neokbio.com

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