A 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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dose Escalation |
|
|
|
Experimental Expansion |
|
Recruiting Locations
Memorial Sloan Kettering Cancer Center
New York, New York 10065
New York, New York 10065
SCRI Oncology Partners
Nashville, Tennessee 37203
Nashville, Tennessee 37203
NEXT Oncology
Dallas, Texas 75039
Dallas, Texas 75039
MD Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
NEXT Oncology
Fairfax, Virginia 22031
Fairfax, Virginia 22031
More Details
- Status
- Recruiting
- Sponsor
- NEOK Bio, Inc.
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.