A Study of NEOK002, an EGFR and MUC1 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 metatstatic 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. - Participant 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 Dose Expansion
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dose Escalation |
NEOK002 |
|
|
Experimental Dose Expansion |
Recommended Dose of NEOK002 for Expansion |
|
Recruiting Locations
Sarah Cannon Research Institute at Florida Cancer Specialists- Lake Nona DDU
Orlando, Florida 32827
Orlando, Florida 32827
Contact:
904-380-2410
904-380-2410
Memorial Sloan Kettering Cancer Center
New York, New York 10065
New York, New York 10065
Contact:
646-888-4167
646-888-4167
Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas 75230
Dallas, Texas 75230
Contact:
972-566-3000
972-566-3000
NEXT Oncology
Dallas, Texas 78299
Dallas, Texas 78299
MD Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
Contact:
713-563-1055
713-563-1055
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 EGFR and MUC1 exatecan antibody-drug conjugate (ADC) that will be administered intravenously once every cycle.