A Phase 1 Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific ADC in Participants With Select Solid Tumors
Start Date
4/21/2026
Completion Date
1/1/2029
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).
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
NEOK001
NEOK001 RDE
Conditions
Locations
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
NEXT Oncology
Austin, Texas 78758
United States
NEXT Oncology
Dallas, Texas 75039
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
NEXT Oncology
Houston, Texas 77054
United States
NEXT Oncology
San Antonio, Texas 78299
United States
NEXT Oncology
Fairfax, Virginia 22031
United States