A Phase 1 Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific ADC in Participants With Select Solid Tumors
Part of paid clinical trials in New York, New York.
- Sponsor
- NEOK Bio, Inc.
- Study ID
- NCT07612176
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Locally Advanced (Unresectable) or Metastatic Solid Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- NEOK001 — DRUGEscalating doses of NEOK001
- NEOK001 RDE — DRUGRecommended Dose of NEOK001 for Expansion
Study Details
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).
Key Dates
- Start date
- Apr 21, 2026
- Status verified
- May 2026
- Primary completion
- Jan 31, 2029
- Completion
- Jan 31, 2029
Study Design
- Enrollment
- 155 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Dose Escalation
- Experimental: Expansion
Primary Outcome Measure
Part A: Incidence and Severity of Dose-Limiting Toxicities (DLTs) [ Time Frame: 21 Days ]
Central Contacts
- Willie J Hudson, MS615-507-4263
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | |
| NEXT Oncology | Austin | Texas | 78758 | |
| NEXT Oncology | Dallas | Texas | 75039 | |
| MD Anderson Cancer Center | Houston | Texas | 77030 | |
| NEXT Oncology | Houston | Texas | 77054 | |
| NEXT Oncology | San Antonio | Texas | 78299 | |
| NEXT Oncology | Fairfax | Virginia | 22031 |
Find similar trials in New York, NY
Related Studies
- A Study of NEOK002, an EGFR and MUC1 Targeting Bispecific ADC, in Participants With Select Solid TumorsPHASE1 · Recruiting · NEOK Bio, Inc. · New York, New York