A Study of NEOK002, an EGFR and MUC1 Targeting Bispecific ADC, in Participants With Select Solid Tumors
NCT07612189 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 155
Last updated 2026-06-01
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).
Conditions
- Locally Advanced (Unresectable) or Metastatic Solid Tumors
Interventions
- DRUG
-
NEOK002
Escalating doses of NEOK002
- DRUG
-
NEOK002 RDE
Recommended NEOK002 dose(s) for Expansion
Sponsors & Collaborators
-
NEOK Bio, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-22
- Primary Completion
- 2029-02-28
- Completion
- 2029-02-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
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