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A Phase 1 Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific ADC in Participants With Select Solid Tumors

NCT07612176 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2026-05-28

No results posted yet for this study

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

NEOK001

Escalating doses of NEOK001

DRUG

NEOK001 RDE

Recommended Dose of NEOK001 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
2026-04-21
Primary Completion
2029-01-31
Completion
2029-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07612176 on ClinicalTrials.gov