NCT07612176 A Phase 1 Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific ADC in Participants With Select Solid Tumors
| NCT ID | NCT07612176 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | NEOK Bio, Inc. |
| Condition | Locally Advanced (Unresectable) or Metastatic Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 155 participants |
| Start Date | 2026-04-21 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 155 participants in total. It began in 2026-04-21 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Key Inclusion Criteria: * Participants must have locally advanced or metastatic 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. Key Exclusion Criteria: * Participant's most recent systemic anti-cancer treatment was an ADC with a topoisomerase 1-inhibitor payload component. * Participants 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07612176 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locally Advanced (Unresectable) or Metastatic Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07612176 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07612176 currently recruiting?
Yes, NCT07612176 is actively recruiting participants. Contact the research team at whudson@neokbio.com for enrollment information.
Where is the NCT07612176 trial being conducted?
This trial is being conducted at New York, United States, Nashville, United States, Austin, United States, Dallas, United States and 4 additional locations.
Who is sponsoring the NCT07612176 clinical trial?
NCT07612176 is sponsored by NEOK Bio, Inc.. The trial plans to enroll 155 participants.