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New treatment option for Locally Advanced (Unresectable) or Metastatic Solid Tumors
Official title A Study of NEOK002, an EGFR and MUC1 Targeting Bispecific ADC, in Participants With Select Solid Tumors
ClinicalTrials.gov ID: NCT07612189
What this study is testing
What is NEOK002?
NEOK002 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced (unresectable) or metastatic solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have locally advanced or metatstatic 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
You likely can't join if
- Participant's most recent systemic anti-cancer treatment was an ADC with a topoisomerase 1-inhibitor payload component.
- Participant with known symptomatic central nervous system (CNS) metastases or any evidence of leptomeningeal disease or evidence of unstable CNS...
- Participants with a known history of interstitial lung disease (ILD) requiring steroid treatment, or for whom suspected ILD cannot be ruled out by...
- Participants with clinically severe pulmonary compromise due to intercurrent pulmonary illness and/or pulmonary disorder requiring supplemental...
- Participants with a QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 msec.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; Nashville, Tennessee, United States; Austin, Texas, United States; Dallas, Texas, United States; Houston, Texas, United States; San Antonio, Texas, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.