RecruitingPhase 1NCT07085091

A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors

A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants With Advanced or Metastatic Select Solid Tumors


Sponsor

ALX Oncology Inc.

Enrollment

170 participants

Start Date

Aug 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants with Advanced or Metastatic Select Solid Tumors


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing a new experimental drug called ALX2004 in people with advanced or metastatic solid tumors, specifically head and neck cancers, non-small cell lung cancer, esophageal squamous cell cancer, and left-sided colorectal cancer. The goal is to determine a safe dose and assess early signs of effectiveness. **You may be eligible if...** - You have been diagnosed with one of the specific cancers listed above that has spread and cannot be surgically removed - You have already tried standard treatments that have not worked, or no approved options remain - Your overall health is adequate for cancer treatment (ECOG 0 or 1) **You may NOT be eligible if...** - You have active brain metastases - You have significant autoimmune disease requiring treatment - You have had certain prior treatments that disqualify you - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGALX2004

ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV Infusion

DRUGALX2004

ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion

DRUGALX2004

ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion


Locations(7)

ALX Center 7

Tampa, Florida, United States

ALX Center 3

Grand Rapids, Michigan, United States

ALX Center 6

Portland, Oregon, United States

ALX Center 5

Houston, Texas, United States

ALX Center 4

West Valley City, Utah, United States

ALX Center 2

Fairfax, Virginia, United States

ALX Center 1

Spokane, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT07085091


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