Actively Recruiting
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
Led by ALX Oncology Inc. · Updated on 2026-05-12
170
Participants Needed
8
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ALX2004, an antibody drug conjugate targeting EGFR, in adults with advanced or metastatic selected solid tumors including non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, and colorectal cancer. This Phase 1, open-label, multicenter study aims to find the appropriate dose and assess safety and response in participants who have previously received treatment for these cancers. The study is sponsored by ALX Oncology Inc. and plans to enroll up to 170 patients. The study includes three parts: Phase 1a Dose Escalation with increasing doses of ALX2004 to find a safe dose, Phase 1a Dose Exploration where selected doses are further tested in specific tumor types, and Phase 1b Dose Expansion where the recommended dose is given to more patients. ALX2004 is given by intravenous infusion, and dosing is adjusted depending on the study phase and tumor type. Participants will have regular assessments including safety monitoring for dose limiting toxicities and adverse events, tumor response evaluations using RECIST criteria, and measurement of drug levels in the blood. Follow-up can last up to two years from the first dose. The study records outcomes like overall response rate, progression-free survival, and overall survival to understand ALX2004's effects. The total duration of participation depends on the treatment phase and follow-up period.
CONDITIONS
Brief Title
A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with locally advanced, recurrent, or metastatic histologically confirmed head and neck squamous cell carcinoma, non-small cell lung cancer, esophageal squamous cell carcinoma, or colorectal cancer not suitable for curative surgery
- For Dose Escalation: Participants with relapsed or progressed disease after prior anticancer therapy in advanced/metastatic setting with no approved or standard therapy available
- For Dose Exploration and Expansion: Specific tumor criteria including limited prior lines of therapy as detailed for each cancer type
- Adequate bone marrow, renal, and liver function
- Adequate performance status
You will not qualify if you...
- Participants with disease suitable for local therapy with curative intent
- Life expectancy less than 3 months or rapidly progressing disease based on investigator's opinion
- Prior treatment with antibody drug conjugates containing an active TOP1 inhibitor-based component
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years from first dose
Participants receive ALX2004, an antibody drug conjugate targeting EGFR, administered by intravenous infusion during dose escalation, dose exploration, and dose expansion phases.
Visits occur during dosing and monitoring throughout treatment
Duration - Up to 2 years from first dose
Participants are followed for safety and treatment response assessments after treatment administration.
Regular visits for safety and efficacy assessments
Trial Site Locations
Total: 8 locations
1
ALX Center 7
Tampa, Florida, United States, 33612
Actively Recruiting
2
ALX Center 8
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
3
ALX Center 3
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
4
ALX Center 6
Portland, Oregon, United States, 97213
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5
ALX Center 5
Houston, Texas, United States, 77030
Actively Recruiting
6
ALX Center 4
West Valley City, Utah, United States, 84119
Actively Recruiting
7
ALX Center 2
Fairfax, Virginia, United States, 22031
Actively Recruiting
8
ALX Center 1
Spokane, Washington, United States, 99208
Actively Recruiting
Research Team
A
Athanasios Tsiatis, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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