Actively Recruiting
A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors
Led by ALX Oncology Inc. · Updated on 2026-05-12
170
Participants Needed
8
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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...
- Adults with locally advanced, recurrent, or metastatic head and neck squamous cell carcinoma, non-small cell lung cancer, esophageal squamous cell carcinoma, or colorectal cancer not suitable for curative surgery
- Participants who have relapsed or progressed after prior anticancer therapy with no approved or standard therapy available (dose escalation)
- For head and neck cancer: no more than 3 prior therapies in advanced/metastatic setting
- For non-small cell lung cancer: if targetable mutation, received standard targeted therapy and no more than 2 prior systemic chemotherapies; if no targetable mutation, received platinum-based chemotherapy and checkpoint inhibitors with no more than 2 prior systemic chemotherapies
- For esophageal squamous cell carcinoma: no more than 3 prior therapies in advanced/metastatic setting
- For colorectal cancer: if targetable mutation, received standard therapy and between 2 to 4 prior systemic therapies; if no targetable mutation, received at least 2 systemic chemotherapies including oxaliplatin, VEGF-based therapy, and no more than 4 prior therapies
- Adequate bone marrow, renal, and liver function
- Adequate performance status
You will not qualify if you...
- Disease that can be treated with local therapy aiming for cure
- Life expectancy less than 3 months or rapidly progressing disease such as tumor bleeding or uncontrolled pain
- Prior treatment with antibody drug conjugates containing active TOP1 inhibitor component
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Actively Recruiting
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
CONTACT
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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