NCT07085091

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: ALX Oncology Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This study consists of Phase 1a Dose finding, comprising of Dose Escalation portion followed by Dose Exploration, and a Phase 1b Dose Expansion. The study will enroll previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC) and colorectal cancer (CRC). Up to 170 patients are expected to be enrolled in the study.

Conditions

• NSCLC (Advanced Non-small Cell Lung Cancer)
• HNSCC
• CRC (Colorectal Cancer)
• ESCC
• Colo-rectal Cancer
• Head and Neck Cancer
• Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

Type	Name	Description
DRUG	ALX2004	ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV Infusion
DRUG	ALX2004	ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion
DRUG	ALX2004	ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion

Timeline

• Start date: 2025-08-18
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2025-07-25
• Last updated: 2026-02-17

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study