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

NCT07085091 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2026-05-12

No results posted yet for this study

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

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

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

Sponsors & Collaborators

  • ALX Oncology Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-18
Primary Completion
2027-06-30
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07085091 on ClinicalTrials.gov