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

Checked against the public recordLast updated May 12, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhasePhase 1
U.S. locations8
SponsorALX Oncology Inc.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
ALX Oncology Inc.
Interventions being studied
Drug: ALX2004; Drug: ALX2004; Drug: ALX2004
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Participants with locally advanced, recurrent or metastatic histologically confirmed HNSCC, NSCLC, ESCC, CRC; locally advanced or recurrent disease must not be amenable to resection with curative intent 1. Dose Escalation: Participants who have relapsed or progressed following prior anticancer therapy in the advanced/metastatic setting and for whom no approved or standard therapy is available. 2. Dose Exploration and Dose Expansion: The following tumor-specific criteria also apply. These cohorts will include all or a subset of these tumors. HNSCC - Received no more than 3 prior lines of therapy in the advanced or metastatic setting NSCLC - For participants with a targetable molecular alteration: received appropriate standard targeted therapy and no more than 2 prior lines of systemic chemotherapy in the advanced/metastatic setting. For participants without a targetable molecular alteration: received platinum-based chemotherapy and CPI (in combination or separately), and have received no more than 2 prior lines of systemic chemotherapy in the advanced/metastatic setting ESCC - Received no more than 3 prior lines of therapy in the advanced/metastatic setting CRC - For participants with a targetable molecular alteration (including dMMR or MSI-H): Received appropriate standard therapy for the alteration, at least 2 prior lines of systemic chemotherapy, and no more than 4 prior lines of therapy in the advanced/metastatic setting. For participants without a targetable molecule alteration: Received at least 2 prior lines of systemic chemotherapy (including an oxaliplatin-based chemotherapy), vascular endothelial growth factor (VEGF)-based therapy, and no more than 4 prior lines of therapy in the advanced/metastatic setting. * Adequate Bone Marrow Function * Adequate Renal \& Liver Function * Adequate Performance Status Exclusion Criteria: * Participants with disease suitable for local therapy with curative intent. * Has a life expectancy of less than 3 months and/or has rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator * Prior treatment with any ADCs that have an active TOP1 inhibitor-based component

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • ALX Center 7Tampa, Florida
  • ALX Center 8Farmington Hills, Michigan
  • ALX Center 3Grand Rapids, Michigan
  • ALX Center 6Portland, Oregon
  • ALX Center 5Houston, Texas
  • ALX Center 4West Valley City, Utah
  • ALX Center 2Fairfax, Virginia
  • ALX Center 1Spokane, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 12, 2026. Always confirm current availability with the study team.

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