About this trial

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

Eligibility criteria

Qualifiers

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

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.

Dose Exploration and Dose Expansion: The following tumor-specific criteria also apply. These cohorts will include all or a subset of these tumors.

Adequate Bone Marrow Function

Disqualifiers

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

Trial design

Treatments tested in this trial

  • ALX2004
  • ALX2004
  • ALX2004

Treatment groups

170 Participants
are divided into 3 treatment groups

Locations

8
Florida
ALX Center 733612, Tampa United States
Michigan
ALX Center 848334, Farmington Hills United States
ALX Center 349546, Grand Rapids United States
Oregon
ALX Center 697213, Portland United States

Sponsors and collaborators

ALX Oncology Inc.

Lead sponsor