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
Locations
8Sponsors and collaborators
ALX Oncology Inc.
Lead sponsor