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
ALX Oncology Inc.
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
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugALX2004
ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV Infusion
- DrugALX2004
ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion
- DrugALX2004
ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion
Locations (7)
- ALX Center 7Tampa, Florida
- ALX Center 3Grand Rapids, Michigan
- ALX Center 6Portland, Oregon
- ALX Center 5Houston, Texas
- ALX Center 4West Valley City, Utah
- ALX Center 2Fairfax, Virginia