A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
ALX2004: ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV Infusion
ALX2004: ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion
ALX2004: ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion
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
Eligibility
Primary outcome measure(s)
- Phase 1a: Incidence of dose limiting toxicities (DLTs) — Up to 28 days
Phase 1a: Number and proportion of participants enrolled in the dose escalation phase who experience dose-limiting toxicities (DLTs), received at least one dose of ALX2004 and completed the DLT evaluation - Phase 1a: Incidence of treatment emergent adverse events — Up to 2 years from first dose
Phase 1a: Adverse Events as characterized by type, frequency, severity (NCI CTCAE v5.0), timing, seriousness, and relationship to the study drug in order to establish the RDE. Laboratory abnormalities as characterized by type, frequency, severity and timing - Phase 1b: Overall Response Rate (ORR) per investigator assessment using RECIST v1.1 — Up to 2 years from first patient dosed in dose expansion phase
Phase 1b: ORR is defined as proportion of participants whose BOR is complete response (CR) or partial response (PR)
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| ALX Center 9 | La Jolla | California | Recruiting |
| ALX Center 11 | Santa Monica | California | Recruiting |
| ALX Center 7 | Tampa | Florida | Recruiting |
| ALX Center 8 | Farmington Hills | Michigan | Recruiting |
| ALX Center 3 | Grand Rapids | Michigan | Recruiting |
| ALX Center 12 | Morristown | New Jersey | Recruiting |
| ALX Center 10 | Columbus | Ohio | Recruiting |
| ALX Center 6 | Portland | Oregon | Recruiting |
| ALX Center 5 | Houston | Texas | Recruiting |
| ALX Center 4 | West Valley City | Utah | Recruiting |
| ALX Center 2 | Fairfax | Virginia | Recruiting |
| ALX Center 1 | Spokane | Washington | Withdrawn |
More ALX Oncology Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07085091 on ClinicalTrials.gov ↗ ← All trials in the USA