A Phase I/II, Open-Label, Multicenter Study of ALE.P02 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+Squamous Solid Tumors
Alentis Therapeutics AG
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P02 monotherapy in adult patients with selected squamous solid tumors.
Description
This Study has a Phase I ALE.P02 monotherapy dose escalation and recommended dose for expansion (RDE) study and a Phase II study of ALE.P02 as monotherapy at RP2D in adult patients with selected advanced or metastatic Claudin-1 positive (CLDN1+) cancers.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Have disease and treatment history as: Have histologically or cytologically confirmed advanced locally recurrent and inoperable or metastatic SqNSCLC, HNSCC (nasopharyngeal cancer included), ESCC or CSCC. * Phase I Dose Escalation: Have received at least one systemic standard of care regimen and being refractory or intolerant to the treatment. * Phase I RDE and Phase II: Have received no more than 2 lines of systemic standard of care regimen and being refractory or intolerant to the treatment. * Have provided tissue for CLDN1 analysis in a central laboratory. * Have a pe…
Interventions
- DrugALE.P02
ALE.P02, will be administered by IV infusion according to the assigned arms.
Locations (38)
- Mayo Foundation for Medical Education and Research - Mayo ClScottsdale, Arizona
- Providence Medical FoundationFullerton, California
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- Yale Comprehensive Cancer CenterNew Haven, Connecticut
- The University of Chicago Medical Center - OncologyChicago, Illinois
- Norton Cancer Institue DowntownLouisville, Kentucky