A Phase I/II, Open-label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ 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.P03 monotherapy in adult patients with selected squamous solid tumors.
Description
This Study has a Phase I ALE.P03 monotherapy dose escalation and recommended dose for expansion (RDE) study and a Phase II study of ALE.P03 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 histologically and cytologically metastatic confirmed advanced or metastatic colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, and cervical squamous cell carcinoma. * Have documented radiological disease progression at study entry. * Have provided tissue for CLDN1 (Claudin-1) analysis in a central laboratory. Phase I Dose Escalation: \- Received and being refractory/intolerant to available systemic standard of care (SOC) regimens (based on local institutional guidelines) for advanced disease. Phase I RD…
Interventions
- DrugALE.P03
ALE.P03, will be administered by IV infusion according to the assigned arms.
- DrugALE.P03
ALE.P03, will be administered by IV infusion according to the assigned arms.
- DrugALE.P03
ALE.P03, will be administered by IV infusion according to the assigned arms.
Locations (28)
- Mayo Clinic Comprehensive Cancer CenterPhoenix, Arizona
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- Yale Comprehensive Cancer CenterNew Haven, Connecticut
- Norton Cancer Institute - Norton Healthcare PavilionLouisville, Kentucky
- John Theurer Cancer CenterHackensack, New Jersey
- MD Anderson Cancer CenterHouston, Texas