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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 RDE and Phase II:
Received 1-2 available systemic SOC regimens (based on local institutional guidelines) for advanced disease and being refractory or intolerant to treatment.
Patients with actionable oncogenic drivers: received feasible targeted therapy.
Applicable for Phase I Dose Escalation, Phase I RDE and Phase II:
Measurable disease per RECIST 1.1, as determined by the site.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Groups Performance Status.
Demonstrate adequate bone marrow and organ function as per the protocol.
You may not be if
SqNSCLC and CSCC: diagnosed with a tumor of predominantly non-squamous histology result or adenocarcinoma.
Has received antineoplastic therapies prior to study intervention within specified time frame.
Has rapidly progressing disease.
Has known active central nervous system metastases and/or carcinomatous meningitis.
Has a history of (non-infectious) interstitial lung disease/pneumonitis that required steroids or current symptomatic or clinically significant pneumonitis requiring steroids and/or immunosuppressive therapies.
Has clinically significant gastrointestinal bleeding.
Has an active infection requiring systemic treatment.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study.
