A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
Sponsored by Alentis Therapeutics AG
About this study
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.
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.
Where this study is enrolling (3)
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Mayo Clinic Comprehensive Cancer Center
Phoenix, Arizona
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- Call 773-702-1234
The University of Chicago Medical Center - Oncology
Chicago, Illinois
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- Call 877-632-6789
MD Anderson Cancer Center
Houston, Texas
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Who can participate
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 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.
Exclusion criteria
- ✕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.
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Trial data sourced from ClinicalTrials.gov.