A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
Sponsor: Alentis Therapeutics AG
ClinicalTrials ID:NCT07169734
This study evaluates ALE.P03's safety, tolerability, and efficacy in advanced CLDN1+ cancers. It includes Phase I dose escalation and Phase II at RP2D. Eligible patients have progressed on SOC regimens and must have measurable disease, good performance status, and adequate organ function. ALE.P03 is administered via IV infusion.
Patient Parameters
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Program Overview
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 Criteria
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Next Oncology-Oncology | 78229 | San Antonio | Texas |
| NEXT Oncology Virginia | 22031 | Fairfax | Virginia |
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