NCT07169734 · Alentis Therapeutics AG
A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
What this study is about
The purpose of this study is to evaluate the safety, tolerability, how the drug moves through the body, how the drug affects the body, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P03 treatment given alone in adult patients with selected squamous solid tumors.
View original scientific description
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.
Interventions
DRUG
ALE.P03
ALE.P03, will be administered by IV infusion according to the assigned arms.
DRUG
ALE.P03
ALE.P03, will be administered by IV infusion according to the assigned arms.
DRUG
ALE.P03
ALE.P03, will be administered by IV infusion according to the assigned arms.
Primary outcome measures
Number of Patients with Dose Limiting Toxicities (DLTs) (Phase I)
Time frame: Up to 28 days
DLTs as defined in the protocol will be assessed to evaluate safety and tolerability of ALE.P03 (Phase I Dose Escalation), and to establish RP2D for ALE.P03 (Phase I RDE).
Number of Patients with Adverse Events (Phase I)
Time frame: From Day 1 up to Safety follow-up (30 ± 5 days post last dose [Up to 4 years])
Adverse events will be assessed to evaluate safety and tolerability of ALE.P03 (Phase I Dose Escalation), and to establish RP2D for ALE.P03 (Phase I RDE).
Overall Response Rate (ORR) (Phase I)
Time frame: From ALE.P03 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 4 years)
The ORR is the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.) This is assessed to establish RP2D for ALE.P03 (Phase I RDE)
Duration of Response (DoR) (Phase I)
Time frame: From ALE.P03 treatment initiation until disease progression or study completion (Up to 4 years)
The DoR is defined for patients achieving a CR or PR as per Investigator review according to RECIST 1.1 to disease progression before new anti-cancer therapy or death of any cause, whichever occurs earlier. This is assessed to establish RP2D for ALE.P03 (Phase I RDE).
Overall Response Rate (ORR) (Phase II)
Time frame: From ALE.P03 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 4 years)
The ORR is assessed to assess anti-tumor activity of ALE.P03 (Phase II).
Duration of Response (DoR) (Phase II)
Time frame: From ALE.P03 treatment initiation until disease progression or study completion (Up to 4 years)
The DoR is defined for patients achieving a confirmed CR or PR as the time from the initial response of CR or PR to disease progression before new anti-cancer therapy or death of any cause, whichever occurs earlier. This is assessed to assess anti-tumor activity of ALE.P03 (Phase II).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Phoenix, Arizona
- Los Angeles, California
- New Haven, Connecticut
- Chicago, Illinois
- Louisville, Kentucky
- Hackensack, New Jersey
- Houston, Texas
- San Antonio, Texas
- Fairfax, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2026 · Source of record for eligibility and locations