A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors

Alentis Therapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Urothelial Carcinoma; Intrahepatic Cholangiocarcinoma; Squamous Non-small-cell Lung Cancer; Cervical Squamous Cell Carcinoma; Colorectal Cancer

Treatments: Drug: ALE.P03

Study type: Interventional

Funder types: Industry

Identifiers

NCT07169734

ALE.P03.01

2025-521441-24-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

Phase I Dose Escalation- ALE.P03

Experimental group

Description:

Patients will receive ALE.P03 as monotherapy via intravenous infusion. The ALE.P03 will be given at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended dose for expansion (RDE) is determined in Phase I dose escalation part of the study.

Treatment:

Drug: ALE.P03

Drug: ALE.P03

Drug: ALE.P03

Phase I Dose Expansion- ALE.P03

Experimental group

Description:

Patients will receive ALE.P03 as monotherapy via intravenous infusion. The safe recommended doses of ALE.P03 will be given in Phase I dose expansion part of the study to identify recommended Phase II dose (RP2D) for Phase II.

Treatment:

Drug: ALE.P03

Drug: ALE.P03

Drug: ALE.P03

Phase II- ALE.P03

Experimental group

Description:

Patients will receive ALE.P03 as monotherapy via intravenous infusion at the RP2D, or according to the dosing schedule after the dose expansion phase.

Treatment:

Drug: ALE.P03

Drug: ALE.P03

Drug: ALE.P03