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

NCT07169734 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-03-19

No results posted yet for this study

Summary

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.

Conditions

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.

Sponsors & Collaborators

  • Alentis Therapeutics AG

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-26
Primary Completion
2029-04-05
Completion
2029-10-04
FDA Drug
Yes

Countries

  • United States
  • France
  • Hong Kong
  • Italy
  • Netherlands
  • Singapore
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07169734 on ClinicalTrials.gov