In short
Clinical trials are investigating ALE.P03 in adults with selected advanced or metastatic CLDN1+ solid tumors. These studies are looking at safety, tolerability, dose finding, and early signs of anti-tumor activity. The trial includes Phase 1 and Phase 2 parts.
Key points
- ALE.P03 is being studied in adults with selected advanced or metastatic CLDN1+ solid tumors. The trial has a Phase 1 part and a Phase 2 part. Phase 1 focuses on safety, tolerability, dose escalation, and finding the recommended Phase 2 dose. Phase 2 focuses on anti-tumor activity, using measures such as overall response rate and duration of response. The study also looks at dose-limiting toxicities, lab values, vital signs, ECGs, and treatment interruptions. The trial is authorised and plans to enroll 180 participants.
Trial overview
This clinical trial is studying ALE.P03 in adult patients with selected advanced or metastatic CLDN1+ solid tumors. It is an interventional study, which means participants receive the study treatment so researchers can evaluate its effects.
The trial is designed as a Phase 1/2 study. The source data show that Phase 1 is for dose escalation and safety, while Phase 2 is for anti-tumor activity.
Who can participate
The study is for adult patients with selected advanced or metastatic solid tumors that are CLDN1+. In simple terms, the cancer must be at an advanced stage or have spread, and it must show the CLDN1 marker.
The trial title says the study is for selected tumor types, so not every solid tumor is included. The data also note that trial results may be analyzed by CLDN1 expression and by tumor type subgroup, which means the researchers may compare results across different cancer groups.
Study phases and goals
Phase 1 is the first part of the study and focuses on safety and tolerability. It includes dose escalation, which means the dose is increased step by step to learn what can be given safely.
Phase 1 also aims to establish the recommended Phase 2 dose, sometimes shortened to RP2D. This is the dose chosen for later testing after early safety and dose-finding results.
Phase 2 focuses on anti-tumor activity, meaning whether ALE.P03 shows signs of helping against the cancer. The brief summary says Phase 2 is meant to assess the anti-tumor activity of ALE.P03.
What is being measured
In Phase 1, the study measures dose-limiting toxicities, which are side effects serious enough to limit treatment. It also measures the number and severity of adverse events and serious adverse events.
The trial checks for clinically significant changes in laboratory values, vital signs, and ECGs. Laboratory values are results from blood or other tests, vital signs are basic health measurements such as blood pressure and pulse, and ECGs are heart tracing tests.
Researchers also look at tolerability, including dose interruptions and dose intensity. Dose interruptions mean treatment is paused, and dose intensity reflects how much treatment is actually given over time.
For early efficacy, the study uses RECIST 1.1, a standard method for measuring tumor response. The endpoints include overall response rate, or ORR, which combines complete response and partial response, and duration of response, or DoR, which shows how long a response lasts.
In Phase 2, the main efficacy endpoints are ORR and DoR by RECIST 1.1. The data also say that subgroup analyses may be done by CLDN1 expression and tumor type.
Trial status and size
The study status is Authorised. The planned enrollment is 180 participants.
The source data identify one trial record: NCT 2025-521441-24-00. This record describes the study of ALE.P03 in adults with selected advanced or metastatic CLDN1+ solid tumors.