Table of contents
- Trial overview
- Who can participate
- Study phases and goals
- What is being measured
- Trial status and size
Trial overview
This clinical trial is studying ALE.P03 in adult patients with selected advanced or metastatic CLDN1+ solid tumors.[1] It is an interventional study, which means participants receive the study treatment so researchers can evaluate its effects.[1]
The trial is designed as a Phase 1/2 study.[1] The source data show that Phase 1 is for dose escalation and safety, while Phase 2 is for anti-tumor activity.[1]
Who can participate
The study is for adult patients with selected advanced or metastatic solid tumors that are CLDN1+.[1] In simple terms, the cancer must be at an advanced stage or have spread, and it must show the CLDN1 marker.[1]
The trial title says the study is for selected tumor types, so not every solid tumor is included.[1] 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.[1]
Study phases and goals
Phase 1 is the first part of the study and focuses on safety and tolerability.[1] It includes dose escalation, which means the dose is increased step by step to learn what can be given safely.[1]
Phase 1 also aims to establish the recommended Phase 2 dose, sometimes shortened to RP2D.[1] This is the dose chosen for later testing after early safety and dose-finding results.[1]
Phase 2 focuses on anti-tumor activity, meaning whether ALE.P03 shows signs of helping against the cancer.[1] The brief summary says Phase 2 is meant to assess the anti-tumor activity of ALE.P03.[1]
What is being measured
In Phase 1, the study measures dose-limiting toxicities, which are side effects serious enough to limit treatment.[1] It also measures the number and severity of adverse events and serious adverse events.[1]
The trial checks for clinically significant changes in laboratory values, vital signs, and ECGs.[1] 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.[1]
Researchers also look at tolerability, including dose interruptions and dose intensity.[1] Dose interruptions mean treatment is paused, and dose intensity reflects how much treatment is actually given over time.[1]
For early efficacy, the study uses RECIST 1.1, a standard method for measuring tumor response.[1] 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.[1]
In Phase 2, the main efficacy endpoints are ORR and DoR by RECIST 1.1.[1] The data also say that subgroup analyses may be done by CLDN1 expression and tumor type.[1]
Trial status and size
The study status is Authorised.[1] The planned enrollment is 180 participants.[1]
The source data identify one trial record: NCT 2025-521441-24-00.[1] This record describes the study of ALE.P03 in adults with selected advanced or metastatic CLDN1+ solid tumors.[1]
