Table of Contents
- Trial overview
- Who the trial is for
- What the study is testing
- Study phase and design
- Endpoints and measures
- What the study seeks to learn
Trial overview
The clinical trial with NCT ID 2024-515459-39-00 is an interventional study of ALE.P02 in adult patients with selected CLDN1+ solid tumors.[1] The study title says it is a study of ALE.P02 as monotherapy, which means ALE.P02 is given alone rather than with another treatment.[1] The trial is authorised and plans to enroll 170 participants.[1]
Who the trial is for
This study is for adults with selected CLDN1+ solid tumors.[1] The condition listed in the trial data is advanced or metastatic squamous solid tumors, which means the cancer is either advanced or has spread to other parts of the body.[1] The trial data do not give more detailed inclusion or exclusion rules in the source provided.[1]
What the study is testing
The study is designed to evaluate the safety and tolerability of ALE.P02, meaning how well people can receive the treatment and what side effects or problems may appear.[1] It also aims to assess anti-tumor activity, which means whether the treatment shows signs of helping the cancer shrink or respond.[1] The brief summary also says the trial is meant to establish the recommended phase 2 dose (RP2D), the dose chosen for later research after early safety results are reviewed.[1]
Study phase and design
The trial is Phase 1/2, so it combines early safety and dose-finding work with a later look at whether the treatment may work against the cancer.[1] The study is interventional, which means researchers assign the treatment and then observe the results.[1] The intervention listed is ALE.P02 given by intravenous infusion, meaning it is delivered through a vein.[1]
Endpoints and measures
The primary outcomes include dose-limiting toxicities (DLTs), which are side effects serious enough to limit treatment, and the incidence and severity of adverse events and serious adverse events.[1] The study also tracks clinically significant changes in laboratory values, vital signs, and electrocardiograms, which are heart tracing tests.[1] Tolerability is measured by dose interruptions and dose intensity, which help show how much treatment patients can receive as planned.[1]
For early efficacy, the trial uses RECIST 1.1, a standard method for measuring tumor response.[1] The study looks at overall response rate (ORR), defined in the source as complete response plus partial response, and duration of response (DoR), which is how long a response lasts.[1] The trial also plans CLDN1 and indication subgroup analysis, which means the results will be reviewed in smaller groups based on tumor marker status and cancer type.[1]
What the study seeks to learn
In the Phase I dose escalation part, the study aims to evaluate safety and tolerability and help choose the RP2D.[1] In the Phase II part, the study aims to assess anti-tumor activity in the target population.[1] Taken together, the trial is focused on whether ALE.P02 can be studied safely and whether it shows early signs of benefit in adults with selected CLDN1+ solid tumors.[1]
