Table of Contents
- Trial overview
- Who could participate
- Study design and treatment groups
- What the trials measured
- Trial status and size
- What the main terms mean for patients
Trial overview
The available study investigated Ale.c04 in people with recurrent or metastatic head and neck squamous cell carcinoma, which means the cancer had come back or spread to other parts of the body.[1]
This was an interventional trial, meaning the research team gave a study treatment and then watched what happened.[1]
The study was designed as a phase 1/2 trial, so it combined early safety testing with a later look at how well the treatment worked.[1]
Who could participate
The trial focused on patients with recurrent or metastatic head and neck squamous cell carcinoma.[1]
That means the study was not for all cancer types, but for this specific cancer group only.[1]
The title also shows that the study included people in the first-in-human setting, which means this was an early study of Ale.c04 in patients.[1]
Study design and treatment groups
The brief summary says the trial tested Ale.c04 as monotherapy, which means as a single treatment, and also in combination with pembrolizumab.[1]
Phase 1 used dose escalation, which means the team increased the dose step by step to learn which dose could be given safely.[1]
The study also aimed to establish the recommended phase 2 dose for Ale.c04 with pembrolizumab, which is the dose chosen for later testing after early results.[1]
In phase 2, the trial compared the anti-tumor effect of Ale.c04 plus pembrolizumab with pembrolizumab alone.[1]
What the trials measured
The main safety endpoint was the incidence of dose-limiting toxicities, or DLTs, which are side effects serious enough to limit treatment at a given dose.[1]
The study also measured the incidence and severity of adverse events and serious adverse events, which are unwanted medical problems during the trial.[1]
Other safety checks included changes in laboratory values, vital signs, and ECGs, which are tests that record the heart’s electrical activity.[1]
Tolerability was also assessed by dose interruptions and dose intensity, meaning whether treatment had to be paused and how much of the planned treatment a patient actually received.[1]
For effectiveness, the trial compared progression-free survival by RECIST 1.1 using blinded independent central review, which is a standard way to measure how long the cancer stays from getting worse.[1]
The study also planned subgroup analysis for CLDN1 and PD-L1, which means results were checked in smaller patient groups based on these markers.[1]
Trial status and size
The trial was marked as completed.[1]
The enrollment was 160, meaning 160 participants were planned or included in the study record.[1]
What the main terms mean for patients
Safety means checking whether the treatment causes medical problems.[1]
Tolerability means how well patients can stay on the treatment without needing major changes.[1]
Anti-tumor efficacy means how well the treatment may help fight the cancer.[1]
Subgroup analysis means looking at results in smaller groups of patients to see if the treatment works differently in those groups.[1]
