Table of Contents

• Trial overview
• Study design and treatment groups
• Who can participate
• What researchers measure
• Trial status and size

Trial overview

The available study is a Phase 1/2 clinical trial of Mdna11 in people with advanced solid tumors.^[1] The study is designed to look at Mdna11 given alone and in combination with pembrolizumab, which is described in the trial as a checkpoint inhibitor.^[1]

The main goals are to evaluate safety, tolerability, pharmacokinetic properties, pharmacodynamic effects, and early anti-tumor activity.^[1] In simple terms, the researchers want to see how the treatment is handled by the body, what it does in the body, and whether it shows early signs of helping against cancer.^[1]

Study design and treatment groups

This is an interventional study, which means the research team gives the study treatment and watches what happens.^[1] The trial includes both dose escalation/evaluation and dose expansion parts.^[1]

In the dose escalation and evaluation part, the team studies Mdna11 alone and together with pembrolizumab to find the recommended dose for expansion, called the RDE, and/or the maximum tolerable dose, called the MTD.^[1] The trial summary says these decisions will be based on safety, tolerability, immunological response, pharmacokinetic and pharmacodynamic results, and early anti-tumor activity data.^[1]

In the dose expansion part, the study continues to assess Mdna11 alone and in combination with pembrolizumab, with a stronger focus on safety and anti-tumor activity.^[1]

Who can participate

The target population is patients with selected advanced solid tumors.^[1] The trial data provided here do not list every inclusion or exclusion rule, so the full participation rules are not shown in this source.^[1]

Because the study is focused on advanced cancer, it is aimed at people whose disease is already at a later stage rather than people with early-stage disease.^[1]

What researchers measure

The main primary outcomes in the dose escalation and evaluation part are safety and tolerability, including the number and severity of adverse events, serious adverse events, abnormal laboratory results, changes in vital signs, and ECG findings.^[1] The study also looks for dose-limiting toxicities, which are side effects serious enough to affect how much treatment can be given.^[1]

For the expansion part, the study again checks safety and also measures anti-tumor activity using iRECIST and RECIST 1.1.^[1] These are standard methods for reading scans and judging whether tumors shrink, stay stable, or grow.^[1]

The trial specifically lists several response measures: overall response rate (how many people have a meaningful tumor shrinkage), clinical benefit rate, disease control rate (how many people have shrinkage or stable disease), duration of response, time to response, progression-free survival, best overall response, and overall survival.^[1]

Trial status and size

The trial status is listed as Authorised.^[1] The planned enrollment is 191 participants.^[1]

That number shows the study is fairly large for an early trial, which may help researchers better understand both safety and early signs of benefit across the study groups.^[1]