RecruitingPHASE1, PHASE2INTERVENTIONAL

Study of DT-7012 as a Single Agent and in Combination With an Immune Checkpoint Inhibitor in Participants With Advanced Solid Tumors

This study is looking into a new treatment called DT-7012 for adults with advanced solid tumours where standard treatments haven't worked or are no longer an option. Researchers want to find out if DT-7012 is safe, what the best dose is, and how well it works, both when given alone and when combined with a type of cancer drug called an immune checkpoint inhibitor. This is an early-stage clinical trial (Phases 1 and 2), which means it's one of the first times this drug is being tested in humans. The study also aims to understand how the drug moves through the body and what effects it has.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Domain Therapeutics Australia Pty Ltd

Enrolment target

125

Start

25 Jun 2025

Estimated completion

01 Jan 2028

Advanced Solid Tumors

What is this study about?

This study is a clinical trial exploring a new drug called DT-7012. It's being tested in adults who have a type of cancer known as 'advanced solid tumours'. This means the cancer has spread or come back, and current treatments aren't working or there are no other options available. The study is divided into two main parts: Phase 1 and Phase 2. In Phase 1, the main goal is to check how safe DT-7012 is, find the dose that is best tolerated, and understand how it works in the body. This is done by giving the drug on its own first, and then in combination with another type of cancer treatment called an 'immune checkpoint inhibitor'.

After finding a safe and well-tolerated dose in Phase 1, the study moves to Phase 2. In this stage, the main focus is to see how effective DT-7012 is at treating specific types of cancer. Researchers will be looking to see if the drug can shrink tumours, stop their growth, or improve how patients feel. This part of the study will involve different groups of patients with specific types of advanced solid tumours.

Taking part in a study like this helps doctors learn more about new treatments. This particular research is trying to find new ways to fight advanced cancers, potentially offering new hope for patients who have limited treatment options. The study is carefully designed to put patient safety first while gathering important information about this new drug.

Key takeaways

This study tests a new drug (DT-7012) for advanced solid tumours.
It aims to find safe doses and see how well it works, alone and with another cancer drug.
It's an early-stage study (Phase 1/2) for people where standard treatments haven't worked.
You'll be closely monitored for safety and any side effects.
Participation is voluntary, and you can leave the study at any time.

Who may be eligible?

To join this study, you would need to have an advanced solid tumour that has been confirmed by laboratory tests. This means the cancer has come back, spread, or is too advanced for surgery or radiation to cure, and you've already tried at least one other treatment that wasn't successful. Your cancer also needs to be easily measured by scans, and there should be at least one tumour that can be biopsied if needed.

You would also need to be generally well and able to carry out most daily activities, as measured by a score called ECOG PS of 0 or 1. Your body's organs, like your kidneys and liver, must be working well. This is to ensure you can safely take the study medication.

There are also some reasons why you might not be able to join. For example, if you have ongoing side effects (grade 2 or higher, except for hair loss) from previous cancer treatments that haven't cleared up. You also couldn't join if you've had certain severe immune-related side effects from previous immunotherapy that led to you stopping that treatment, or if you've had major surgery or radiation therapy very recently. Also, if you've ever had a treatment like DT-7012 before in another research study, you wouldn't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my solid tumour advanced (spread or returned) and not curable by surgery/radiation?
Have I already tried at least one other cancer treatment that wasn't successful?
Am I generally well and able to do most daily activities?
Do my organs (like liver and kidneys) generally work well?
Have I had any major surgery or radiation very recently (in the last 4 weeks)?
Do I have any serious side effects from previous treatments that haven't gone away yet (not just hair loss)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study drug, DT-7012, either on its own or combined with an immune checkpoint inhibitor. The study is 'open-label', meaning both you and your study doctor will know which treatment you are receiving. Before starting, and regularly throughout the study, you would have various visits that involve physical exams, blood tests, and scans (like CT or MRI). These tests are important to check your health, see how the treatment is affecting you, and measure any changes in your cancer. The exact number of visits and tests will depend on which phase of the study you are in. You'll be closely monitored for any side effects. The total duration of your participation would depend on how you respond to the treatment and the phase of the study, but you would have regular follow-up appointments.

Potential risks and benefits

Participating in this study might offer a potential benefit of receiving a new treatment for your advanced cancer that is not yet widely available. However, there's no guarantee that the treatment will work for you. Like all medications, DT-7012 may have side effects, some of which could be serious or unexpected. The research team will carefully monitor you for any side effects and manage them as best they can. It's important to remember that joining a clinical trial is always voluntary, and you can withdraw from the study at any time and for any reason, without it affecting your usual medical care.

Locations (9)

Honor Health Research Institute
Verified postcode
Scottsdale, United States· Not yet recruiting
Macquarie University Clinical Trial Unit
Verified postcode
North Ryde, Australia· Recruiting
Cancer Research SA
Verified postcode
Adelaide, Australia· Recruiting
Peninsula & South Eastern Haematology & Oncology Group
Verified postcode
Frankston, Australia· Recruiting
Cabrini Health Limited
Verified postcode
Malvern, Australia· Recruiting
One Clinical Research Pty Ltd
Verified postcode
Nedlands, Australia· Recruiting
Institut Bergonié
Verified postcode
Bordeaux, France· Recruiting
Hôpitaux Universitaires de Strasbourg
Verified postcode
Strasbourg, France· Recruiting
Institut Gustave Roussy
Verified postcode
Villejuif, France· Recruiting

Common questions

What are 'advanced solid tumours'?

These are cancers that started in solid organs (like lungs, breast, bowel) and have either spread to other parts of the body or have come back after previous treatments, and cannot be cured by surgery or radiation.

What is an 'immune checkpoint inhibitor'?

It's a type of cancer treatment that helps your body's own immune system find and attack cancer cells more effectively.

What does 'Phase 1/2' study mean?

It's an early stage of clinical research. Phase 1 focuses on safety and finding the right dose, while Phase 2 looks at how well the treatment works for specific cancers.

Will I know if I'm getting the new drug?

Yes, this is an 'open-label' study, which means you and your doctors will know you are receiving DT-7012, either alone or with another drug.

Can I stop participating in the study if I want to?

Yes, absolutely. Your participation is voluntary, and you can decide to leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Clinical Development

clinicaltrials@domaintherapeutics.com 0033390406150 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.