Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

This research study is called a 'first-in-human' trial, which means it's one of the first times this new treatment, DF1001, is being given to people. It's for adults with cancers that have grown or spread. The study is split into two main parts. First, it will carefully increase the dose of DF1001 to find a safe amount and understand any side effects. Researchers will also look at how the body handles the treatment and if it shows any signs of working against the cancer. Later, the study will expand to see how well DF1001 works in specific types of cancer, often in combination with other existing cancer medicines like OPDIVO or Abraxane.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Dragonfly Therapeutics Inc.

Enrolment target

174

Start

08 Nov 2024

Locally Advanced or Metastatic Solid Tumors and Expansion in Selected Indications

What is this study about?

This study is looking into a new treatment called DF1001 for people who have advanced cancers that have either grown locally or spread to other parts of the body. This is a very early-stage study, meaning it's one of the first times this new drug is being tested in humans. The main goals are to check if the new treatment is safe, what side effects it might cause, and how the body handles it.

The study has a few stages. Initially, a small group of patients will receive gradually increasing doses of DF1001. This helps the doctors find the highest dose that is safe and tolerable. They will carefully monitor for any unexpected or serious side effects during this time. Once a safe dose is identified, the study will move on to see if DF1001 can help to reduce the size of tumours or slow down their growth. This might involve using DF1001 on its own or in combination with other established cancer medicines like OPDIVO, Abraxane, or Sacituzumab Govitecan.

The information gathered from this study is really important. It helps scientists understand if DF1001 has the potential to become a new treatment option for cancer in the future. By studying how the drug works in the body and its effects on tumours, researchers hope to develop more effective ways to fight cancer.

Key takeaways

This is an early-stage study for a new cancer drug called DF1001.
It's for adults with advanced or spreading solid tumours.
The main aims are to check safety, side effects, and early signs of effectiveness.
You might receive DF1001 alone or with other established cancer drugs.
Taking part involves regular clinic visits, tests, and close monitoring.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. The study is open to both men and women.

You would need to have certain types of cancer that are considered locally advanced (meaning they've grown a fair bit in one area) or metastatic (meaning they've spread to other parts of your body).

There might be other health conditions or treatments that could stop you from taking part. The study doctors will carefully check your medical history to see if this study is right and safe for you.

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.

Are you 18 years old or older?
Do you have a diagnosis of locally advanced or metastatic (spreading) solid cancer?
Are you able to attend regular hospital appointments?
Are you able to understand and sign a consent form?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the new treatment, DF1001, along with possibly other cancer medications, through an infusion (like a drip). The study will involve regular visits to the clinic where you'll have various tests. These might include blood tests, physical examinations, and scans to see how your body is reacting to the treatment and if your cancer is changing.

Doses of the new drug will be carefully increased in the early stages, and you will be closely monitored for any side effects. The study will look at how long the treatment stays in your body and how your body processes it. You'll also be monitored for how well the treatment is working against your cancer. The exact number of visits and the total length of your participation will depend on how you respond to the treatment, but it will involve ongoing check-ups for a period of time.

Potential risks and benefits

Taking part in an early-stage study like this means that all the potential benefits and risks of the new treatment are not yet fully known. A potential benefit could be that the new drug might help to shrink your tumour or slow its growth, especially if other treatments haven't worked for you. However, there's no guarantee the treatment will work for everyone, and it might not help you at all. Like all medicines, DF1001 will have side effects, and some could be serious or unexpected. The study doctors will explain all known and potential risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Denmark
—
Unverified
Netherlands
—
Unverified
Belgium
—
Unverified
France

Common questions

What does 'first-in-human' mean?

It means this is one of the very first times this new treatment, DF1001, is being given to people. It's an early step in testing a new medicine.

What kind of cancers is this study for?

This study is for adults with cancers that are locally advanced (have grown a lot in one area) or have spread to other parts of the body.

What are 'side effects'?

Side effects are unwanted reactions or problems that can happen from taking a medicine. The study will carefully watch for any side effects from DF1001.

Will I get DF1001 on its own, or with other treatments?

You might get DF1001 on its own, or it might be given together with other known cancer treatments like OPDIVO or Abraxane, depending on the stage of the study.

What does a 'successful' outcome look like for this study?

A successful outcome usually means finding a safe dose, seeing that the treatment is well-tolerated, and hopefully showing signs that it can shrink tumours or stop them from growing.