Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

A Phase 1/2, First-In-Human, Multi-Part, Open Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a Monotherapy and in Combination with Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

This research trial is investigating a new medication called DF6002 for people with advanced solid tumors, which are cancers that have grown or spread. It's being tested by itself and also combined with another cancer drug called Nivolumab (OPDIVO). This is a 'first-in-human' study, meaning it's among the first times DF6002 is given to people. The main goals are to check if the new drug is safe, what side effects it might cause, and how the body handles it. Researchers also want to see if it helps shrink tumors or stop them from growing. The study is divided into two main parts: an early phase to find the right dose and check safety, and a later phase to further assess its effects on cancer.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Dragonfly Therapeutics Inc.

Enrolment target

Start

25 Mar 2024

Advanced Solid Tumors

What is this study about?

Imagine your body as a complex machine. When cancer grows, it can disrupt how that machine works. Scientists are always looking for new ways to fix these problems. This study is like a very careful test run for a brand-new 'tool' called DF6002, designed to help fight cancer. We're also checking to see if this new tool works even better when combined with an existing, approved cancer treatment called Nivolumab.

The main aim of this study is to make sure this new treatment is safe for people. Since it's a 'first-in-human' study, meaning it's one of the first times this drug is being given to people, careful monitoring is key. Researchers will start with small doses and slowly increase them, watching closely for any side effects. They'll also be trying to understand how your body uses and gets rid of the drug, which is important for finding the most effective and safest dose.

After ensuring safety and finding a good dose, the study will then look more closely at how the treatment affects the cancer itself. This means they will be checking to see if tumors shrink, stop growing, or if the treatment helps patients feel better. This research is vital because it helps us learn if DF6002 could be a promising new option for people living with advanced solid tumors in the future.

Key takeaways

This study tests a new drug (DF6002) for advanced solid tumors.
It aims to find safe doses and see if it helps shrink or control cancer.
The drug may be given alone or with an existing treatment (Nivolumab).
It's an early-stage study, meaning careful safety checks are a priority.
Regular hospital visits, tests, and scans will monitor your health and tumor response.

Who may be eligible?

To join this study, you need to be an adult, 18 years or older, with a diagnosis of advanced solid tumors. These are cancers that have grown or spread and are not responding well to standard treatments, or where standard treatments aren't available.

There will also be other specific health requirements that the study doctors will discuss with you. These checks are important to make sure the treatment is as safe as possible for you and that the study results are clear. For example, your general health, organ function, and any other medical conditions you have will be reviewed.

Both men and women can take part in this study. The medical team will review all your health information carefully to see if this particular study is a good fit 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 advanced solid tumors?
Are you currently in general good health, despite your cancer?
Are you willing to attend regular hospital visits for treatment and check-ups?
Are you able to understand and provide informed consent?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the study drug (DF6002, and potentially Nivolumab) either into a vein or as a tablet, depending on the study part. You'll have regular hospital visits for check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor for any side effects. These scans will help the doctors see if your tumors are shrinking or staying the same.

Throughout the study, you'll have doctors and nurses closely monitoring your health, asking about any symptoms you experience, and performing physical exams. The number of visits and tests will be more frequent at the beginning of the study and may become less so over time. The total duration of your participation will depend on how you respond to the treatment and the study plan, but you'll be carefully followed up as long as needed for your safety and to collect all necessary information.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as receiving a new and experimental treatment that might help when other options haven't worked or aren't available. However, there's no guarantee that the treatment will be effective for you. As with any new medicine, there are potential risks, including side effects that can range from mild to severe. The study team will carefully monitor you for any problems. You will be given full information about all known and possible risks before you agree to take part. Remember, joining is always your choice, and you are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (2)

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

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Unverified
France
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Unverified
Spain

Common questions

What is a 'solid tumor'?

A solid tumor is a lump or mass of tissue that doesn't contain cysts or liquid areas. Most cancers are solid tumors, like breast, lung, or bowel cancer.

What does 'first-in-human' mean?

It means this is one of the very first times the new drug, DF6002, is being tested in people. This helps researchers understand its safety and effects in humans.

What is Nivolumab (OPDIVO)?

Nivolumab is an approved cancer treatment, often called immunotherapy. It works by helping your body's immune system fight cancer cells.

Will I know if the drug is working?

The study team will regularly perform scans and tests to check for changes in your tumors. They will discuss these results with you.

What if I feel unwell during the study?

The study team will give you clear instructions on who to contact immediately if you experience any side effects or feel unwell. You will be closely monitored throughout.