Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Phase 1 Open-label, Multicenter, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of HPN217 in Patients with Relapsed/Refractory Multiple Myeloma

This research study is for people who have multiple myeloma, a type of blood cancer, that has either returned after previous treatments or isn't getting better with current medicines. The study is testing a new drug called HPN217. It's an early-stage study, meaning it's the first time this medicine is being given to humans. The main goals are to find out if HPN217 is safe to use, how well people can tolerate different doses, and how the body processes the medicine. By carefully studying these things, researchers hope to learn if HPN217 could be a helpful new treatment option in the future for people living with this challenging condition.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Harpoon Therapeutics Inc.

Enrolment target

Start

11 Sep 2024

Relapsed/Refractory Multiple Myeloma (RRMM)Recurrent Multiple Myeloma that does not respond to treatment

What is this study about?

This study is about a new potential medicine called HPN217 for people who have multiple myeloma. Multiple myeloma is a cancer that affects certain cells in your bone marrow. Sometimes, even after treatment, the cancer can come back (this is called 'relapsed') or it might not respond to the treatments given ('refractory'). When this happens, doctors need new ways to help patients.

This particular study is a very early step in testing HPN217. It's known as a 'Phase 1' study, which means it's the first time this medicine is being given to people. The main purpose at this stage is not to cure the cancer, but to carefully check a few important things: Is HPN217 safe to use? Are there any side effects, and how do people cope with them? What is the best amount (dose) of the medicine to give? And how does the body absorb, use, and get rid of the medicine?

By gathering this vital information, researchers can decide if HPN217 is promising enough to move on to bigger studies with more people in the future. The hope is that through studies like this, new and better treatments for multiple myeloma can be found, offering more options for patients when current treatments aren't enough.

Key takeaways

This study is for adults with multiple myeloma that has come back or isn't responding to other treatments.
It's testing a new medicine called HPN217 for the first time in people.
The main goals are to check the medicine's safety, side effects, and best dose.
Participation involves regular hospital visits for tests and monitoring.
You can stop participating at any time if you change your mind.

Who may be eligible?

This study is looking for adults aged 18 or older who have multiple myeloma. Your cancer must have returned after previous treatments or not responded to those treatments.

To be considered, you'll need to meet several health requirements. For example, your other body functions, like your kidneys and liver, need to be working well enough for you to safely receive the study medicine. The doctors will do tests to make sure you are in suitable health to take part.

There will also be other specific medical conditions or treatments that might mean you can't join the study, to ensure your safety. The study team will review your complete medical history and discuss these details with you thoroughly.

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 multiple myeloma that has returned or is not responding to treatment?
Are you generally well enough to start a new treatment?
Are you able to attend regular hospital visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, HPN217. Since it’s an early-stage study, the doctors would start with a very low dose of the medicine and slowly increase it in a step-by-step way for different groups of patients, watching carefully to see how your body reacts.

This study will involve regular visits to the hospital or clinic. During these visits, you’ll have blood tests, physical examinations, and other checks to see how you are doing and how the medicine is affecting you. The study team will monitor you closely for any side effects. The total duration of your participation could vary, as you would continue to receive the medicine as long as it is helping you and you are tolerating it well, with regular follow-up appointments.

Potential risks and benefits

Taking part in this study gives you access to a new medicine that isn't yet widely available, which might help if your current treatments aren't working. However, as with any new medicine, there are potential risks. You might experience side effects, some of which could be serious, and the medicine might not work for you. The study team will explain all known and potential risks in detail. It's important to remember that you can decide to stop participating in the study at any time, for any reason, without it affecting your usual 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
Spain
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Unverified
France

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects plasma cells, which are a kind of white blood cell found in your bone marrow.

What does 'relapsed/refractory' mean?

It means your multiple myeloma has either come back after treatment, or it hasn't responded to the treatments you've already had.

What is HPN217?

HPN217 is a new experimental medicine being tested for multiple myeloma. It's not yet approved as a standard treatment.

Why is this a 'Phase 1' study?

Phase 1 means it's the very first time this medicine is being given to people. The main goal is to check its safety and find the right dose.

Will I definitely get better if I join this study?

There's no guarantee that participating in the study will make you better. The main goal at this stage is to learn about the medicine's safety and how it works.