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

A Study of NB003 in Patients With Advanced Malignancies

This research study is looking at a new medicine called NB003. We are inviting adults with certain advanced cancers to take part, including a type of stomach or bowel cancer (called Gastrointestinal stromal tumour), melanoma (a type of skin cancer), and other 'solid' tumours. This is one of the very first times this medicine will be given to people. The main goals are to find out if NB003 is safe, what dose works best, and if it has any effect on these cancers. It's an important step in developing new treatments, and participants will be closely monitored by a medical team. Anyone interested should discuss it with their doctor.

At a glance

Status

Ongoing, recruiting

Phase

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

Sponsor

Ningbo Newbay Technology Development Co. Ltd.

Enrolment target

Start

26 Jun 2023

Gastrointestinal stromal tumor Solid tumors Melanoma

What is this study about?

This study is for a new experimental medicine called NB003. It's being tested in adults who have been diagnosed with certain types of advanced cancer. These include a specific type of stomach or bowel cancer called Gastrointestinal stromal tumour (GIST), a type of skin cancer known as melanoma, and other cancers that form a solid lump (often referred to as 'solid tumours').

This is an early-stage study, meaning it's one of the first times NB003 will be given to humans. Researchers need to carefully check if the medicine is safe and what dose can be given without causing too many side effects. They will also be looking to see if NB003 has any hopeful effects on the cancer. Learning about new medicines like NB003 is vital for finding better ways to treat cancer in the future.

Taking part in a study like this means you would be trying an unproven treatment under close medical supervision. The information gathered will help doctors understand more about NB003 and decide if it should be tested in larger studies. Studies like this are how new treatments eventually become available to more people.

Key takeaways

This study is testing a new medicine called NB003 for advanced cancers.
It's an early-stage trial (first time in humans) focusing on safety and initial effects.
Open to adults aged 18 and over, both men and women.
Specific cancers include Gastrointestinal stromal tumour (GIST), melanoma, and other solid tumours.
You would receive close medical care and monitoring if you join.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. There is no upper age limit, meaning older adults are also welcome to take part if they meet the other requirements. Both men and women can participate in this research.

Beyond age and sex, the study is specifically for people with certain advanced cancers, including Gastrointestinal stromal tumour (GIST), melanoma, or other types of solid tumours. The medical team will check your overall health and specific cancer details to make sure this study is the right 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?
Have you been diagnosed with an advanced Gastrointestinal stromal tumour, melanoma, or another solid tumour?
Are you able to attend regular hospital/clinic appointments?
Are you happy to discuss this with your specialist doctor?

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, NB003, as directed by the study doctors. You would have regular appointments at the hospital or clinic. These visits would involve various assessments, which might include blood tests, physical examinations, and scans to monitor your health and how the medicine is affecting your cancer. Researchers will explain exactly how often you'd need to visit and for how long the study is expected to last for you.

Potential risks and benefits

Participating in a clinical trial has potential benefits and risks. You might benefit from receiving a new medicine before it's widely available, and you'd be contributing to medical research that could help others in the future. However, there's no guarantee the medicine will help your specific condition, and it might have side effects that are not yet fully known. You have the right to withdraw from 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 NB003?

NB003 is a new, experimental medicine being tested for certain advanced cancers. It's not yet approved for general use.

What does 'advanced' cancer mean in this study?

It means the cancer has progressed or spread, and standard treatments might not be working as well as hoped.

Will I know if I'm getting the actual medicine or a dummy pill?

In this early-stage study, all participants will receive the NB003 medicine, not a placebo (dummy pill), so the researchers can understand its effects.

How long will I be in the study?

The exact length of your participation would be discussed with you, but you would have regular follow-up appointments for a period after starting the medicine.

What if I feel unwell during the study?

You would be closely monitored by the study team, and you should tell them immediately if you experience any new or worsening symptoms.