RecruitingPHASE1INTERVENTIONAL

A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers

This is a new study, called a Phase 1 trial, looking into a drug named NXP900 for people living with advanced cancers such as non-small cell lung cancer, kidney cancer, or mesothelioma. The main aim is to find out if NXP900 is safe and what the best dose is. Doctors will also start to see if it has any effect on the cancer. Participants will have cancers that have grown or spread, and where standard treatments haven't worked or aren't suitable. This is one of the very first times this drug will be given to people, and it’s a crucial step in developing new cancer treatments.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Nuvectis Pharma, Inc.

Enrolment target

140

Start

26 Oct 2023

Estimated completion

01 Jul 2027

Advanced Solid Tumor NSCLC (Non-small Cell Lung Cancer)Renal Cancer Mesothelioma Non-Small Cell Squamous Lung Cancer Non-small Cell Lung Adenocarcinoma

What is this study about?

This clinical trial is an early-stage study, known as a Phase 1 trial, for a new drug called NXP900. It's designed for people who have advanced cancers that include specific types like non-small cell lung cancer (including squamous and adenocarcinoma types), kidney cancer (renal cancer), and mesothelioma, as well as other advanced solid tumours. When we say 'advanced,' it means the cancer has grown or spread, and current treatments haven't been successful or aren't suitable.

The main purpose of this study is to carefully look at the new drug, NXP900, to see how safe it is and to figure out the best dose to give. Because it's an early-stage trial, it's one of the first times this drug will be given to people. The study is divided into two parts: Part A to find the right dose, and Part B to expand the number of people taking that dose, especially those with cancers that have particular genetic changes that NXP900 might target.

Finding new treatments for cancer is incredibly important, and studies like this are the first step. By taking part, people are helping doctors understand if NXP900 could be a helpful option in the future for others with similar cancers. It's a way to explore new possibilities when other treatments have run out. Remember, this is a research study, and the drug is not yet approved as a standard treatment.

Key takeaways

This is an early-stage (Phase 1) clinical trial for a new cancer drug, NXP900.
It's for people with advanced, solid cancers like lung or kidney cancer.
The main goals are to check the drug's safety and find the best dose.
Participants receive the new drug NXP900, not a placebo.
Your cancer must be 'measurable' for you to be considered.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, people generally need to be 18 years or older and have certain types of advanced cancer that haven't responded to other treatments or for which further standard treatments are not suitable. Your cancer also needs to be 'measurable,' meaning doctors can see and track it with scans.

There are also some reasons why someone might not be able to join. For example, if you've had certain cancer treatments like chemotherapy or radiotherapy very recently (usually within 28 days), or if you have severe side effects from previous treatments that haven't cleared up. If you have active brain tumours that are getting worse, you might not be suitable either.

Quick self-check

Are you 18 years old or older?
Do you have an advanced solid cancer where standard treatments haven't worked or aren't suitable?
Can your cancer be measured on scans?
Have you recovered from any major surgery?
Are you able to manage standard check-ups and visits without too much difficulty?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll first have a lot of checks to make sure the study is right for you. This includes blood tests, scans, and physical exams. If you qualify, you'll start taking the study drug, NXP900. This is a "first-in-human" study, which means it's one of the first times this drug is being given to people. The study is "open-label," so you and your study team will know you are receiving NXP900.

In the first part of the study (Part A), a small group of people will start on a very low dose of NXP900. If this is safe, the next group will receive a slightly higher dose, and so on, until the best dose is found. In the second part (Part B), more people will receive this chosen dose. Throughout the study, you'll have regular hospital visits for blood tests, check-ups, and scans to see how you're doing and how the drug is affecting your body and your cancer. The exact number of visits and the total length of your participation will depend on how you respond to the drug, but the study team will explain everything in detail.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. The potential benefit is that NXP900 might help control your cancer, or at least slow its growth, especially if other treatments haven't worked. However, because this is an early-stage drug, we don't know for sure how effective it will be or what side effects it might cause. You might experience side effects from the drug, which the study team will monitor closely. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

Mayo Clinic
Phoenix, United States· Recruiting
Sarah Cannon Research Institute at HealthONE
Denver, United States· Recruiting
Mayo Clinic
Jacksonville, United States· Recruiting
University of Chicago
Chicago, United States· Recruiting
Mayo Clinic Rochester
Rochester, United States· Recruiting
Oregon Health and Science University
Portland, United States· Recruiting
The University of Texas MD Anderson Cancer Center
Houston, United States· Recruiting
NEXT Oncology Houston
Houston, United States· Recruiting
NEXT Oncology Dallas
Irving, United States· Recruiting
NEXT Oncology Virginia
Fairfax, United States· Recruiting
Western General Hospital - NHS Lothian
Edinburgh, United Kingdom· Completed
The Royal Marsden NHS Foundation and Trust
London, United Kingdom· Completed

Common questions

What is a Phase 1 study?

A Phase 1 study is the first step in testing a new drug in people. It mainly checks if the drug is safe and helps doctors find the right dose.

What type of cancer is this study for?

This study is for people with advanced solid cancers, including types of lung cancer (non-small cell), kidney cancer, and mesothelioma.

Will I get the new drug, NXP900?

Yes, in this study, everyone who participates will receive the new drug NXP900. There is no placebo group.

How long will I be in the study?

The length of time you'll be in the study can vary. It depends on how you respond to the treatment and what the study doctors think is best for you.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason. Your decision will not affect your future medical care.

How to find out more

Erin Belshaw

ebelshaw@nuvectis.com (201) 627-8129 Official trial record

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