RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

This research study, called NDI-219216, is looking at a new medicine for people with advanced solid cancers, including those with a specific type called MSI-H cancer. It's being conducted in two main parts, Phase 1 and Phase 2. The main aim is to understand if the new medicine is safe to use and what side effects it might have. Researchers also want to see how the medicine acts in the body and if it has any effect on the size of tumours. Participants will take the medicine daily and attend regular check-ups, helping doctors learn more about this potential new treatment.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Nimbus Wadjet, Inc.

Enrolment target

134

Start

31 Mar 2025

Estimated completion

01 Dec 2031

Advanced Solid Tumors Cancer MSI-H Cancer

What is this study about?

This clinical trial is designed to investigate a new medication, NDI-219216, for individuals who have advanced solid cancers. These are cancers that have spread or cannot be removed by surgery. The study also includes people with a specific type of cancer known as MSI-H cancer.

The main purpose of this study is to find out if NDI-219216 is safe for patients and what kinds of mild or serious effects it might have on the body. This is an important first step for any new medicine. Following that, the study will also explore whether NDI-219216 could potentially help by reducing the size of tumours in patients, as a possible future treatment option.

By taking part, you would be helping doctors and researchers understand more about NDI-219216. The information gathered from this study will help decide if this medicine should be tested in larger groups of patients in the future, with the hope of finding new ways to treat advanced solid cancers.

Key takeaways

This study is testing an experimental medicine (NDI-219216) for advanced solid cancers.
The main goals are to check if it's safe and if it helps with tumour size.
Participation involves taking daily medication and regular clinic visits.
It's an early-stage trial, exploring a potential new treatment option.
Your general health and specific cancer type will determine if you can join.

Who may be eligible?

To be able to join this study, you would generally need to have an advanced solid cancer that cannot be removed by surgery or has spread. This includes some cancers with a specific characteristic called MSI-H or dMMR. You would also need to have tried standard treatments that didn't work or for which there isn't a current standard treatment available. Your general health should be good enough to take part in the trial, and your body's main organs (like your heart, liver, and kidneys) need to be working well.

There are also some reasons why you might not be able to join. For example, if you have a serious heart condition or a rare genetic condition called WRN syndrome. Also, if you are pregnant, breastfeeding, or planning to become pregnant, you would not be able to participate. Your doctor can help you understand all the specific details of whether this study is right for you, based on your medical history.

Quick self-check

Do I have an advanced solid cancer that has spread or can't be surgically removed?
Have I tried standard treatments for my cancer, or are there no standard treatments available?
Is my general health good enough, and are my main organs working well?
Am I at least 18 years old?
Am I pregnant, breastfeeding, or planning to become pregnant during the study?

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

What does participation involve?

If you join this study, you will take the medicine NDI-219216 by mouth every day. You'll need to attend regular clinic visits for check-ups and tests. In the first month (called Cycle 1), you'll visit the clinic 6 times. In the second month (Cycle 2), you'll visit twice. After that, you'll have one clinic visit each month for as long as you are taking the study medicine.

Throughout the study, you'll be asked to keep a diary to record when you take your tablets and any symptoms you experience. Once you finish taking the study medicine, you'll have a final visit to the clinic. After that, there will be some follow-up checks, which can often be done over the phone. The total duration of your participation will depend on how you respond to the treatment.

Potential risks and benefits

Taking part in a study like this might offer the potential benefit of trying a new medicine that could help your condition, especially if other treatments haven't worked. However, it's important to remember that this is an early-stage study, so the benefits are not guaranteed. There might be side effects from the study medicine, and some could be serious or unexpected. You will be closely monitored for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (22)

USC Norris Comprehensive Cancer Center
Los Angeles, United States· Recruiting
University of Chicago Medicine
Chicago, United States· Recruiting
University of Louisville James Graham Brown Cancer Center
Louisville, United States· Recruiting
Cayuga Cancer Center
Ithaca, United States· Terminated
Levine Cancer Center
Charlotte, United States· Recruiting
Atrium Health Wake Forest Baptist Center
Winston-Salem, United States· Recruiting
Taylor Cancer Research Center
Maumee, United States· Recruiting
Brown University Health
Providence, United States· Recruiting
Prisma Health Cancer Institute - Multidisciplinary Center
Greenville, United States· Recruiting
University of Virginia Emily Couric Clinical Cancer Center
Charlottesville, United States· Recruiting
Virginia Cancer Specialists, P.C. - Fairfax
Fairfax, United States· Recruiting
Liverpool Hospital
Liverpool, Australia· Recruiting

+10 more sites — see the official record for the full list.

Common questions

What is an advanced solid tumour?

An advanced solid tumour is a cancer that started in an organ and has either spread to other parts of the body or cannot be removed through surgery.

What does MSI-H cancer mean?

MSI-H refers to a specific genetic change found in some cancer cells. Doctors test for this to help decide on the best treatments.

Is NDI-219216 a new type of chemotherapy?

The study aims to understand what kind of medicine NDI-219216 is and how it works. It's a new medicine being tested, not necessarily a traditional chemotherapy.

How long will I be on the study medicine?

The length of time you take the medicine will depend on how you respond and how well you tolerate it. Your doctor will discuss this with you.

Will I know if the medicine is working?

Your doctors will regularly check your health and tumour size. They will discuss the results with you and let you know if there are any signs the medicine is having an effect.

How to find out more

Sean Rossi

sean.rossi@nimbustx.com 857-600-8779 Official trial record

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