Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies

This research study is investigating a new medication, CFI-402411, for people with advanced cancers. It's being tested alone and in combination with another drug, pembrolizumab. The main goals are to understand if CFI-402411 is safe for patients and to see how well it works. This study is for those whose cancer has continued to grow despite having received other treatments. CFI-402411 is an experimental drug designed to boost the body's immune response against cancer. Researchers hope that combining it with pembrolizumab, which also helps the immune system, could offer a more effective way to fight these cancers. The study will help determine the right dose for future research.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Treadwell Therapeutics, Inc

Enrolment target

170

Start

31 Aug 2020

Estimated completion

01 Dec 2025

Advanced Solid Malignancies

What is this study about?

This study is looking into a new experimental medicine called CFI-402411 for people with advanced solid cancers. 'Advanced' means the cancer has spread or is difficult to treat. The study wants to find out if this new drug is safe to use and whether it can help treat these cancers. Doctors will be giving CFI-402411 either on its own or together with another anti-cancer medicine called pembrolizumab (which you might have heard of).

CFI-402411 is a tablet you take by mouth. It works by blocking something in the body called HPK1. Scientists believe that by blocking HPK1, it could help wake up your body's own immune system to fight the cancer cells. Pembrolizumab also helps the immune system, so researchers hope that using these two drugs together might make the treatment even stronger against the cancer.

This is one of the first times this new drug is being tested in people. The information gathered from this study will help doctors understand how much of the drug to give and how often. It will also help them figure out which patients might benefit most from this treatment in future studies. The hope is that CFI-402411, especially when combined with pembrolizumab, could become a new way to help people with advanced cancers.

Key takeaways

This study is for people with advanced a variety of solid cancers that have not responded to previous treatments.
It's testing a new drug, CFI-402411, alone or combined with pembrolizumab, to see if it's safe and effective.
CFI-402411 is an oral tablet designed to help your immune system fight cancer.
Participation involves regular clinic visits, blood tests, and scans.
You must be over 18 and meet specific health and cancer history criteria.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. Your cancer must have spread or come back, and you should have already tried at least one, but no more than three, different treatments for it. Doctors also need to be able to measure your cancer, for example, through scans, to see if the treatment is working. Your doctors would also assess your general health and how well you can do your usual daily activities, which they'll score as a 0 or 1. This means you are generally active and able to look after yourself.

For some parts of the study, your specific type of advanced cancer might matter. This includes cancers like certain lung cancers, skin cancers, head and neck cancers, bladder cancers, kidney cancers, certain breast cancers, womb cancers, and stomach cancers, among others. These are cancers that haven't responded to standard treatments or for which no standard treatment is available.

Ultimately, a study doctor will review all your medical information to see if this study is suitable 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?
Has your advanced cancer already been treated with 1 to 3 different therapies that haven't fully worked?
Can your doctors measure your cancer on scans or tests?
Are you generally active and able to look after yourself (your doctor will assess this)?
Have you been told you have one of the specific cancer types listed in the study, and that standard treatments are not available or suitable?
Are you willing and able to take a daily tablet?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the experimental drug, CFI-402411, which is a tablet you take by mouth. Depending on which part of the study you are in, you might also receive pembrolizumab alongside CFI-402411. You would have regular visits to the clinic where doctors and nurses will monitor your health very closely. These visits will include physical examinations, blood tests, and scans (like CT or MRI scans) to see how the treatment is affecting your body and your cancer.

The study usually starts with finding the right dose of the new drug. After that, more people might take part to see how well the drug works at that dose. The total length of your participation would depend on how your body responds to the treatment and the study plan, but it will involve ongoing check-ups. You would always be informed about what to expect at each stage.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The main potential benefit is that this new experimental treatment, CFI-402411, possibly with pembrolizumab, might help control your cancer where other treatments haven't. However, there's no guarantee it will work for everyone, or at all. As this is a new drug, there could be side effects that are not yet fully known, common ones, or serious ones. The study team will explain all known potential risks to you in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

University of California San Diego
Verified postcode
La Jolla, United States
The Angeles Clinic
Verified postcode
Los Angeles, United States
Yale Cancer Center
Verified postcode
New Haven, United States
Florida Cancer Specialists
Verified postcode
Sarasota, United States
START - Mid-West
Verified postcode
Grand Rapids, United States
SCRI - Nashville
Verified postcode
Nashville, United States
MD Anderson
Verified postcode
Houston, United States
START - San Antonio
Verified postcode
San Antonio, United States
Virginia Cancer Specialist
Verified postcode
Fairfax, United States
Cross Cancer Institute
Verified postcode
Edmonton, Canada
The Ottawa Hospital
Verified postcode
Ottawa, Canada
Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada

Common questions

What is 'advanced solid malignancy'?

This refers to cancers that have spread to other parts of the body or are difficult to treat, and which originated in a solid organ like the lungs, breast, or bowel.

Is CFI-402411 already available as a medicine?

No, CFI-402411 is an investigational drug, meaning it's still in the testing phase and not yet approved for general use.

What is the purpose of combining CFI-402411 with pembrolizumab?

Both drugs aim to boost your immune system against cancer, so researchers hope that using them together might be more effective than using either drug alone.

Will I know if I'm getting the new drug or not?

In this specific study, everyone who participates will receive either CFI-402411 alone or in combination with pembrolizumab. There isn't a placebo group in this trial.

What happens if the treatment causes bad side effects?

The study team will closely monitor you for any side effects. If they occur, they will provide appropriate medical care and may adjust or stop your treatment if needed, for your safety.