RecruitingPHASE1INTERVENTIONAL

A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors

This study is investigating a new medication called CTIM-76 for people with certain types of advanced cancer that haven't responded well to previous treatments. These include ovarian cancer that has become resistant to platinum-based chemotherapy, and advanced testicular or endometrial cancers. CTIM-76 is designed to help your body's immune system recognise and attack cancer cells. This is an early-stage study (Phase 1) focused on carefully checking the safety of CTIM-76 and figuring out the best dose to use. Researchers also want to see if it shows any signs of working against the cancer. Participants will receive the drug until their cancer gets worse, side effects are too much, or they decide to stop, in consultation with their doctor. The study is a chance to try a new treatment approach that could potentially help those with hard-to-treat cancers.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Context Therapeutics Inc.

Enrolment target

156

Start

10 Jul 2024

Estimated completion

31 Dec 2028

Platinum-resistant Ovarian Cancer Testicular Cancer Endometrial Cancer

What is this study about?

This study is looking at a new treatment called CTIM-76 for certain cancers that are tricky to treat. These include ovarian cancer that has become resistant to standard chemotherapy (meaning the chemotherapy isn't working as well anymore), as well as advanced testicular cancer and advanced endometrial cancer. The main goal of this study is to see if CTIM-76 is safe and to find the best dose to give.

CTIM-76 is a special type of medicine that helps your body's own defence system, called the immune system, find and fight the cancer cells. It works by targeting a specific protein found on some cancer cells. This means it's designed to be more specific to cancer cells, hopefully leading to fewer side effects than traditional chemotherapy.

Because this is an early-stage (Phase 1) study, participants will be carefully monitored. The study starts by giving very small doses of CTIM-76 to a few people and slowly increasing the dose for new groups of participants. This helps the study team understand how safe the drug is and if there are any side effects. Once a safe and promising dose is found, more people will join to get that dose, so researchers can gather more information on its effects.

Key takeaways

This study tests a new immune-boosting drug, CTIM-76, for certain advanced cancers.
It's an early-stage study to check drug safety and find the best dose.
It targets ovarian, testicular, and endometrial cancers resistant to standard treatment.
Participants will receive the new drug and be closely monitored.
There's a chance of new side effects, but also potential for a new treatment option.
You can stop participating at any time.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or older. You must have a specific type of ovarian cancer (platinum-resistant), or advanced testicular or endometrial cancer where your cancer cells have a particular marker called CLDN6. Your cancer must also be measurable, meaning doctors can see it and follow its progress.

You also need to be generally well enough to take part. This means your body organs (like your heart, liver, and kidneys) need to be working adequately, and you should be able to carry out your daily activities with little difficulty. You should also not have other serious health problems that might make it unsafe for you to join.

There are also reasons why you might not be able to join. For example, if your cancer has spread to your brain or spinal cord in a specific way, or if you have a serious ongoing infection. You also can't be taking part in another clinical trial at the same time. Your study doctor will check all these points carefully to make sure the study is right 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?
Do you have ovarian (platinum-resistant), testicular, or endometrial cancer that has specific markers?
Is your cancer measurable by doctors?
Are you generally well and able to manage daily activities?
Are your major organs (like liver, kidneys) working well?
Are you *not* currently in another clinical trial?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive the study drug, CTIM-76, on a set schedule determined by the study. This will involve regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the drug is affecting your cancer. Researchers will pay very close attention to any side effects you might experience.

The treatment will continue as long as it is helping your cancer, you are not experiencing significant side effects, or you and your doctor decide it's best for you to stop. The total duration of your participation will vary depending on how you respond to the treatment. Even if you stop treatment, you will likely have follow-up visits to continue monitoring your health.

Potential risks and benefits

Taking part in this study means you could potentially benefit from a new treatment for your cancer that isn't available outside of clinical trials. This is especially relevant for people whose cancer hasn't responded to standard treatments. However, as CTIM-76 is a new drug, there may be unknown side effects. We also don't know for sure if it will work for everyone, or if it will work better than existing treatments. The research team will regularly check for any side effects and support you throughout. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (14)

University of Arkansas Winthrop P. Rockefeller Cancer Institute
Verified postcode
Little Rock, United States· Recruiting
Precision NextGen Oncology & Research Center
Verified postcode
Beverly Hills, United States· Withdrawn
SCRI at Denver Health
Verified postcode
Denver, United States· Recruiting
Dana-Farber Cancer Institute
Verified postcode
Boston, United States· Recruiting
John Theurer Cancer Center
Verified postcode
Hackensack, United States· Terminated
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States· Recruiting
Duke Cancer Institute
Verified postcode
Durham, United States· Recruiting
Gabrail Cancer Center
Verified postcode
Canton, United States· Withdrawn
Providence Cancer Institute of Oregon
Verified postcode
Portland, United States· Recruiting
Fox Chase Cancer Center
Verified postcode
Philadelphia, United States· Withdrawn
Women & Infants Hospital of Rhode Island
Verified postcode
Providence, United States· Recruiting
Vanderbilt-Ingram Cancer Center
Verified postcode
Nashville, United States· Recruiting

Common questions

What is CTIM-76?

CTIM-76 is a new medicine designed to train your immune system to attack cancer cells that have a specific protein called CLDN6.

What types of cancer is this study for?

It's for specific types of ovarian, testicular, and endometrial cancers that are advanced or haven't responded well to other treatments.

Why is this called a 'Phase 1' study?

Phase 1 means it's an early study focusing on checking the safety of the new drug and finding the right dose, rather than primarily proving how well it works.

Will I get the actual drug or a placebo?

Everyone in this study will receive the active study drug, CTIM-76. There is no placebo used in this particular trial.

Can I stop participating in the study if I want to?

Yes, you can choose to leave the study at any time, for any reason, and it will not affect your ongoing medical care.

How to find out more

Context Clinical Development

cntx-ctim76-101@contexttherapeutics.com 267-225-7416 Official trial record

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