AuthorisedPhase I and Phase II (Integrated)- First administration to humansInterventional

A Phase 1/2, Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamic, and Antitumor Activity of CR-001 in Adult Participants with Locally Advanced or Metastatic Solid Tumors.

This research study is investigating a new medication called CR-001 for adults who have locally advanced or metastatic (spreading) solid cancers. It's a 'first-in-human' study, meaning CR-001 hasn't been widely used in people before. The main goals are to find a safe dose and understand any side effects. Researchers will also look at how the body handles the medicine and whether it helps shrink tumors or stop them from growing. This is a phased study, starting with small groups to ensure safety before expanding to more people. By carefully observing participants, doctors hope to learn if CR-001 could be a future treatment option.

At a glance

Status

Authorised

Phase

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

Sponsor

Crescent Biopharma Inc.

Enrolment target

Start

02 Jun 2026

Locally Advanced or Metastatic Solid Tumors

What is this study about?

This study is about a new medicine called CR-001, designed for adults who have advanced solid cancers that have either grown into nearby tissues or spread to other parts of the body. When a new medicine is developed, it needs to go through several careful steps before it can be offered to everyone. This study is one of the very first steps, called a Phase 1/2 trial, meaning it's the first time CR-001 is being given to people.

The main purpose of this study is to find out if CR-001 is safe and what dose can be given without causing too many problems. The doctors will be closely watching for any side effects and how your body reacts to the medicine. They also want to understand how your body takes in, uses, and gets rid of the medicine. This is important for finding the best way to give it. Finally, they will be looking to see if CR-001 has any positive effects on the cancer, such as shrinking tumors or stopping them from growing.

Taking part in a study like this helps doctors learn more about new ways to fight cancer. Your involvement could help others in the future by providing crucial information about this new potential treatment.

Key takeaways

This study is for adults with advanced solid cancers.
It's testing a new medicine called CR-001 for the first time in people.
The main goals are to find a safe dose and look for side effects.
Researchers will also check if CR-001 helps shrink tumors or slow their growth.
Your health will be monitored very closely throughout the study.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

Crucially, you must have a solid tumor that is considered 'locally advanced' (meaning it has grown into nearby areas) or 'metastatic' (meaning it has spread to other parts of your body). The doctors running the study will check other medical details to make sure this study is right for you and that you meet all the health requirements for safety.

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 a solid cancer?
Has your cancer grown locally or spread to other parts of your body?
Are you able to attend regular hospital visits and appointments?
Are you willing to follow all study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given the study drug, CR-001. The amount you receive will be carefully increased in small steps for different groups of patients until a safe dose is found. You will have regular visits to the hospital or clinic, where the study doctors and nurses will monitor your health very closely. These visits will include check-ups, blood tests, and scans to see how you are responding to the medication and to check for any side effects. You will also have follow-up appointments after you stop taking the drug to monitor your health. The total time you spend in the study will depend on how you respond to the treatment and your individual situation.

Potential risks and benefits

Like all medical treatments, CR-001 could have potential benefits, such as shrinking your tumor or slowing its growth, but there's no guarantee the treatment will work for you. There are also potential risks, including side effects from the medication. The study team will explain all the known and potential risks in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What kind of cancer is this study for?

This study is for adults with solid cancers that have either grown locally or spread to other parts of the body.

What is CR-001?

CR-001 is a new investigational medicine that is being tested for the first time in people as a potential cancer treatment.

What does 'Phase 1/2' mean?

This means it's one of the first stages of testing a new drug in humans; it focuses on finding a safe dose and seeing if it has any effects on the cancer.

Will I know if the medicine is working?

The study doctors will conduct regular scans and tests to monitor your cancer and will discuss the results with you.

How long does the study last?

The length of your participation will depend on how you respond to the treatment and your individual health situation. The study team will give you more details.