All studies
RecruitingPHASE1, PHASE2INTERVENTIONAL

CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors

This research study is looking at a new treatment called CR-001 for adults who have advanced solid cancers that have spread or are difficult to treat. It's a Phase 1 and Phase 2 study, meaning it's an early step in testing new medicines. The main aims are to understand how safe CR-001 is, what side effects it might cause, and to find the best dose to use. Researchers also want to see how the body reacts to the drug and if it shows any signs of helping. This study could help find new ways to treat specific types of advanced cancer, including liver, womb, bowel, and lung cancers, among others.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
Crescent Biopharma, Inc.
Enrolment target
540
Start
17 Feb 2026
Estimated completion
01 Feb 2029

What is this study about?

This study is a clinical trial, which means it's a carefully planned research study to test a new medicine, CR-001. It's for adults who have solid cancers that are considered locally advanced (meaning they have grown quite a bit in the area where they started) or metastatic (meaning they have spread to other parts of the body). These types of cancers can be challenging to treat with current methods.

The main purpose of this study is to find out if CR-001 is safe to use and to identify the best dose that patients can tolerate without too many side effects. This is very important because before any new medicine can be used widely, doctors need to know it's safe and effective. This study also aims to understand how the drug works in the body and if it shows any early signs of helping to control the cancer.

This study is divided into different parts. Initially, a small number of participants will receive increasing doses of CR-001 to find safe levels. Later, more participants will join to confirm these doses and help decide on the best dose for future studies. The results of this trial will help researchers decide if CR-001 is promising enough to be tested in larger studies.

Key takeaways

  • This study is testing a new drug, CR-001, for adults with advanced solid cancers.
  • It aims to find a safe dose and understand how the drug works.
  • The study focuses on specific cancer types, including liver, womb, bowel, and lung cancers.
  • Participants will be monitored closely for safety and any changes in their cancer.
  • The treatment period can last up to two years, followed by long-term check-ups.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, adults must have specific types of advanced solid cancers that are locally advanced or have spread. They should generally be well enough to take part, meaning they have a life expectancy of at least three months and are able to carry out most daily activities without too much difficulty. Their body's organs, like the liver and kidneys, need to be working well, and they should have signs of cancer that can be measured by doctors.

The study is looking for people whose cancer has either not responded to, or who cannot take, standard treatments. This includes people with liver cancer, gallbladder or bile duct cancer, womb cancer, cervical cancer, ovarian cancer, stomach or gullet cancer, bowel cancer, and a type of lung cancer called non-small cell lung cancer.

There are also reasons why someone might not be able to join. For example, if they have had other cancers recently, certain serious heart problems, active infections, or uncontrolled autoimmune diseases. Also, people who have had significant side effects from previous treatments or who recently had major surgery might not be suitable.

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.

  1. Are you an adult aged 18 or over?
  2. Do you have locally advanced or metastatic solid cancer?
  3. Are you generally well enough to perform daily activities?
  4. Is your cancer type one of those listed (e.g., liver, womb, bowel, lung)?
  5. Have standard treatments for your cancer not worked, or can you not take them?
  6. Have you not had other cancers recently (within 3 years)?
Answer every question to see your result.

What does participation involve?

If you join this study, it will involve several stages. First, there will be a 'screening' period where doctors will check if you meet all the requirements. If you do, you will then enter the 'treatment period,' which could last up to two years. During this time, you will receive the study drug, CR-001.

Throughout the treatment period, you'll have regular visits for medical checks and safety assessments. This will include scans to see how your cancer is responding, and blood tests to check your general health and how the drug is working in your body. Even after you stop taking the treatment, you'll continue to have follow-up visits, including scans to monitor your cancer until it shows signs of getting worse. You will also have long-term follow-up calls every three months to check on your health and survival.

Potential risks and benefits

Taking part in this study means you might benefit from receiving a new potential cancer treatment that isn't widely available yet. It's an opportunity to try an experimental drug that could help control your cancer. However, like all new medicines, CR-001 might cause side effects, some of which could be serious. Researchers will carefully monitor you for any reactions. There's also no guarantee the drug will help your cancer. It's important to remember that participating is entirely voluntary, and you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (34)

  • Clinical Study Site
    Verified postcode
    Birmingham, United States· Recruiting
  • Clinical Study Site
    Verified postcode
    Los Angeles, United States· Recruiting
  • Clinical Study Site
    Verified postcode
    Denver, United States· Recruiting
  • Clinical Study Site
    Verified postcode
    Washington D.C., United States· Recruiting
  • Clinical Study Site
    Verified postcode
    Orlando, United States· Recruiting
  • Clinical Study Site
    Verified postcode
    Sarasota, United States· Recruiting
  • Clinical Study Site
    Verified postcode
    Detroit, United States· Recruiting
  • Clinical Study Site
    Verified postcode
    Grand Rapids, United States· Recruiting
  • Clinical Study Site
    Verified postcode
    New York, United States· Recruiting
  • Clinical Study Site
    Verified postcode
    Columbus, United States· Recruiting
  • Clinical Study Site
    Verified postcode
    Pittsburgh, United States· Recruiting
  • Clinical Study Site
    Verified postcode
    Nashville, United States· Recruiting

Common questions

What is a 'solid tumor'?

A solid tumor is a lump of abnormal tissue that forms from uncontrolled cell growth. Most cancers are solid tumors, like lung, breast, or bowel cancer, unlike blood cancers such as leukaemia.

What does 'locally advanced or metastatic' mean?

Locally advanced means the cancer has grown into nearby tissues but hasn't spread to distant parts of the body. Metastatic means the cancer has spread from where it started to other parts of the body.

What is the purpose of testing different 'doses'?

Testing different doses helps researchers find the amount of the drug that works best while causing the fewest and mildest side effects. This is called finding the 'optimal dose'.

Will I know if I'm getting the actual drug?

In some parts of the study, you might be given one of two different doses of CR-001. This study does not mention a placebo (dummy drug) arm, but it's always good to confirm with the study team.

How long will I be followed after treatment ends?

After your treatment with CR-001 stops, your health and cancer will be monitored through scans until your disease progresses. You'll also have long-term follow-up calls every three months to check on your well-being.

How to find out more

Crescent Clinical Trials

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

Interested in taking part?

Register your interest

Share your details and the research team for "CR-001 in Adult Participants With Locally Advanced or Metast…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.