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

Study of IBI3009 alone or in combination with other therapies for extensive-stage small cell lung cancer

This research study is investigating a new medicine, IBI3009, for people with extensive-stage small cell lung cancer. This means the cancer has spread beyond its original location in the lung. The study is especially interested in finding out if IBI3009 can help these patients, either by itself or when given alongside other treatments. Researchers will be checking how safe the medicine is and if it shows signs of being effective. This is an early-stage study, meaning it's one of the first times this medicine is being given to people. It’s a chance for doctors to learn more about new ways to treat this condition and improve future care for patients.

At a glance

Status
Authorised
Phase
Phase I and Phase II (Integrated)- First administration to humans
Sponsor
Fortvita Biologics (USA) Inc.
Enrolment target
30
Start
27 Apr 2026

What is this study about?

This clinical trial is designed to investigate a new treatment called IBI3009 for people who have extensive-stage small cell lung cancer. Extensive-stage means that the cancer has spread from where it started in the lung to other parts of the body. This type of cancer can be challenging to treat, so doctors are always looking for new and better options.

The main goal of this study is to see if IBI3009 is safe for people to take and to understand any side effects it might cause. Researchers also want to find out if this new medicine can help shrink the cancer or slow its growth. They will be testing IBI3009 on its own, and also in combination with other treatments that are already used for small cell lung cancer. This will help them understand the best way to use IBI3009 in the future.

This is a 'Phase I and Phase II' study. Phase I means it's one of the very first times this medicine is being given to people, so the focus is heavily on safety and finding the right dose. Phase II means that if the medicine seems safe, they will expand the study to learn more about how well it works. Taking part in studies like this is really important because it helps scientists develop new treatments that could improve outcomes for people with cancer.

Key takeaways

  • This study is for people with extensive-stage small cell lung cancer.
  • It's testing a new medicine called IBI3009, alone or with other treatments.
  • The main goals are to check the medicine's safety and see if it helps.
  • It's an early-stage study (Phase I and II), meaning it's focusing on initial safety and effectiveness.
  • Participation involves regular clinic visits for tests and monitoring.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. There's no upper age limit, so both younger and older adults may be able to take part. This study is open to both men and women.

Because this study is looking at a new treatment for extensive-stage small cell lung cancer, you must have this specific diagnosis to be considered. Doctors will also check other aspects of your health to make sure that taking part in the study would be safe for you. This often includes looking at your general health, other medical conditions you might have, and any other medicines you are currently taking.

Quick self-check
  • Are you 18 years old or older?
  • Have you been diagnosed with extensive-stage small cell lung cancer?
  • Are you able to attend regular clinic appointments for tests?
  • Are you willing to potentially receive a new, unproven medicine?

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

What does participation involve?

If you decide to participate, you would first go through a screening process to confirm you meet all the study requirements. This would involve medical tests and checks. If eligible, you would receive the study medication, IBI3009, according to the study plan. This might be on its own or with other treatments. You would have regular visits to the clinic for assessments, which could include blood tests, scans, and physical examinations, to monitor your health and see how the treatment is affecting you and your cancer. The total length of your participation would depend on how you respond to the treatment and the study design, but generally, clinical trials involve several months of active treatment and follow-up, followed by regular check-ins over a longer period.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as access to a new treatment before it's widely available, and your health will be closely monitored by a dedicated medical team. However, there are also potential risks, including side effects from the new medicine, which could be unknown or serious. There's also no guarantee that the treatment will be effective for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

  • Poland
  • Denmark
  • Spain

Common questions

What is 'extensive-stage small cell lung cancer'?

This means your small cell lung cancer has spread beyond the lung where it started to other parts of your body. Doctors are looking for new ways to treat this more advanced stage of cancer.

What is IBI3009?

IBI3009 is the name of a new medicine being tested in this study. We don't know much about it yet, which is why it's being studied. The aim is to see if it can help treat your type of lung cancer.

What does a 'Phase I and Phase II' study mean?

It means this is an early stage of testing. First, doctors will focus on making sure IBI3009 is safe and finding the right dose (Phase I). If it seems safe, they will then look more closely at how well it works against the cancer (Phase II).

Will I receive IBI3009?

If you join the study, you would receive IBI3009. The study is designed to test it either by itself or alongside other established cancer treatments.

Can I leave the study once I've joined?

Yes, absolutely. You can withdraw from the study at any point, for any reason, and this decision will not affect your future medical care.

How to find out more

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

Discussion

Community discussion

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