All studies
Active not recruitingPHASE1INTERVENTIONAL

A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic Malignancies

This study is investigating a new medicine called KQB198 for adult patients with advanced blood cancers. The main goals are to find out if KQB198 is safe to use and whether it can help reduce the size of the cancer. They are also looking to determine the best dose of KQB198, both when used on its own and when combined with other cancer treatments. Another important part of the study is to understand how KQB198 works within the body. Participants will take KQB198 daily and will have regular clinic visits, more frequently at the beginning of the study.

At a glance

Status
Active not recruiting
Phase
PHASE1
Sponsor
Kumquat Biosciences Inc.
Enrolment target
13
Start
09 Dec 2024
Estimated completion
01 Mar 2027

What is this study about?

You might be hearing about a new research study that's looking into a medicine called KQB198. This study is for adults who have certain types of advanced blood cancers. Blood cancers affect your blood cells and bone marrow, which is the soft tissue inside your bones that makes blood cells. When we say 'advanced,' it means the cancer has progressed.

The main idea behind this study is to see if KQB198 can be a helpful new treatment option. Researchers want to understand two key things: first, how safe KQB198 is for people to take, and second, whether it can actually help to make the cancer smaller. They're also trying to figure out the right amount, or 'dose,' of KQB198 to give, both when it's used alone and when it's given alongside other cancer medicines.

Finding new treatments for serious illnesses like advanced blood cancers is very important. Studies like this help doctors learn more about promising new medicines, which could one day lead to better ways to help patients. By taking part, you would be helping medical science move forward.

Key takeaways

  • This study is testing a new medicine called KQB198 for adult blood cancers.
  • It aims to find out if KQB198 is safe and can shrink tumours.
  • Participation involves taking KQB198 daily and regular clinic visits.
  • It's for specific blood cancer patients who've tried other treatments.
  • Your health would be closely watched, and you can leave the study at any time.

Who may be eligible?

This study is for adults, aged 18 and over, who have a specific type of blood cancer called Philadelphia chromosome-positive (Ph+) Chronic Myeloid Leukaemia (CML) in the chronic phase.

To be considered, your body's organs need to be working well. If you have Ph+ CML, you might be eligible if you've already tried at least two other types of treatments (called tyrosine kinase inhibitors or TKIs) for your cancer, but they either stopped working or caused side effects you couldn't tolerate. Your doctor would help decide if this study is a good option for you based on this.

There are some reasons why you might not be able to join. For instance, if your CML is in a more advanced stage (called accelerated or blast phase), or if you've already had a very similar type of treatment to KQB198. Also, if you have certain bowel problems, serious heart issues, or a lung condition called interstitial lung disease, you wouldn't be able to take part. It's important that your body can absorb the study medicine properly.

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 18 years old or older?
  2. Do you have Philadelphia chromosome-positive (Ph+) Chronic Myeloid Leukaemia (CML)?
  3. Have you already tried at least two other TKI treatments for your CML?
  4. Are your body's organs (like your liver and kidneys) generally working well?
  5. Do you NOT have serious heart, lung (like interstitial lung disease), or digestive system problems?
  6. Is your CML still in the 'chronic phase' and not in an advanced 'accelerated' or 'blast' phase?
Answer every question to see your result.

What does participation involve?

If you join this study, you would take the medicine KQB198 every day. Sometimes it's given alone, and sometimes it's given साथ with another cancer medicine. During the first eight weeks, you'd have about eight clinic visits. After that, you'd visit the clinic less often, typically once a month (every four weeks). These visits are to check how you're doing, understand how the medicine is affecting you, and ensure your safety. The total length of your participation would depend on how your body responds to the treatment.

Potential risks and benefits

Taking part in this study could potentially offer a new treatment option for your advanced blood cancer, especially if other treatments haven't worked well for you. However, as with any new medicine, there might be side effects or risks that doctors don't fully know yet. Your health and safety will be closely monitored throughout the study. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (29)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of California, San Francisco (UCSF)
    Verified postcode
    San Francisco, United States
  • Colorado Blood Cancer Institute
    Verified postcode
    Denver, United States
  • Moffitt Cancer Center
    Verified postcode
    Tampa, United States
  • Barbara Ann Karmanos Cancer Institute
    Verified postcode
    Detroit, United States
  • Duke University Medical Center
    Verified postcode
    Durham, United States
  • Oncology Hematology Cincinnati
    Verified postcode
    Cincinnati, United States
  • Sarah Cannon Research Institute (SCRI) - Transplant and Cellular Therapy Operations
    Verified postcode
    Nashville, United States
  • Texas Oncology Austin Central
    Verified postcode
    Austin, United States
  • MD Anderson Cancer Center
    Verified postcode
    Houston, United States
  • Virginia Cancer Specialists
    Verified postcode
    Fairfax, United States
  • CHRU de Tours - Hopital Bretonneau
    Verified postcode
    Tours, France
  • AP-HM - Hopital de la Timone
    Verified postcode
    Marseille, France

Common questions

What is KQB198?

KQB198 is a new medicine being studied to treat certain types of blood cancer in adults.

What kind of cancer is this study for?

It's for adults with advanced Philadelphia chromosome-positive (Ph+) Chronic Myeloid Leukaemia (CML) in the chronic phase.

How often will I need to go to the clinic?

You'll have about eight visits in the first two months, and then one visit every four weeks after that.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time, and it won't affect your regular medical care.

Is KQB198 a new drug?

Yes, KQB198 is an experimental drug, meaning it's still being tested to see if it's safe and effective.

How to find out more

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

Discussion

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