Study of INCB123667 in Subjects With Advanced Solid Tumors
This research is testing a new medicine called INCB123667 for adults with advanced solid tumours that have either grown worse on previous treatments, or for whom typical treatments aren't suitable. The main goals are to find out if the drug is safe, how well people tolerate it, and how it works in the body. Researchers will also explore if it has any effect on the tumours. The study has two main parts. First, participants will receive only INCB123667. In the second part, it will be given alongside other anti-cancer drugs like Palbociclib or Olaparib. This helps researchers understand the new drug on its own and when combined with existing treatments. This is an early phase study, meaning it's one of the first times this drug is being tested in people.
At a glance
What is this study about?
When you have an advanced solid tumour, and standard treatments aren't working as well as hoped, or can't be used, doctors are always looking for new options. This research study is looking at a new drug called INCB123667. The main aim is to understand more about it – how safe it is, how the body handles it, and if it shows any signs of helping people with certain advanced solid tumours.
This study is happening in different steps. In the first part, people will receive only the new drug, INCB123667, on its own. In the second part, researchers will combine INCB123667 with other anti-cancer medicines that are already used, such as Palbociclib, Bevacizumab, Olaparib, Paclitaxel, Ribociclib, or Fulvestrant. This helps doctors see if the new drug works better when combined with other known treatments.
Because this is an early-stage study (Phase 1), it means it's one of the first times this drug is being tested extensively in people. The information gathered will be crucial in deciding if this new drug could become a future treatment option for cancer. It aims to find the right dose and better understand its effects on the body.
Key takeaways
- This study evaluates a new drug, INCB123667, for advanced solid tumours.
- It's an early-stage (Phase 1) study focusing on safety and dosage.
- The drug will be tested alone and in combination with other cancer treatments.
- Participation requires your cancer to have progressed on prior treatments or if standard options aren't suitable.
- Specific tumour types like ovarian, breast, and stomach cancers are being looked at.
- You can stop participating at any time.
Who may be eligible?
To join this study, you must be 18 years old or older. You will need to have an advanced solid tumour that has either progressed despite previous treatments, or if you can't have standard treatments for other reasons.
Depending on which part of the study you join, the type of cancer will be important. For instance, some parts are looking specifically at ovarian, endometrial, stomach, or breast cancers (including HR+/HER2- breast cancer, also known as hormone-positive, HER2-negative breast cancer, and triple-negative breast cancer). Other advanced solid tumours might also be considered.
You would not be able to join if you have a significant heart condition, an unusual heart rhythm that your doctor thinks is important, or an active infection that needs strong medicines like antibiotics or antiviral drugs.
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 an advanced solid tumour?
- Has your cancer grown despite previous treatments, or are standard treatments not an option for you?
- Are you generally well and able to carry out most daily activities?
- Do you have a heart condition, an unusual heart rhythm, or a serious active infection that requires treatment?
What does participation involve?
Taking part in this study would involve regularly visiting the clinic. We can't give exact details here, but these visits will be for you to receive the study drug, have check-ups, and undergo tests to monitor your health and how the drug is affecting you. These tests might include blood samples, physical exams, and possibly tumour biopsies before you start treatment and at certain points during the study.
The study drug (INCB123667) will be given either alone or along with other anti-cancer treatments. The medical team will explain exactly how you would take these medicines. The duration of your participation would depend on how you respond to the treatment and the study plan, but you will have follow-up appointments after you stop taking the study drugs.
Before you decide to take part, the study team will explain everything in detail, including how long you might be involved, what tests you would have, and how often you'd need to come to the clinic.
Potential risks and benefits
Locations (42)
- City of Hope Medical CenterVerified postcodeDuarte, United States· Recruiting
- City of Hope-Lennar Foundation Cancer CenterVerified postcodeIrvine, United States· Recruiting
- Valkyrie Clinical TrialsVerified postcodeLos Angeles, United States· Recruiting
- Rocky Mountain Cancer Centers-Sky RidgeVerified postcodeLone Tree, United States· Recruiting
- Yale Cancer CenterVerified postcodeNew Haven, United States· Completed
- Mount Sinai Medical Center Comprehensive Cancer CenterVerified postcodeMiami Beach, United States· Recruiting
- Emory UniversityVerified postcodeAtlanta, United States· Completed
- Memorial Sloan Kettering Cancer CenterVerified postcodeNew York, United States· Completed
- New York Presbyterian/Weill CornellVerified postcodeNew York, United States· Completed
- Ny Cancer and Blood SpecialistsVerified postcodeShirley, United States· Not yet recruiting
- Carolina Bio-Oncology Institute, PllcVerified postcodeHuntersville, United States· Completed
- Cleveland ClinicVerified postcodeCleveland, United States· Withdrawn
Common questions
What kind of cancer is this study for?
This study is for people with advanced solid tumours, which means cancers like ovarian, breast, stomach, and other types, that have spread or are difficult to treat.
What is a 'Phase 1' study?
A Phase 1 study is an early stage of research. It's mainly to find out if a new drug is safe, what the right dose is, and how it works in the body.
Will I receive other cancer treatments too?
Yes, in the second part of the study, the new drug might be given together with other anti-cancer medicines that are already used.
Do I have to have had previous cancer treatment?
Yes, generally you need to have had previous treatment that didn't work as well as hoped, or if standard treatments are not suitable or available for you.
What are 'solid tumours'?
Solid tumours are growths of abnormal cells in organs or tissues, such as breast, lung, or bowel cancer, as opposed to blood cancers like leukaemia.
How to find out more
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Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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