A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
This clinical trial is looking at a new investigational medicine called INCA33890 for adults with advanced or spreading solid cancers. These are cancers that have grown or spread to other parts of the body. The main goal is to understand how safe INCA33890 is, what types of side effects it might cause, and to figure out the best dose to use in future studies. Researchers will also look at how well people tolerate the treatment. This is a very early-stage study, meaning it's one of the first times this medicine is being tested in people. It will involve carefully monitoring participants to learn as much as possible about INCA33890.
At a glance
What is this study about?
This study is a Phase 1 clinical trial, which means it's an early-stage study where researchers are testing a new medicine called INCA33890 for the first time in a small group of people. The main purpose of this type of study is to see how safe the new medicine is, rather than how effective it is at treating cancer. Researchers want to understand if it causes any harmful side effects and how well people can tolerate the treatment.
The trial is open to adults who have solid cancers that are advanced or have spread to other parts of the body. 'Solid tumours' refer to cancers that form a lump, like breast, lung, or bowel cancer, rather than blood cancers. 'Advanced' or 'metastatic' means the cancer has either grown beyond its original site or has spread to other areas of the body. Participants in this study will have already tried other available treatments, or these treatments are not suitable for them.
Alongside INCA33890, some participants might also receive other standard cancer treatments like FOLFIRI, FOLFOX, bevacizumab, or cetuximab. By carefully monitoring participants, the researchers hope to determine the highest dose of INCA33890 that can be given without causing unacceptable side effects. This information is crucial for planning future, larger studies to see if the medicine can help treat cancer effectively.
Key takeaways
- This study is testing a new medicine called INCA33890 for advanced solid cancers.
- It's a Phase 1 study, focusing on safety and finding the right dose.
- Participants will have advanced or spreading solid tumours and may have tried other treatments.
- Enrollment involves regular clinic visits, tests, and biopsies.
- You might receive INCA33890 alone or with other standard cancer drugs.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old and have a confirmed diagnosis of an advanced or spreading solid cancer. For some parts of the study, you must have already tried other cancer treatments that didn't work or weren't right for you. Your general health and ability to do daily activities should also be good, which doctors measure using a score called ECOG performance status.
You would also need to be willing to have a small tissue sample (biopsy) taken from your tumour before and during the treatment, as this helps researchers understand how the medicine is working. Your cancer should also be measurable on scans so doctors can track any changes.
However, there are reasons you might not be able to join. For example, if you have other cancers that are active, unmanaged heart problems, recent serious infections, uncontrolled autoimmune diseases needing strong medication, or if your brain or spinal cord cancer has spread or is untreated. Also, if you've had an organ transplant, have certain infectious diseases like active hepatitis or HIV, or are on high doses of steroids, you might not be eligible.
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 or spreading solid cancer?
- Are you generally in good health and able to manage daily activities?
- Are you willing to have small tissue samples (biopsies) taken from your tumour?
- Have you discussed any other health conditions you have with the study team?
- Have you already received different treatments for your cancer, or are current treatments not suitable for you?
What does participation involve?
If you join this study, you will receive the investigational medicine INCA33890, possibly along with other standard cancer treatments. This will involve regular visits to the hospital or clinic for treatment, blood tests, and scans to monitor your health and how the medicine is affecting your cancer. Researchers will pay close attention to any side effects you might experience.
You will also need to have biopsies taken from your tumour at certain times during the study. These are small procedures where doctors remove a tiny piece of tissue for analysis. The total length of your participation will depend on how you respond to the treatment and the study plan, but you will be closely monitored throughout.
Potential risks and benefits
Locations (36)
- The Angeles Clinic and Research InstituteVerified postcodeLos Angeles, United States· Recruiting
- Valkyrie Clinical TrialsVerified postcodeLos Angeles, United States· Recruiting
- Dana Farber Cancer InstituteVerified postcodeBoston, United States· Recruiting
- Cancer and Hematology Centers of Western Michigan-Start MidwestVerified postcodeGrand Rapids, United States· Recruiting
- Hackensack University Medical CenterVerified postcodeHackensack, United States· Recruiting
- Nyu Langone Health - Long Island HospitalVerified postcodeMineola, United States· Recruiting
- Laura and Isaac Perlmutter Cancer CenterVerified postcodeNew York, United States· Recruiting
- University of PennsylvaniaVerified postcodePhiladelphia, United States· Recruiting
- Lifespan Cancer Research InstituteVerified postcodeProvidence, United States· Recruiting
- University of Texas Md Anderson Cancer CenterVerified postcodeHouston, United States· Recruiting
- South Texas Accelerated Research TherapeuticsVerified postcodeSan Antonio, United States· Recruiting
- Rigshospitalet Uni of Hospital of CopenhagenVerified postcodeCopenhagen, Denmark· Recruiting
Common questions
What is a 'solid tumour'?
A solid tumour is a cancer that forms a lump or mass of tissue, like in the breast, lung, or bowel, rather than a blood cancer like leukaemia.
What does 'advanced' or 'metastatic' cancer mean?
It means the cancer has either grown beyond its original site or has spread to other parts of the body.
What is a Phase 1 study?
A Phase 1 study is the first stage of testing a new medicine in people. The main goal is to check how safe it is and find the best dose, rather than how well it treats the disease.
Will I get cancer treatment if I join this study?
Yes, you will receive the new investigational medicine INCA33890, and possibly some established cancer treatments, as part of the study plan.
Can I stop participating in the study at any time?
Yes, your participation is voluntary, and you can choose to leave the study at any point without it affecting your future medical care.
How to find out more
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Always speak to your GP or specialist before deciding to take part in a study.
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