A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer
This research study is looking into a new treatment called IDE849 for cancers that have a specific marker called DLL3. This includes a type of lung cancer called small cell lung cancer (SCLC), certain neuroendocrine cancers, and other solid tumours. The study wants to find out if IDE849 is safe, what dose works best, how well it fights cancer, and how the body handles it. Sometimes, IDE849 will be given on its own, and other times it will be combined with existing drugs like durvalumab or another new drug, IDE161. This is an early-stage study, meaning it's one of the first times this treatment is being tested in people.
At a glance
What is this study about?
This study is a clinical trial, which means it's a carefully planned way of testing new treatments to see if they are safe and effective for people with certain medical conditions. The main focus of this particular study is a new drug called IDE849. Researchers want to understand everything about IDE849: how safe it is, how the body uses and gets rid of it, if it causes any side effects, and most importantly, if it can help slow down or shrink certain types of cancer.
The cancers being looked at in this study all share a common feature: they have a special marker on their cells called DLL3. These cancers include small cell lung cancer (SCLC), which is a specific type of lung cancer, some types of neuroendocrine cancers, and other solid tumours that have this DLL3 marker. The study will test IDE849 in two ways: sometimes on its own, and sometimes combined with other medications that are either already approved or also being investigated (like durvalumab or IDE161). The hope is that IDE849, alone or in combination, could offer a new treatment option for people with these cancers.
This study has two main parts. The first part, called 'Dose Escalation,' is about finding the right dose of IDE849 that is both safe and has the best chance of working. Researchers will start with small doses and gradually increase them, carefully watching for any side effects. Once a good dose is found, the second part, called 'Dose Expansion,' will involve more people receiving this dose to gather more information on its safety and how well it works against the cancer. This phased approach helps ensure patient safety while finding the most effective treatment plan.
Key takeaways
- Tests a new drug (IDE849) for specific cancers.
- Targets a marker called DLL3 on cancer cells.
- Includes small cell lung cancer and certain neuroendocrine cancers.
- Checks for safety, best dose, and effectiveness.
- May involve IDE849 alone or with other drugs.
- It's an early-stage clinical trial (Phase 1/2).
Who may be eligible?
To be considered for this study, you would generally need to be at least 18 years old and have been diagnosed with certain types of cancer that have progressed or returned after standard treatments. These specific cancers include small cell lung cancer (SCLC), certain neuroendocrine cancers, or other solid tumours that have a special marker called DLL3. You would also need to be able to provide samples of your blood or tumour tissue for further testing.
In terms of your general health, doctors would check that you are well enough to participate. This includes having a generally good performance status (meaning you are mostly able to carry out your daily activities), have a reasonable life expectancy, and your organs are working well. You would also typically need to have at least one measurable tumour that doctors can track during the study. If you are a woman who could become pregnant, or a man with a partner who could, you would need to agree to use effective contraception during and for some time after the study treatment.
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 at least 18 years old?
- Do you have small cell lung cancer or another specific cancer type that has progressed after prior treatments?
- Are you generally well enough to participate in a study activity?
- Are you able to provide blood or tissue samples?
- Are you willing to use effective contraception if you are of childbearing potential or have a partner who is?
What does participation involve?
If you join this study, you will receive either the new drug IDE849 on its own or IDE849 combined with other medications. The study will involve regular visits to the clinic for check-ups, blood tests, and scans to see how you are responding to the treatment and to monitor your health. Your specific schedule of visits and tests will depend on which part of the study you are in and which treatment group you are assigned to. The research team will track your health carefully during the treatment period and for a set time after your last dose of the study drug to ensure your safety and gather all necessary information.
Potential risks and benefits
Locations (39)
- Sarah Cannon Research Institute at HealthONEVerified postcodeDenver, United States· Recruiting
- Mayo Clinic Hospital - FloridaVerified postcodeJacksonville, United States· Not yet recruiting
- Sarah Cannon Research Institute at Florida Cancer SpecialistsVerified postcodeOrlando, United States· Not yet recruiting
- Piedmont Physicians Medical Oncology - AtlantaVerified postcodeAtlanta, United States· Not yet recruiting
- The University of Chicago Medical Center - Duchossois Center for Advanced MedicineVerified postcodeChicago, United States· Not yet recruiting
- OSF HealthCare Cancer InstituteVerified postcodePeoria, United States· Not yet recruiting
- Fort Wayne Medical Oncology and Hematology, Inc. - Fort Wayne North OfficeVerified postcodeFort Wayne, United States· Not yet recruiting
- Dana-Farber Cancer InstituteVerified postcodeBoston, United States· Not yet recruiting
- Trinity Health-IHA Medical Group - Hematology Oncology - Ann Arbor CampusVerified postcodeAnn Arbor, United States· Not yet recruiting
- The Cancer and Hematology CentersVerified postcodeGrand Rapids, United States· Recruiting
- Columbia University Medical Center - Herbert Irving PavilionVerified postcodeNew York, United States· Recruiting
- Weill Cornell Medicine - Cutaneous Oncology and Melanoma ProgramVerified postcodeNew York, United States· Not yet recruiting
Common questions
What is DLL3?
DLL3 is a specific marker that can be found on the surface of some cancer cells. This study is testing a drug designed to target cells with this marker.
What does 'Phase 1/2' mean for a study?
This means it's an early-stage study. Phase 1 focuses on finding a safe dose and understanding side effects. Phase 2 then looks at how well the drug works at that safe dose in more people.
Will I know if I'm getting the new drug or not?
This study is 'open-label,' meaning both you and your study doctor will know which treatment you are receiving (IDE849 alone or in combination with other drugs).
Can I continue my other cancer treatments while on this study?
Generally, no. For most parts of this study, you would have finished or progressed after your previous cancer treatments before starting the study drug.
What happens after the study ends?
The study team will continue to follow up on your health after your last dose of the study drug for a set period to monitor your well-being.
How to find out more
IDEAYA Clinical Trials
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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