A Phase I/II Study of DYP688 in Patients With Metastatic Uveal Melanoma and Other GNAQ/11 Mutant Melanomas
This study is investigating a new medication called DYP688 for people who have advanced uveal melanoma (a type of eye cancer that has spread) or other rare melanomas with specific genetic changes (called GNAQ/11 mutations). The study has two main parts. In the first part, researchers will carefully increase the dose of DYP688 to find the safest and most effective amount. In the second part, they will give this dose to more patients to see how well it works to shrink or control the cancer. This research aims to understand if DYP688 could be a helpful treatment option for these conditions.
एक नजर में
यह अध्ययन किस बारे में है?
This research study is looking into a new medication, DYP688, for people with specific types of melanoma that have unfortunately spread to other parts of the body. The main focus is on uveal melanoma, which is a rare type of cancer that starts in the eye. It's also for other less common melanomas that have particular genetic changes, known as GNAQ/11 mutations.
The study has two stages. The first stage is about finding the right dose of DYP688. Researchers will start with a low dose and gradually increase it in a small group of patients, carefully watching for any side effects. This helps them find a dose that is both safe and has the best chance of working against the cancer. Once a safe and effective dose is found, the study moves to the second stage.
In the second stage, more patients will receive the identified dose. This larger group will include people with uveal melanoma, both those who have tried a previous treatment called tebentafusp and those who haven't. There might also be a small group of people with other melanomas that have the specific GNAQ/11 genetic changes. The overall goal is to understand how well DYP688 works to control or shrink the cancer and to continue monitoring its safety.
मुख्य निष्कर्ष
- Tests a new drug (DYP688) for advanced uveal melanoma and GNAQ/11 mutant melanomas.
- Aims to find a safe dose and see how well it works.
- Involves regular check-ups, blood tests, and scans.
- भागीदारी स्वैच्छिक है, और आप किसी भी समय वापस ले सकते हैं।.
- Potential for a new treatment, but also possible unknown side effects.
कौन पात्र हो सकता है?
To be considered for this study, most participants need to be at least 18 years old. However, for some parts of the study, younger individuals, aged 12 and above, might be able to take part if allowed in their country, provided they weigh at least 40 kg (about 6 stone 4 pounds). All participants need to be well enough to carry out most daily activities without too much difficulty.
For those with uveal melanoma that has spread, you might be eligible whether you've had previous treatments or not, as long as your cancer has progressed. If you have another type of melanoma (not uveal) that has spread, you would need to have tried all standard treatments or have no other good treatment options, and your cancer must have the specific GNAQ/11 genetic changes.
It's important that you are able and willing to have biopsies (taking small tissue samples) if the study requires them, though exceptions might be considered if a biopsy isn't medically possible for you.
क्या यह अध्ययन आपके लिए उपयुक्त हो सकता है?
यह देखने के लिए इन त्वरित प्रश्नों का उत्तर दें कि क्या आप पात्र हो सकते हैं। यह केवल एक मार्गदर्शिका है — अंतिम निर्णय शोध टीम द्वारा लिया जाता है।.
- Are you generally aged 18 or older (or 12+ if specific conditions apply)?
- Do you have uveal melanoma that has spread, or another melanoma with specific GNAQ/11 genetic changes?
- Are you able to manage most of your daily activities without much help?
- Are you willing and able to undergo study-required biopsies?
भागीदारी में क्या शामिल है?
If you decide to join this study, you will be taking a new medication called DYP688. The study involves regular visits to the clinic for assessments. These will include check-ups by doctors, blood tests, and scans to see how your body is responding to the treatment and whether the cancer is changing. You might also need to have biopsies collected to understand more about your cancer and how the drug is working. The exact number of visits and tests will be explained in detail by the study team, and it will depend on which part of the study you are in. You will take the medication for as long as it benefits you and you tolerate it well, with regular follow-up appointments after you stop taking the drug.
संभावित जोखिम और लाभ
स्थान (11)
- Massachusetts General Hospital Hematology Oncologyसत्यापित पोस्टकोडबोस्टन, संयुक्त राज्य अमेरिका
- Columbia University Medical Center- New York Presbyterian Onc Deptसत्यापित पोस्टकोडन्यूयॉर्क, संयुक्त राज्य अमेरिका
- Memorial Sloane Kettering Cancer Center MSKCCसत्यापित पोस्टकोडन्यूयॉर्क, संयुक्त राज्य अमेरिका
- नोवार्टिस जांच स्थलसत्यापित पोस्टकोडवेस्टमीड, ऑस्ट्रेलिया
- नोवार्टिस जांच स्थलसत्यापित पोस्टकोडमेलबर्न, ऑस्ट्रेलिया
- नोवार्टिस जांच स्थलसत्यापित पोस्टकोडपेरिस, फ्रांस
- नोवार्टिस जांच स्थलसत्यापित पोस्टकोडएस्सेन, जर्मनी
- नोवार्टिस जांच स्थलसत्यापित पोस्टकोडहाइडेलबर्ग, जर्मनी
- नोवार्टिस जांच स्थलसत्यापित पोस्टकोडलिडेन, नीदरलैंड्स
- नोवार्टिस जांच स्थलसत्यापित पोस्टकोडमैड्रिड, स्पेन
- नोवार्टिस जांच स्थलसत्यापित पोस्टकोडZurich, Switzerland
सामान्य प्रश्न
What is uveal melanoma?
Uveal melanoma is a rare type of cancer that begins in the eye. In this study, we are looking at it when it has spread to other parts of the body.
What are GNAQ/11 mutations?
These are specific genetic changes found in some melanomas. This study is for people whose cancer has these particular changes.
What does 'First in Human' mean?
It means this is one of the first times this new drug, DYP688, is being tested in people. This is a very early stage of research.
Will I get a placebo (dummy drug)?
No, in this study, everyone will receive the active medication, DYP688. There is no placebo group.
अध्ययन कितने समय तक चलता है?
You will continue to receive the study drug for as long as it is helping you and you are tolerating it well. There will be follow-up appointments after you stop the drug.
और अधिक जानने के लिए कैसे पता करें
किसी अध्ययन में भाग लेने का निर्णय लेने से पहले हमेशा अपने जीपी या विशेषज्ञ से बात करें।.
चर्चा
समुदाय चर्चा
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