A Phase 1b, Multicenter Study to Determine the Dose, Safety, Efficacy and Pharmacokinetics of TRK-950 when Used in Combinations with Selected Anti-Cancer Treatment Regimens in Patients with Selected Advanced Solid Tumors
This research study, called a Phase 1b trial, is investigating a new medication called TRK-950. It's for adults, aged 18 and over, who have advanced solid cancers, which means cancers that form a lump or growth, such as bladder cancer, bowel cancer, stomach cancer, ovarian cancer, and melanoma. The main goals are to find the best and safest dose of TRK-950, understand any side effects it might have, and see how it works in the body when given with other standard cancer treatments. This study will also look at how effective TRK-950 is against these cancers. Both men and women can take part.
At a glance
What is this study about?
This study is looking into a new medication called TRK-950 for people who have several types of advanced solid cancers. 'Solid cancers' are those that form a lump or growth in the body, like bladder, bowel, stomach, or ovarian cancer. 'Advanced' means the cancer may have spread or come back after previous treatment.
The main aim of this research is to understand TRK-950 better. The study is a 'Phase 1b' trial, which means it's an early-stage study focusing on safety and finding the right dose. Researchers want to make sure the new medicine is safe for people to take and to find the highest dose that can be given without causing too many side effects. They will also look at how the body handles TRK-950 and get an early idea of how well it might work when combined with other common cancer treatments.
Taking part in a study like this helps doctors learn more about new treatments. This information is crucial for developing better ways to treat cancer in the future. Even though this is an early study, it's a vital step in discovering if TRK-950 could be a helpful new option for patients.
Key takeaways
- Tests a new medicine (TRK-950) for advanced solid cancers.
- Aims to find the safest dose and check for side effects.
- TRK-950 will be combined with other cancer treatments.
- Open to adults aged 18 and over, both men and women.
- Involves regular hospital visits for checks and tests.
- Helps advance understanding of new cancer treatments.
Who may be eligible?
This study is looking for adults who are 18 years old or older. Both men and women can join.
To be considered for the study, you must have an advanced solid cancer. This includes specific types like bladder cancer, a type of liver and bile duct cancer called cholangiocarcinoma, bowel cancer (colorectal cancer), ovarian cancer, cancer of the fallopian tubes, stomach cancer, melanoma (a type of skin cancer), kidney cancer, or other solid tumours.
There will be other important health checks to make sure the study medicine is safe for you. The study doctors will carefully review your medical history to confirm you meet all the necessary requirements to take part.
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 cancer diagnosis?
- Has your doctor discussed this study with you?
- Are you able to attend regular hospital appointments?
- Are you open to trying a new medicine in combination with existing treatments?
What does participation involve?
If you decide to take part in this study, you will receive the new medicine, TRK-950, alongside other cancer treatments. The study team will explain exactly what this involves, including how often you will take the medicine and for how long.
Your participation will involve regular visits to the hospital or clinic. During these visits, the study team will carry out health checks, take blood samples, and perform scans to monitor your health and see how you are responding to the treatment. These assessments help the doctors understand how the medicine is affecting you and your cancer.
The total length of time you will be in the study can vary depending on your individual response to treatment and will be discussed with you before you join. There will also be follow-up appointments after your treatment period to see how you are doing.
Potential risks and benefits
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Common questions
What is a 'Phase 1b' study?
It's an early-stage study focused on finding the safest dose of a new medicine and seeing how it works in the body, often combined with other treatments.
What kind of cancers are included in this study?
It includes advanced solid cancers like bladder, bowel, stomach, ovarian, melanoma, and kidney cancer, among others.
Will I be given the new medicine alone?
No, TRK-950 will be given along with other standard cancer treatments as part of this study.
How long will I be in the study?
The duration can vary for each person, depending on how you respond to the treatment. The study team will give you more details.
Can I stop participating in the study if I change my mind?
Yes, you can choose to leave the study at any time, and this will not affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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