A Study of Sigvotatug Vedotin in Advanced Solid Tumors
This research study is investigating a new medication, sigvotatug vedotin, for individuals living with various advanced solid cancers. The main goals are to understand if it's safe to use, what potential side effects it might have, and if it can be an effective treatment for these cancers. The study will look at sigvotatug vedotin on its own and also together with other established cancer drugs like pembrolizumab, cisplatin, or carboplatin. The study has different parts: some to find the right dose, others to confirm safety and effectiveness, and some for people who haven't had previous treatment for their advanced cancer. This will help doctors learn more about this new drug and how it could potentially help patients.
At a glance
What is this study about?
This study is all about a new drug called sigvotatug vedotin. Scientists want to know if it can be a helpful treatment for several types of advanced cancer. 'Advanced cancer' means cancer that has spread or can't be removed with surgery. The doctors are trying to figure out two main things: first, is it safe to use, and what side effects might it cause? Second, does it actually work to treat these cancers?
The study will look at sigvotatug vedotin on its own and also in combination with other common cancer medicines you might have heard of, like pembrolizumab, or with standard chemotherapy drugs like cisplatin or carboplatin. There are different stages to the study. In some stages, they'll find the best dose of the new drug. In others, they'll focus on confirming its safety and seeing if it helps shrink tumors or stop them from growing. Some parts of the study will even include people whose cancer hasn't been treated yet.
By doing this research, doctors hope to gain a much better understanding of sigvotatug vedotin. This information is really important because it could lead to new treatment options for people with these types of solid tumors. It's about finding new ways to fight cancer and improve patients' lives, but it's important to remember that this is a research study, and new drugs are still undergoing testing.
Key takeaways
- This study is testing a new cancer drug called sigvotatug vedotin.
- It's for people with advanced forms of specific solid cancers.
- The study aims to check its safety, side effects, and effectiveness, alone and in combination with other treatments.
- It's a 'Phase 1' study, meaning it's an early stage of testing for new drugs.
- Participation involves regular hospital visits, tests, and closely monitored treatment.
- You can withdraw from the study at any time.
Who may be eligible?
This study is for adults aged 18 or older who have been diagnosed with certain types of advanced cancer that have spread or cannot be removed by surgery. These cancers include specific types of lung, head and neck, breast, oesophageal, stomach, ovarian, bladder, cervical, skin, and pancreatic cancers.
Whether you can join depends on which part of the study they are conducting. For some parts, you might need to have already tried and not responded to, or been unable to tolerate, standard cancer treatments. For other parts, especially those looking at combining sigvotatug vedotin with other drugs, you might need to be newly diagnosed with advanced cancer and not yet have had other treatments for it. Your doctor will carefully check if your specific cancer type and past treatments match the study's requirements.
In some cases, the study might also ask that your tumor can be easily reached to take a small sample (biopsy) to help researchers understand more about how the drug works. But don't worry, your own doctor will go through all these details with you to see if this study could be an option.
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 one of the listed advanced solid cancers (e.g., specific lung, breast, oesophageal, or stomach cancers)?
- Has your cancer spread, or can it not be fully removed by surgery?
- Are you willing to have regular hospital visits, blood tests, and scans?
- Are you able to provide a tumor sample (biopsy) if needed?
- Have you discussed your previous treatments with your doctor to see if you qualify for a specific part of the study?
What does participation involve?
If you decide to take part in this study, you will be given the study drug, sigvotatug vedotin, either by itself or along with other treatments like pembrolizumab or chemotherapy drugs (cisplatin or carboplatin). These will be given according to a schedule set by the study doctors.
Throughout the study, you will have regular visits to the hospital or clinic. During these visits, the medical team will monitor your health closely. This will involve physical examinations, blood tests, and scans (like CT scans or MRI scans) to see how you are responding to the treatment and to check for any side effects. You might also be asked to provide a tissue sample (biopsy) at the start of the study, and potentially later, to help researchers understand the drug better.
Your well-being is a priority, and the medical team will be there to support you. The total length of your participation will vary depending on how you respond to the treatment and which part of the study you are in. After initial treatment, there will be follow-up appointments to continue monitoring your health, even if you stop taking the study drug. You will always have the right to withdraw from the study at any time.
Potential risks and benefits
Locations (159)
- Alaska Oncology and HematologyVerified postcodeAnchorage, United States· Recruiting
- Highlands Oncology GroupVerified postcodeFayetteville, United States· Recruiting
- Highlands Oncology GroupVerified postcodeRogers, United States· Recruiting
- Highlands Oncology GroupVerified postcodeSpringdale, United States· Recruiting
- Providence Medical FoundationVerified postcodeAnaheim, United States· Recruiting
- Providence Medical FoundationVerified postcodeFullerton, United States· Recruiting
- Providence St. Jude Medical Center Virginia K Crosson and Infusion CenterVerified postcodeFullerton, United States· Recruiting
- Cancer and Blood Research Center, LLCVerified postcodeLos Alamitos, United States· Not yet recruiting
- Cancer and Blood Specialty ClinicVerified postcodeLos Alamitos, United States· Not yet recruiting
- Ronald Reagan UCLA Medical CenterVerified postcodeLos Angeles, United States· Recruiting
- The Regents of the University of CaliforniaVerified postcodeLos Angeles, United States· Recruiting
- UCLA Department of Medicine-Hematology/OncologyVerified postcodeLos Angeles, United States· Recruiting
Common questions
What is 'sigvotatug vedotin'?
It's a new experimental drug being tested to see if it can treat certain types of advanced cancer. It's not yet available as a standard treatment.
Why are they combining it with other drugs?
Researchers want to see if sigvotatug vedotin works better and is still safe when given together with other established cancer medications like pembrolizumab or chemotherapy.
What does 'advanced solid tumors' mean?
This refers to cancers that have spread to other parts of the body (metastatic) or cannot be fully removed by surgery. 'Solid tumors' are lumps or masses of tissue, unlike blood cancers.
Will I know if the drug is helping me?
Your medical team will perform regular tests and scans to monitor your condition and will discuss your progress and any changes with you.
Do I have to pay to be in the study?
No, you do not have to pay for the study drug or research-related procedures. However, standard medical care costs not related to the study are usually your responsibility.
How to find out more
Pfizer CT.gov Call Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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