Phase 2 Study of Ivonescimab for Advanced Salivary Gland Cancers
Sponsor: Glenn J. Hanna
ClinicalTrials ID:NCT06805617
This clinical trial is testing the safety and effectiveness of a new drug, Ivonescimab, in treating advanced salivary gland cancers that have spread or cannot be removed by surgery.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate how well Ivonescimab works and how safe it is for patients with advanced salivary gland cancers that have spread or cannot be surgically removed. Ivonescimab is a type of antibody that may help slow or stop the growth of cancer cells. Although it is not yet approved for salivary gland cancer, it has been used in lung cancer treatment. Participants will undergo various tests, including scans and blood tests, and will be monitored for about three years. Approximately 35 people will participate in this study, which is funded by Summit Therapeutics.
Description
This study is open to patients with advanced salivary gland cancer that cannot be cured or has returned or spread. The drug Ivonescimab is being tested to see if it can help control the cancer by blocking or slowing the growth of cancer cells. While Ivonescimab is not yet approved for this type of cancer, it has been used in lung cancer treatment. Participants will have regular clinic visits, imaging scans like X-rays and MRIs, blood and urine tests, and possibly tumor biopsies. The study will last about three years, including follow-up after treatment. Summit Therapeutics is providing the drug and funding for this research.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of salivary gland cancer that has returned, spread, or cannot be removed by surgery.
- Willing to provide a tumor sample if safe to do so.
- Must be 18 years or older.
- Must be in good general health, able to carry out normal activities or light work.
- Must have adequate blood cell counts and organ function based on specific medical tests.
- Must have a new or worsening tumor or symptoms within the last year.
- Must have at least one tumor that can be measured by scans.
- Must have recovered from any previous cancer treatments.
- Must be able to understand and sign a consent form.
- Women of childbearing potential must have a negative pregnancy test and use effective birth control during the study and for 120 days after the last dose.
- Men must use effective birth control during the study and for 120 days after the last dose.
Exclusion Criteria
- Cannot have active cancer spread to the brain or spinal cord unless stable and treated.
- Cannot receive other cancer treatments during the study.
- Cannot have uncontrolled illnesses like heart failure or infections.
- Cannot be pregnant or breastfeeding.
- Cannot have another active cancer needing treatment, except for certain skin cancers or low-risk prostate cancer.
- Cannot have significant autoimmune diseases, except stable thyroid conditions.
- Cannot have had major surgery or trauma recently.
- Cannot have a history of significant bleeding or need for blood thinners recently.
- Cannot have uncontrolled high blood pressure.
- Cannot have had recent severe heart or lung issues.
- Cannot have certain gastrointestinal issues or recent severe bleeding.
- Cannot have cancer invading major blood vessels or causing cavities in tumors.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Brigham and Women's Hospital | 02115 | Boston | Massachusetts |
| Dana-Farber Cancer Institute | 02115 | Boston | Massachusetts |
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