Study on 9-ING-41 and Carboplatin for Advanced Salivary Gland Cancer
Sponsor: Glenn J. Hanna
ClinicalTrials ID:NCT05010629
This clinical trial is testing a new treatment combining the drug 9-ING-41 with chemotherapy (carboplatin) to see if it can help treat advanced salivary gland cancers that cannot be cured or have spread.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate if a new drug, 9-ING-41, when used with the chemotherapy drug carboplatin, can help treat advanced salivary gland cancers. 9-ING-41 is not yet approved by the FDA for any disease, but it may help slow cancer growth by blocking a protein that encourages cancer cells to grow. The study will involve regular check-ups every three weeks for up to a year, as long as the treatment is safe and the cancer does not worsen. About 33 people are expected to participate in this study, which is supported by Actuate Therapeutics.
Description
This study is testing a new drug called 9-ING-41, which is thought to block a protein that helps cancer grow, in combination with the chemotherapy drug carboplatin. The study is for patients with advanced salivary gland cancer that cannot be cured or has spread. The FDA has not approved 9-ING-41 yet, but carboplatin is already used for treating various cancers. Participants will be screened for eligibility and will receive the treatment, with follow-up visits every three weeks for up to a year, as long as the treatment is safe and effective. The study aims to see if this combination can slow down cancer growth, especially in cases where previous treatments have not worked. Actuate Therapeutics is providing the study drug and supporting the trial.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of salivary gland cancer that has come back, spread, or cannot be removed by surgery.
- Willing to provide a sample of tumor tissue from a previous biopsy or surgery.
- Must be 18 years or older.
- Must be in relatively good health, with a performance status score between 0 and 2.
- Must have adequate organ and bone marrow function as shown by specific blood tests.
- Must have a new or worsening tumor seen on a scan within the last year or new symptoms related to the cancer.
- Must have at least one tumor that can be measured by scans.
- Must have finished any previous cancer treatments at least two weeks before starting this study.
- Must understand and agree to sign a consent form.
- Women of childbearing potential must have a negative pregnancy test before starting the study and agree to use contraception during and for 90 days after the study.
- Men must agree to use contraception during and for 90 days after the study if they are sexually active with women of childbearing potential.
Exclusion Criteria
- Cancer that is pressing on the spinal cord or could cause spinal cord compression, unless previously treated and stable.
- Active cancer spread to the brain or spinal fluid, unless previously treated and stable.
- Cannot take other cancer treatments or investigational drugs during the study.
- Cannot be on blood thinners that require regular monitoring.
- Cannot have uncontrolled illnesses like ongoing infections, heart failure, or unstable heart conditions.
- Cannot be pregnant or breastfeeding.
- Cannot have another active cancer that needs treatment, except for certain skin cancers or low-risk prostate cancer under surveillance.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Brigham and Women's Hospital | 02115 | Boston | Massachusetts |
| Dana Farber Cancer Institute | 02115 | Boston | Massachusetts |
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