Study on MK-2010 and Sacituzumab Tirumotecan for Treating Advanced Solid Tumors
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT07785609
This clinical trial is testing a new treatment combination of MK-2010 and sacituzumab tirumotecan (sac-TMT) to see if it can help the immune system fight advanced solid tumors that have spread or are difficult to treat with surgery or radiation.
Patient Parameters
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Program Overview
Researchers are exploring a new treatment for advanced solid tumors, which are cancers found in organs and tissues. These tumors may have spread or not responded to previous treatments. The trial is testing MK-2010, a drug designed to help the immune system fight cancer, in combination with sacituzumab tirumotecan (sac-TMT), an antibody-drug conjugate that targets and destroys cancer cells. The study aims to determine if this combination is safe, well-tolerated, and effective in shrinking or eliminating tumors.
Eligibility Criteria
Inclusion Criteria
- Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- If living with HIV, the virus must be well-controlled with medication.
- If positive for hepatitis B, the virus must be undetectable and treated for at least 4 weeks.
- If previously infected with hepatitis C, the virus must be undetectable.
- Must have adequate organ function.
Exclusion Criteria
- Have received any cancer treatment within 4 weeks or 5 half-lives before starting the study.
- Have had local cancer treatments within 2 weeks before the study or have ongoing side effects from such treatments.
- Are currently taking blood thinners.
- Stopped previous immunotherapy due to severe side effects.
- Have an immune system deficiency or are on long-term steroid or immunosuppressive therapy.
- Have another progressing cancer or one that needed treatment in the last 2 years.
- Have cancer that has spread to the brain or spinal cord.
- Have an active autoimmune disease needing treatment in the last 2 years.
- Have a history of lung inflammation needing steroids or current lung issues.
- Have ongoing mouth sores or inflammation.
- Have HIV with a history of certain related diseases.
- Have severe liver conditions or complications.
- Have a history of certain brain conditions or seizures.
- Have severe eye conditions affecting healing.
- Have had a stem cell or organ transplant.
- Have not fully recovered from major surgery or have surgical complications.
- Have had significant bleeding in the last 4 weeks.
- Have had serious bleeding events in the last 3 months.
- Have fluid buildup around the lungs, heart, or abdomen needing drainage.
- Have a history of heart inflammation or disease.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| START San Antonio ( Site 0220) | 78229 | San Antonio | Texas |
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