Study on MK-2010 and Sacituzumab Tirumotecan for Treating Advanced Solid Tumors

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

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

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

FACILITYZIPCITYSTATE
START San Antonio ( Site 0220)78229San AntonioTexas

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