Study on Sacituzumab Tirumotecan for Advanced/Metastatic Gastroesophageal Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06356311

This clinical trial is testing a new drug, sacituzumab tirumotecan, to see if it is safer and more effective than the usual treatments chosen by doctors for patients with advanced or metastatic gastroesophageal cancer.

Patient Parameters

Program Overview

The purpose of this study is to compare the safety and effectiveness of a new drug called sacituzumab tirumotecan with the standard treatments chosen by doctors for patients with advanced or metastatic gastroesophageal adenocarcinoma. Researchers hope that sacituzumab tirumotecan will help patients live longer than the current treatment options.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or metastatic gastroesophageal cancer that cannot be removed by surgery.
  • Have already tried at least two different chemotherapy or immunotherapy treatments without success.
  • Eligible regardless of HER2 status, but if HER2 positive, must have tried trastuzumab if available.
  • Have good organ function as shown by medical tests.
  • Provide a tumor sample to check for a specific protein called TROP2.
  • Any side effects from previous cancer treatments must have improved to a mild level or returned to normal, except for hair loss and skin changes.
  • Have cancer that can be measured by scans.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Be able to swallow pills if needed.
  • If HIV positive, must have the virus well-controlled with medication.
  • If hepatitis B positive, must be on antiviral treatment with undetectable virus levels.
  • If previously infected with hepatitis C, must have undetectable virus levels.

Exclusion Criteria

  • Have severe eye conditions that affect healing.
  • Have moderate to severe nerve damage.
  • Have active inflammatory bowel disease or a history of it.
  • Have serious heart or blood vessel problems within the last 6 months.
  • Have fluid buildup in the body that needs treatment within the last 2 weeks.
  • Have previously received treatments targeting TROP2 or certain chemotherapy drugs.
  • Have had cancer treatment or radiation therapy within the last 2 weeks.
  • Have received a live vaccine within the last 30 days.
  • Are taking certain medications that affect liver enzymes and cannot stop them.
  • Have participated in another clinical trial within the last 4 weeks.
  • Have another active cancer that needed treatment in the last 3 years.
  • Have cancer that has spread to the brain or spinal cord.
  • Have an active infection needing treatment.
  • Have HIV with a history of certain related diseases.
  • Have active hepatitis B and C infections.
  • Have had major surgery or injury within the last 4 weeks.
  • Have severe allergies to the study drug or similar treatments.

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