Study Evaluating Treatment of Sacituzumab-govitecan for Patients With Metastatic Esophagogastric … (NCT06123468) | Clinical Trial Compass
CompletedPhase 1/2
Study Evaluating Treatment of Sacituzumab-govitecan for Patients With Metastatic Esophagogastric Adenocarcinoma
Austria, Germany58 participantsStarted 2024-04-17
Plain-language summary
The study is a open-label, single-arm, multicenter, phase Ib/II trial assessing the efficacy of sacituzumab-govitecan for metastatic esophagogastric adenocarcinoma
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient\* has given written informed consent.
✓. Patient is, in the investigator's judgement, willing and able to comply with the study protocol.
✓. Patient is ≥ 18 years of age at time of signing the written informed consent.
✓. Patient has been diagnosed with histologically confirmed metastatic (stage IV) esophagogastric adenocarcinoma.
✓. Patient has received at least one prior therapy containing platinum compound and a fluoropyrimidine, potentially combined with immunotherapy, in the metastatic setting. Neoadjuvant/adjuvant platinum-fluoropyrimidine treatment is counted as first-line therapy if disease progression occurred within 6 months after completion of treatment.
✓. Patient has an ECOG performance status ≤ 1.
✓. Patient must have an estimated life expectancy of at least 12 weeks.
✓. Patient has at least one measurable lesion on radiographic imaging as defined by RECIST v1.1.
Exclusion criteria
✕. Patient has known hypersensitivity to any component of the Sacituzumab-govitecan formulation as well as a known history of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies or fusion protein.
✕. Patient has received previously topoisomerase 1 inhibitors such as irinotecan, or nal-irinotecan
✕. Patient has an active second malignancy. Note: patients with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or patients with surgically cured tumors with low risk of recurrence (e.g., non-melanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll
What they're measuring
1
Overall response rate
Timeframe: up to 12 months
Trial details
NCT IDNCT06123468
SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
✕. Patients with known, untreated and active (not stable within the last 4 weeks or symptomatic) brain metastases and patients with leptomeningeal disease.
✕. Patient meets any of the following criteria for cardiac disease:
✕. Myocardial infarction or unstable angina pectoris within 6 months prior to initiation of study treatment
✕. History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular bock, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation
✕. New York Heart Associated (NYHA) class III or greater congestive heart failure or left ventricular ejection fraction (LVEF) of \< 40% if echocardiography has been performed