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This is a single-center, single-arm clinical study to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [177Lu]Lu-XT117 injection in patients with FAP-positive advanced solid tumors.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Key Exclusion Criteria:
High intensity and large amounts of off-target uptake by FAP molecular imaging, and were assessed as inappropriate for [177Lu]Lu-XT117 therapy by the investigators
Previous systemic antitumor therapy (including prior chemotherapy, radiotherapy, immunotherapy, and other investigational drugs) ≤28 days before receiving study therapy; previous treatment with Chinese medicine with anti-tumor indications within 2 weeks before receiving study therapy
Uncontrolled diabetes, with baseline fasting blood glucose > 2×ULN
Clinically significant serious cardiovascular disease, including but not limited to: a. >Grade II congestive heart failure as per New York Heart Association (NYHA) ; b. Unstable angina pectoris or myocardial infarction within 6 months before the first administration of the study drug; c. Severe arrhythmia within 6 months prior to the first administration; d. Poorly controlled hypertension (patients who keep the blood pressure to ≤ Grade 2 hypertension [CTCAE5.0] with hypotensor are allowed for enrollment); e. QTc>450 ms (male) or 470 ms (female), congenital prolonged QT syndrome, and use of medications that prolong QT
Clinically serious thromboembolic disease within 6 months prior to the first administration of the study drug
Major surgery within 4 weeks prior to the initial administration of the study drug
History of severe gastrointestinal ulcers or perforations or history of intestinal obstruction within 6 months prior to the first administration
Active infection requiring systemic treatment (oral or intravenous administration) within 2 weeks prior to the first administration, except for topical treatment
History of non-infectious interstitial lung disease (ILD), such as idiopathic pulmonary fibrosis, idiopathic interstitial pneumonia, pneumoconiosis, and drug-related interstitial pneumonia, or severe impairment of lung function
Had other malignancies within 5 years prior to screening (except clinically cured early stage malignancies)
Primary central nervous system (CNS) tumor or symptomatic CNS metastasis, expect:
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
Primary purpose
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Interventional model
Masking
20 participants in 1 patient group
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Central trial contact
Ruiyue Zhao
Data sourced from clinicaltrials.gov
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