Status:
RECRUITING
A Clinical Study of [177Lu]Lu-XT117 Injection in Patients With Advanced Solid Tumors
Lead Sponsor:
Ruimin Wang
Collaborating Sponsors:
Sinotau Pharmaceutical Group
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Key
- ≥18 years old
- Eastern Cooperative Oncology Group (ECOG) Performance status 0 to 1
- Confirmed as malignant solid tumor by histopathology
- Have measurable lesions based on RECIST 1.1
- Have failed standard treatment (disease progression or intolerance) or lack of standard treatment
- Positive FAP expression confirmed by FAP PET/CT
- Sufficient bone marrow capacity and organ function
- Key
Exclusion
- High intensity and large amounts of off-target uptake detected 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 hypotensors are acceptable 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 first administration
- 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:
- Subjects with asymptomatic brain metastases;
- Subjects whose CNS lesions were stable for ≥4 weeks after local treatment and who stopped glucocorticoid or anticonvulsant therapy at least 2 weeks prior to study drug administration could be enrolled;
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06211647
Start Date
January 1 2024
End Date
December 1 2026
Last Update
January 18 2024
Active Locations (1)
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1
The First Medical Center, Chinese PLA General Hospital
Beijing, China