Actively Recruiting
A Clinical Study of [177Lu]Lu-XT117 Injection in Patients With Advanced Solid Tumors
Led by Xinlu Wang · Updated on 2024-01-09
20
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
X
Xinlu Wang
Lead Sponsor
S
Sinotau Pharmaceutical Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Study of [177Lu]Lu-XT117 Injection in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Histopathologically confirmed malignant solid tumor
- Measurable lesions based on RECIST 1.1
- Failed standard treatment due to progression or intolerance, or no standard treatment available
- Positive FAP expression confirmed by FAP PET/CT
- Adequate bone marrow capacity and organ function
You will not qualify if you...
- High intensity and large amounts of off-target uptake on FAP molecular imaging, assessed as unsuitable for [177Lu]Lu-XT117 therapy
- Prior systemic antitumor therapy within 28 days before the study treatment, including chemotherapy, radiotherapy, immunotherapy, investigational drugs, or Chinese medicine with anti-tumor effects within 2 weeks
- Uncontrolled diabetes with fasting blood glucose over 2 times the upper limit of normal
- Serious cardiovascular disease including: >Grade II congestive heart failure, unstable angina or myocardial infarction within 6 months, severe arrhythmia within 6 months, poorly controlled hypertension (except controlled Grade 2 with hypotensors), prolonged QT interval or congenital prolonged QT syndrome
- Serious thromboembolic disease within 6 months prior to treatment
- Major surgery within 4 weeks prior to treatment
- History of severe gastrointestinal ulcers, perforations, or intestinal obstruction within 6 months
- Active infection requiring systemic treatment within 2 weeks prior to treatment (except topical treatment)
- History of non-infectious interstitial lung disease or severe lung function impairment
- Other malignancies within 5 years before screening except clinically cured early stage cancers
- Primary CNS tumor or symptomatic CNS metastasis, except stable asymptomatic brain metastases off glucocorticoids or anticonvulsants for at least 2 weeks
- Uncontrolled pleural, pericardial effusion, or ascites requiring repeated drainage
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Actively Recruiting
Research Team
R
Ruiyue Zhao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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