Actively Recruiting
A Clinical Study of [177Lu]Lu-XT117 Injection in Patients With Advanced Solid Tumors
Led by Ruimin Wang · Updated on 2024-01-18
20
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
R
Ruimin 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. Dose escalation will be conducted to determine the Dose Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD), Recommended Phase 2 Dose (RP2D), and to assess dosimetry characteristics.
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 or older
- Eastern Cooperative Oncology Group (ECOG) Performance status 0 to 1
- Confirmed malignant solid tumor by histopathology
- Measurable lesions based on RECIST 1.1
- Failed standard treatment due to progression or intolerance, or no standard treatment available
- Positive fibroblast activation protein (FAP) expression confirmed by FAP PET/CT
- Adequate bone marrow function 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
- Received systemic antitumor therapy within 28 days before study therapy; Chinese medicine with anti-tumor effects within 2 weeks before study therapy
- Uncontrolled diabetes with fasting blood glucose above twice the upper limit of normal
- Serious cardiovascular diseases including:
- Congestive heart failure above Grade II (NYHA)
- Unstable angina or myocardial infarction within 6 months before first study drug administration
- Severe arrhythmia within 6 months before first study drug administration
- Poorly controlled hypertension above Grade 2 despite treatment
- QTc interval over 450 ms (male) or 470 ms (female), congenital prolonged QT syndrome, or use of QT-prolonging drugs
- Serious thromboembolic disease within 6 months before first study drug administration
- Major surgery within 4 weeks before first study drug administration
- History of severe gastrointestinal ulcers, perforations, or intestinal obstruction within 6 months before first study drug administration
- Active infection requiring systemic treatment within 2 weeks before first study drug administration, 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 central nervous system tumor or symptomatic CNS metastases except:
- Asymptomatic brain metastases
- CNS lesions stable for at least 4 weeks after local treatment and off glucocorticoid or anticonvulsant therapy for 2 weeks before study drug administration
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Medical Center, Chinese PLA General Hospital
Beijing, China
Actively Recruiting
Research Team
A
Ang Yin
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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