Actively Recruiting
A Clinical Study of [225Ac]Ac-FAPI-XT(XT117) Injection in Patients With Advanced Solid Tumors
Led by Xiaorong Sun · Updated on 2025-08-21
20
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, single-arm clinical study to evaluate the safety, tolerability and preliminary efficacy of \[225Ac\]Ac-FAPI-XT injection in patients with FAP-positive advanced solid tumors.
CONDITIONS
Official Title
A Clinical Study of [225Ac]Ac-FAPI-XT(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 of 0 to 1
- Confirmed malignant solid tumor by histopathology
- Have measurable lesions based on RECIST 1.1
- Have failed standard treatment due to disease progression or intolerance, or lack standard treatment options
- Positive FAP expression confirmed by FAP PET/CT
- Sufficient bone marrow function and organ function
You will not qualify if you...
- High intensity and large amounts of off-target uptake by FAP molecular imaging
- Previous systemic antitumor therapy within 28 days before study therapy, including chemotherapy, radiotherapy, immunotherapy, or investigational drugs
- Previous treatment with Chinese medicine with anti-tumor effects within 2 weeks before study therapy
- Uncontrolled diabetes with fasting blood glucose more than twice the upper limit of normal
- Serious cardiovascular disease such as: a. Greater than Grade II congestive heart failure b. Unstable angina or myocardial infarction within 6 months c. Severe arrhythmia within 6 months d. Poorly controlled hypertension above Grade 2 (controlled hypertension allowed) e. Prolonged QT interval or use of medications that prolong QT
- Clinically serious thromboembolic disease within 6 months
- Major surgery within 4 weeks prior to initial administration
- History of severe gastrointestinal ulcers, perforations, or intestinal obstruction within 6 months
- Active infection requiring systemic treatment within 2 weeks, except topical treatment
- History of non-infectious interstitial lung disease or severe lung impairment
- Other malignancies within 5 years except clinically cured early stage cancers
- Primary CNS tumor or symptomatic CNS metastasis, except stable asymptomatic brain metastases meeting criteria
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 100023
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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