Actively Recruiting
Clinical Study of [225Ac]Ac-FAPI-XT Injection in Patients With Advanced Solid Tumors
Led by Xiaorong Sun · Updated on 2025-08-21
20
Participants Needed
1
Research Sites
22 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, dosimetry, and preliminary effectiveness of [225Ac]Ac-FAPI-XT injection in patients with advanced solid tumors that express fibroblast activation protein (FAP). This early-phase clinical study focuses on patients whose cancer has progressed despite standard treatments or who lack effective standard options. The trial aims to better understand how this targeted therapy behaves in the body and its potential impact on tumor control. Participants will receive doses of [225Ac]Ac-FAPI-XT (also called XT117) given every 6 weeks. This is a single-arm study, meaning all participants receive the same investigational drug without a comparison group. The treatment targets FAP-positive tumors and involves monitoring for any side effects and measuring tumor response over time. The study treatment is administered under careful medical supervision to assess tolerance and possible benefits. Throughout the study, participants will undergo regular evaluations including scans, laboratory tests, and clinical assessments to monitor safety and tumor response. Researchers will track side effects and dose-limiting toxicities for up to two years following treatment. They will also measure outcomes such as overall response rate, duration of response, disease control rate, and progression-free survival. This comprehensive monitoring helps understand the treatment's profile and guides future development. Total participation duration varies based on individual response and study timelines.
CONDITIONS
Brief 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 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 FAP expression confirmed by FAP PET/CT
- Sufficient bone marrow capacity and organ function
You will not qualify if you...
- High intensity and large off-target uptake by FAP molecular imaging
- Received systemic antitumor therapy within 28 days before study treatment
- Used anti-tumor Chinese medicine within 2 weeks before study treatment
- Uncontrolled diabetes with fasting blood glucose > 2 times upper limit of normal
- Serious cardiovascular disease including:
- Grade II or higher congestive heart failure
- Unstable angina or heart attack within 6 months
- Severe arrhythmia within 6 months
- Poorly controlled hypertension above Grade 2
- QTc >450 ms (male) or 470 ms (female), congenital prolonged QT, or medications that prolong QT
- Serious thromboembolic disease within 6 months
- Major surgery within 4 weeks before study treatment
- History of severe gastrointestinal ulcers, perforations, or intestinal obstruction within 6 months
- Active infection requiring systemic treatment within 2 weeks
- 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
- Uncontrolled pleural, pericardial effusion, or ascites requiring repeated drainage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 6-week cycles until disease progression or discontinuation
Participants receive [225Ac]Ac-FAPI-XT injections at intervals of 6 weeks between each dose to evaluate safety, tolerability, and efficacy.
Visits every 6 weeks for each treatment dose
Duration - Up to 2 years after treatment
Participants are monitored for safety and treatment outcomes up to 2 years after treatment completion.
Periodic visits as scheduled for safety and efficacy assessments
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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