Safety and efficacy of 177Lu-FAPI-XT radioligand therapy in patients with advanced sarcoma and other cancer entities: first-in-human, dose-escalation study.
Honghong Liu, Rui Guo, Xiaojun Zhang...
https://pubmed.ncbi.nlm.nih.gov/41087606Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID06197139
A Clinical Study to Evaluate the Safety, Tolerability, Dosimetry and Preliminary Efficacy of [177Lu]Lu-XT117 Injection in FAP-positive Patients With Advanced Solid Tumors
Led by Xinlu Wang · Updated on 2024-01-09
20
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the safety, tolerability, dosimetry, and preliminary efficacy of [177Lu]Lu-XT117 injection in patients with advanced solid tumors that express fibroblast activation protein (FAP). This is a Phase 1, single-center, single-arm clinical study focusing on patients who have FAP-positive tumors and have failed or lack standard treatments. Participants will receive doses of [177Lu]Lu-XT117, a radiopharmaceutical therapy combining the beta emitter Lu-177 with XT117. The treatment is administered every 6 weeks. The study monitors radiation dosimetry at specific time points after the first dose and continues evaluations throughout the treatment period. During the study, participants will be regularly assessed for treatment-emergent adverse events for up to 6 months after the last dose. Researchers will also evaluate tumor response and survival outcomes every 6 weeks for up to 2 years, including overall response rate, duration of response, disease control rate, progression-free survival, and overall survival. Radiation exposure to the whole body and organs is measured at multiple intervals after treatment to understand distribution and safety.
CONDITIONS
Brief Title
A Clinical Study of [177Lu]Lu-XT117 Injection in Patients With Advanced Solid Tumors
Who Can Participate
Age: 18Years +
All Genders
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
- Measurable lesions based on RECIST 1.1 criteria
- Have failed standard treatment or lack standard treatment options
- Positive fibroblast activation protein (FAP) expression confirmed by FAP PET/CT
- Sufficient bone marrow capacity and organ function
You will not qualify if you...
- High intensity and extensive off-target uptake in FAP imaging, deemed unsuitable for [177Lu]Lu-XT117 therapy
- Systemic antitumor therapy within 28 days before study treatment; Chinese medicine with anti-tumor effects within 2 weeks before study treatment
- Uncontrolled diabetes with fasting blood glucose greater than twice the upper limit of normal
- Serious cardiovascular diseases including Grade II or higher heart failure, unstable angina or recent myocardial infarction, severe arrhythmia, poorly controlled hypertension except controlled Grade 2 hypertension, prolonged QT interval, and related medication use
- Serious thromboembolic disease within 6 months before treatment
- Major surgery within 4 weeks before treatment
- History of severe gastrointestinal ulcers, perforations, or intestinal obstruction within 6 months
- Active infection requiring systemic treatment within 2 weeks before treatment
- History of non-infectious interstitial lung disease or severe lung impairment
- Other malignancies within 5 years prior to screening except clinically cured early stage cancers
- Primary central nervous system tumor or symptomatic CNS metastasis except stable or asymptomatic brain metastases
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Repeated 6-week cycles until disease progression or discontinuation
Participants receive [177Lu]Lu-XT117 radiopharmaceutical therapy administered every 6 weeks.
Visits every 6 weeks for treatment administration and assessments
Follow-up
Duration - Up to 6 months after last treatment
Participants are monitored for treatment emergent adverse events and overall survival for up to 6 months after the last administration.
Visits as needed for safety monitoring
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Actively Recruiting
Loading map...
Research Team
R
Ruiyue Zhao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here