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
ID06211647
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 Ruimin Wang · Updated on 2024-01-18
20
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the safety, tolerability, dosimetry, and early effects of [177Lu]Lu-XT117 injection in patients with advanced solid tumors that test positive for fibroblast activation protein (FAP). This Phase 1, single-center, single-arm study focuses on dose escalation to find the dose that limits toxicity, determine the highest tolerated dose, recommend a dose for further study, and understand dosimetry characteristics of the treatment. Participants will receive fixed dose levels of [177Lu]Lu-XT117, a radiopharmaceutical therapy combining a beta-emitting radioactive element with XT117. Doses will be given every 6 weeks. The study includes a dose escalation phase to evaluate safety and dosing limits. During the study, participants will be closely monitored for treatment-related side effects, dose-limiting toxicities, and the maximum tolerated dose up to 6 weeks after treatment. Researchers will assess response rates, disease control, progression-free and overall survival every 6 weeks for up to 2 years. Radiation dosimetry will be measured at multiple time points after the first dose. Participation may last up to 2 years with ongoing safety and efficacy evaluations.
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 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
- 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 on FAP imaging deemed unsuitable for [177Lu]Lu-XT117 therapy
- Received systemic antitumor therapy within 28 days before study therapy
- Used anti-tumor Chinese medicine within 2 weeks before study therapy
- Uncontrolled diabetes with fasting blood glucose over twice the upper limit
- Serious cardiovascular disease, including congestive heart failure > Grade II, recent unstable angina or myocardial infarction, severe arrhythmia, poorly controlled hypertension, or abnormal QT intervals
- Serious thromboembolic disease within 6 months before study drug
- Major surgery within 4 weeks before study drug
- History of severe gastrointestinal ulcers, perforations, or intestinal obstruction within 6 months
- Active infection requiring systemic treatment within 2 weeks before study drug
- History of non-infectious interstitial lung disease or severe lung impairment
- Other malignancies within 5 years except early-stage cured 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
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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 fixed doses of [177Lu]Lu-XT117 at intervals of 6 weeks between each dose as part of their treatment.
Visits every 6 weeks for dosing and assessments
Follow-up
Duration - Up to 6 months after the last administration
Participants are monitored for safety and treatment effects for up to 6 months after the last administration.
Approximately monthly visits during follow-up
Trial Site Locations
Total: 1 location
1
The First Medical Center, Chinese PLA General Hospital
Beijing, China
Actively Recruiting
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Research Team
A
Ang Yin
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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