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

Xinlu Wang1 site in 1 country20 target enrollmentJanuary 2024

ConditionsAdvanced Solid Tumor

Interventions[177Lu]Lu-XT117

Overview

Phase: Phase 1
Intervention: [177Lu]Lu-XT117
Conditions: Advanced Solid Tumor
Sponsor: Xinlu Wang
Enrollment: 20
Locations: 1
Primary Endpoint: Treatment emergent adverse events
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2024

End Date

December 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Xinlu Wang

Responsible Party

Sponsor Investigator

Principal Investigator

Xinlu Wang

Chief of Nuclear Medicine Department

The First Affiliated Hospital of Guangzhou Medical University

Eligibility Criteria

Inclusion Criteria

•≥18 years old
•Eastern Cooperative Oncology Group (ECOG) Performance status 0 to 1
•Confirmed as malignant solid tumor by histopathology
•Have measurable lesions based on RECIST 1.1
•Have failed standard treatment (disease progression or intolerance) or lack standard treatment
•Positive FAP expression confirmed by FAP PET/CT
•Sufficient bone marrow capacity and organ function

Exclusion Criteria

•High intensity and large amounts of off-target uptake by FAP molecular imaging, and were assessed as inappropriate for \[177Lu\]Lu-XT117 therapy by the investigators
•Previous systemic antitumor therapy (including prior chemotherapy, radiotherapy, immunotherapy, and other investigational drugs) ≤28 days before receiving study therapy; previous treatment with Chinese medicine with anti-tumor indications within 2 weeks before receiving study therapy
•Uncontrolled diabetes, with baseline fasting blood glucose \> 2×ULN
•Clinically significant serious cardiovascular disease, including but not limited to: a. \>Grade II congestive heart failure as per New York Heart Association (NYHA) ; b. Unstable angina pectoris or myocardial infarction within 6 months before the first administration of the study drug; c. Severe arrhythmia within 6 months prior to the first administration; d. Poorly controlled hypertension (patients who keep the blood pressure to ≤ Grade 2 hypertension \[CTCAE5.0\] with hypotensor are allowed for enrollment); e. QTc\>450 ms (male) or 470 ms (female), congenital prolonged QT syndrome, and use of medications that prolong QT
•Clinically serious thromboembolic disease within 6 months prior to the first administration of the study drug
•Major surgery within 4 weeks prior to the initial administration of the study drug
•History of severe gastrointestinal ulcers or perforations or history of intestinal obstruction within 6 months prior to the first administration
•Active infection requiring systemic treatment (oral or intravenous administration) within 2 weeks prior to the first administration, except for topical treatment
•History of non-infectious interstitial lung disease (ILD), such as idiopathic pulmonary fibrosis, idiopathic interstitial pneumonia, pneumoconiosis, and drug-related interstitial pneumonia, or severe impairment of lung function
•Had other malignancies within 5 years prior to screening (except clinically cured early stage malignancies)

Arms & Interventions

[177Lu]Lu-XT117 treatment

Intervention: [177Lu]Lu-XT117

Outcomes

Primary Outcomes

Treatment emergent adverse events

Time Frame: Until 6 months after the last administration

Incidence and severity of treatment emergent adverse events will be assessed as per CTCAE v5.0.

Secondary Outcomes

Disease Control Rate (DCR)(Every 6 weeks after first administration until disease progression or through study completion, assessed up to 2 years)
Overall Response Rate (ORR)(Every 6 weeks after first administration until disease progression or through study completion, assessed up to 2 years)
Duration of Response (DOR)(Every 6 weeks after first administration until disease progression or through study completion, assessed up to 2 years)
Radiation dosimetry of [177Lu]Lu-XT117 to whole body, lesions, organs, and selected regions of interest(1、4、24、48、72 and 168 hours after first administration)
Progression Free Survival (PFS)(Every 6 weeks after first administration until disease progression or death or through study completion, assessed up to 2 years)
Overall Survival (OS)(Every 6 weeks after first administration until death, assessed up to 2 years)