A Clinical Study of [177Lu]Lu-XT117 Injection in Patients With Advanced Solid Tumors

Xinlu Wang

Status and phase

Enrolling

Phase 1

Conditions

Advanced Solid Tumor

Treatments

Drug: [177Lu]Lu-XT117

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06197139

XT-XTR017-1-01 V1.3

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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)
Primary central nervous system (CNS) tumor or symptomatic CNS metastasis, expect:
- Subjects with asymptomatic brain metastases;
- Subjects whose CNS lesions were stable for ≥4 weeks after local treatment and who stopped glucocorticoid or anticonvulsant therapy at least 2 weeks prior to study drug administration could be enrolled;
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage