Overview

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

Status:
Recruiting
Trial end date:
2026-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Xinlu Wang
Collaborator:
Sinotau Pharmaceutical Group
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