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

X

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

Trial design

20 participants in 1 patient group

[177Lu]Lu-XT117 treatment
Experimental group
Treatment:
Drug: [177Lu]Lu-XT117

Trial contacts and locations

0

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Central trial contact

Ruiyue Zhao

Data sourced from clinicaltrials.gov

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