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

NCT06197139 | Recruiting Phase 1

• 1 other identifier: XT-XTR017-1-01 V1.3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Treatment emergent adverse events

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

  Until 6 months after the last administration

Secondary Outcomes (6)

• 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

• Disease Control Rate (DCR)

  Every 6 weeks after first administration until disease progression or through study completion, assessed up to 2 years

• 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

Study Arms (1)

[177Lu]Lu-XT117 treatment

EXPERIMENTAL

Drug: [177Lu]Lu-XT117

Interventions

[177Lu]Lu-XT117 DRUG

\[177Lu\]Lu-XT117 is a radiopharmaceutical therapy in which an beta emitter, Lu-177, is conjugated to XT117. Patients will receive \[177Lu\]Lu-XT117 administration at an interval of 6 weeks between each dose.

[177Lu]Lu-XT117 treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xinlu Wang: lead
• Sinotau Pharmaceutical Group: collaborator

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

RECRUITING

Related Publications (1)

• Liu H, Guo R, Zhang X, Ji H, Sun S, Sun S, Liu J, Yang Z, Wang R. Safety and efficacy of 177Lu-FAPI-XT radioligand therapy in patients with advanced sarcoma and other cancer entities: first-in-human, dose-escalation study. Eur J Nucl Med Mol Imaging. 2025 Oct 15. doi: 10.1007/s00259-025-07617-0. Online ahead of print.

  PMID: 41087606 DERIVED

Central Study Contacts

Ruiyue Zhao

CONTACT

(+86)18811477055; zhaory2014@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Nuclear Medicine Department

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 9, 2024
• Study Start: January 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 9, 2024

Record last verified: 2024-01

Locations

CN (1)