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

NCT ID: NCT06211647

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2026-12-31

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. Dose escalation will be conducted to determine the Dose Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD), Recommended Phase 2 Dose (RP2D), and to assess dosimetry characteristics.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

[177Lu]Lu-XT117 dose escalation

Group Type: EXPERIMENTAL

[177Lu]Lu-XT117

Intervention Type: 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 fixed dose levels at an interval of 6 weeks between each dose.

Interventions

[177Lu]Lu-XT117

\[177Lu\]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 fixed dose levels at an interval of 6 weeks between each dose.

Intervention Type: DRUG

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 of 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 detected 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 hypotensors are acceptable 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 first administration
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sinotau Pharmaceutical Group

INDUSTRY

Sponsor Role: collaborator

Ruimin Wang

OTHER

Sponsor Role: lead

Responsible Party

Ruimin Wang

Chief of Nuclear Medicine Department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ruimin Wang

Role: PRINCIPAL_INVESTIGATOR

The First Medical Center, Chinese PLA General Hospital

Locations

The First Medical Center, Chinese PLA General Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Ang Yin

Role: CONTACT

ang.yin@sinotau.com

(+86)010-52805808

Facility Contacts

Ang Yin

Role: primary

ang.yin@sinotau.com

(+86)010-52805808

References

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.

Reference Type: DERIVED

PMID: 41087606 (View on PubMed)

Other Identifiers

XT-XTR017-1-01 V1.1

Identifier Type: -

Identifier Source: org_study_id