A Clinical Study of [225Ac]Ac-FAPI-XT(XT117) Injection in Patients With Advanced Solid Tumors

Not Applicable

Recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: 225Ac-FAPI-XT

• Registration Number: NCT07135128
• Lead Sponsor: Xiaorong Sun

Brief Summary

This is a single-center, single-arm clinical study to evaluate the safety, tolerability and preliminary efficacy of \[225Ac\]Ac-FAPI-XT injection in patients with FAP-positive advanced solid tumors.

Detailed Description

A Clinical Study to Evaluate the Safety, Tolerability, Dosimetry and Preliminary Efficacy of \[225Ac\]Ac-FAPI-XT Injection in FAP-positive Patients With Advanced Solid Tumors

Study Timeline

• Study Start: 2024-10-14
• Status Verified: 2025-08
• Study First Submitted: 2025-08-14
• Study First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Study First Posted: 2025-08-21
• Last Update Posted: 2025-08-21
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Exclusion Criteria

• High intensity and large amounts of off-target uptake by FAP molecular imaging 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
225Ac-FAPI-XT treatment	225Ac-FAPI-XT	-

Primary Outcome Measures

Name	Time	Method
Treatment emergent adverse events	Through study completion, assessed up to 2 years	adverse events Incidence and severity of treatment emergent adverse events will be assessed as per CTCAE v5.0.
Dose-limiting toxicity（DLT）	Through study completion, assessed up to 2 years	Incidence and severity of dose-limiting toxicities.

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	Through study completion, assessed up to 2 years.	Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR was based on RECIST 1.1 response for patients with measurable disease at baseline.(based on RECIST 1.1).
Duration of Response (DOR)	Through study completion, assessed up to 2 years.	Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented radiographic progression or death due to any cause .(based on RECIST 1.1).
Disease Control Rate (DCR)	Through study completion, assessed up to 2 years	Disease control rate (DCR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) according to RECIST v1.1.
Progression Free Survival (PFS)	Through study completion, assessed up to 2 years.	PFS is defined as the interval from the date of first dosing to the date of first demonstrated disease progression, or to the last date of known progression-free condition of the patient, or to the date of death (based on RECIST 1.1).

Trial Locations

Locations (1)

Cancer Hospital of Shandong First Medical University; 🇨🇳 Jinan, Shandong, China