225Ac-labeled FAPI-XT (XT117) injection for FAP-positive advanced solid tumors

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

This treatment tests a targeted radioactive drug called [225Ac]Ac-FAPI-XT in adults with FAP-positive advanced solid tumors to see if it is safe and can slow or shrink tumors.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shandong Cancer Hospital and Institute (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT07135128 on ClinicalTrials.gov

What this trial studies

This is a single-center, single-arm Phase 1 effort administering the alpha-emitting radiopharmaceutical [225Ac]Ac-FAPI-XT to adults whose advanced solid tumors show FAP expression. The study will measure safety, tolerability, organ dosimetry, and preliminary signals of antitumor activity using RECIST 1.1 criteria. Eligible patients must be ≥18 years with ECOG 0–1, measurable disease, prior standard therapy failure or lack of standard options, and adequate organ and marrow function confirmed by labs. Key exclusions include high off-target uptake on FAP imaging, recent systemic anticancer therapy within 28 days, uncontrolled diabetes, and significant cardiovascular disease.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with FAP-positive measurable advanced solid tumors, ECOG performance 0–1, adequate organ and bone marrow function, and who have exhausted or lack standard treatment options.

Not a fit: Patients without FAP expression, those with high off-target uptake on FAP imaging, recent systemic therapy within 28 days, uncontrolled diabetes, significant cardiac disease, or poor performance status are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could provide a new targeted radiopharmaceutical option to shrink tumors or slow progression in patients with FAP-positive advanced solid tumors.

How similar studies have performed: FAP-targeting imaging agents are well established and some early-phase therapeutic FAPI studies have shown promising signals, but alpha-emitter FAPI therapies remain experimental with limited clinical outcome data.

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 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

Where this trial is running

Jinan, Shandong

• Cancer Hospital of Shandong First Medical University — Jinan, Shandong, China (RECRUITING)

Conditions: Advanced Solid Tumor