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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cancer Hospital of Shandong First Medical University
  Jinan, Shandong, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SGT003 in people with advanced solid tumors

  This early-phase study tests SGT003 in adults with advanced solid tumors to see if it is safe and tolerable and to get a first look at how it behaves in the body and any early signs of benefit.

  Recruiting Phase 1/2 Beijing Sungen Biomedical Technology Co., Ltd · Beijing, Beijing Municipality · NCT07811037

• YSCH-01 Nebulized Therapy for Lung Metastases in NSCLC and Advanced Solid Tumors

  A first-in-human, early-phase study tests a nebulized therapy called YSCH-01 to see if it is safe and shows any signs of benefit for adults with NSCLC or other cancers that have spread to the lungs.

  Recruiting Early Phase 1 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing · NCT07793500

• Personalized neoantigen-pulsed dendritic cell injections for malignant solid tumors

  This study tests personalized dendritic cell injections, with or without immune checkpoint inhibitors, to see if they are safe and can help patients with advanced solid tumors.

  Recruiting ZSky Biotech Inc · Qinhuangdao, Hebei · NCT07752953

• STX-003 in advanced solid tumors given by IV, alone or with pembrolizumab

  This study tests STX-003, given by IV, to see if it is safe and potentially effective for patients with advanced solid tumors, either alone or with pembrolizumab.

  Recruiting at 4 sites Phase 1/2 Strand Therapeutics Inc. · Scottsdale, Arizona and 3 other locations · NCT07751042

• ARV-6723 alone or with pembrolizumab in adults with advanced solid tumors

  This study tests ARV-6723, by itself or with pembrolizumab, to see if it is safe and could help the immune system fight advanced solid tumors in adults.

  Recruiting at 4 sites Phase 1/2 Arvinas Inc. · New York, New York and 3 other locations · NCT07749586

• BG-85738 alone or with other anticancer drugs in RAS-mutant advanced or metastatic solid tumors

  This study tests BG-85738, alone or with other cancer drugs, in adults whose solid tumors have RAS mutations and have progressed.

  Recruiting at 3 sites Phase 1 BeOne Medicines · South Brisbane, Queensland and 2 other locations · NCT07746141

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.