Evaluating [177Lu]Lu-XT117 Injection for Advanced Solid Tumors

A Clinical Study to Evaluate the Safety, Tolerability, Dosimetry and Preliminary Efficacy of [177Lu]Lu-XT117 Injection in FAP-positive Patients With Advanced Solid Tumors

This study is testing a new injection for people with advanced solid tumors that haven't responded to other treatments to see if it's safe and effective.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chinese PLA General Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT06211647 on ClinicalTrials.gov

What this trial studies

This clinical study focuses on assessing the safety, tolerability, and preliminary efficacy of [177Lu]Lu-XT117 injection in patients with advanced solid tumors that express FAP. It is a single-center, single-arm study that will involve dose escalation to identify the maximum tolerated dose and evaluate dosimetry characteristics. Patients who have not responded to standard treatments will be included, and the study aims to gather important data on the drug's effects and safety profile.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with FAP-positive advanced solid tumors who have failed standard treatments.

Not a fit: Patients with uncontrolled diabetes or significant off-target uptake detected by FAP imaging may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that have limited treatment alternatives.

How similar studies have performed: While this approach is novel, similar studies targeting FAP-positive tumors have shown promise, indicating potential for success.

Eligibility criteria

Key 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

Key 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

Where this trial is running

Beijing

• The First Medical Center, Chinese PLA General Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Ruimin Wang — The First Medical Center, Chinese PLA General Hospital
• Study coordinator: Ang Yin

Conditions Advanced Solid Tumor