NCT06211647 A Clinical Study of [177Lu]Lu-XT117 Injection in Patients With Advanced Solid Tumors
| NCT ID | NCT06211647 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Ruimin Wang |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Ruimin Wang
PRINCIPAL INVESTIGATOR
The First Medical Center, Chinese PLA General Hospital
Frequently Asked Questions
Who can join the NCT06211647 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06211647 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06211647 currently recruiting?
Yes, NCT06211647 is actively recruiting participants. Contact the research team at ang.yin@sinotau.com for enrollment information.
Where is the NCT06211647 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06211647 clinical trial?
NCT06211647 is sponsored by Ruimin Wang. The principal investigator is Ruimin Wang at The First Medical Center, Chinese PLA General Hospital. The trial plans to enroll 20 participants.