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New treatment option for Advanced Solid Tumor
Official title A Clinical Study of [177Lu]Lu-XT117 Injection in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06197139
What this study is testing
What is [177Lu]Lu-XT117?
[177Lu]Lu-XT117 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥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
You likely can't join if
- High intensity and large amounts of off-target uptake by FAP molecular imaging, and were assessed as inappropriate for [177Lu]Lu-XT117 therapy by the...
- Previous systemic antitumor therapy (including prior chemotherapy, radiotherapy, immunotherapy, and other investigational drugs) ≤28 days before...
- 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...
- 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
See the full eligibility 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 Key
- High intensity and large amounts of off-target uptake 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...
- 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...
- 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...
- 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:
- people with asymptomatic brain metastases;
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.