Exploratory Clinical Study of ¹⁷⁷Lu-CTR-FAPI in Patients With Metastatic Solid Tumors
An Exploratory Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of ¹⁷⁷Lu-CTR-FAPI in Patients With Metastatic Solid Tumors
This is a single-center, non-randomized, single-arm, open-label exploratory clinical study of ¹⁷⁷Lu-CTR-FAPI in patients with FAP-high expressing metastatic solid tumors, with a focus on breast cancer, sarcoma, and thyroid cancer.
The purpose of this study is to evaluate the safety and tolerability of ¹⁷⁷Lu-CTR-FAPI. The study will also assess its in vivo biodistribution, radiation absorbed dose in normal organs and target lesions, and preliminary clinical efficacy.
The main question this study aims to answer is whether ¹⁷⁷Lu-CTR-FAPI can be administered safely and shows sufficient tumor-targeting and preliminary therapeutic activity to support further clinical investigation in patients with FAP-high expressing metastatic solid tumors.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
This is an investigator-initiated, single-center, non-randomized, single-arm, open-label exploratory clinical trial of ¹⁷⁷Lu-CTR-FAPI in patients with FAP-high expressing metastatic solid tumors.
Participants will receive ¹⁷⁷Lu-CTR-FAPI by intravenous infusion. The planned standard activity is 200 mCi (7.4 GBq) ±10%, administered every 6±1 weeks for up to 4 cycles. Dose reduction to 100 mCi (3.7 GBq) may be performed according to predefined toxicity criteria.
During the first treatment cycle, participants will undergo intensive blood sampling and serial imaging to evaluate biodistribution and radiation dosimetry. Whole-body planar imaging and localized quantitative SPECT/CT will be performed at multiple time points from approximately 1 hour to 7-9 days after the initial administration. Regions of interest will be drawn for source organs and target lesions, and time-activity curves will be generated to estimate cumulative activity. Absorbed doses to normal organs and tumor lesions will be calculated using OLINDA/EXM software.
Safety will be monitored throughout the study by vital signs, physical examinations, laboratory tests, 12-lead electrocardiograms, and adverse event recording. Adverse events will be coded and graded according to CTCAE v5.0, with particular attention to hematologic, hepatic, and renal toxicities.
Tumor imaging evaluations will be performed according to the study schedule. Preliminary efficacy will be assessed using RECIST 1.1, including objective response rate and progression-free survival. Statistical analyses will be descriptive, and missing data will not be imputed.
Typ studie
Zápis (Aktuální)
Fáze
- Raná fáze 1
Kontakty a umístění
Studijní místa
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Gansu
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Lanzhou, Gansu, Čína, 730000
- The Second Hospital & Clinical Medical School, Lanzhou University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Pathological diagnosis confirmed metastatic solid tumors (breast cancer, sarcoma, and some thyroid cancers, etc.) that failed standard treatment or lacked standard treatment
- Age: 75 ≥ age ≥ 18 years
- ECOG score: 0 - 2
- 68Ga-CTR-FAPI PET/CT confirmed high expression of FAP in the tumor (more than 50% of the lesions with SUVmax ≥ 10)
- The FAP immunohistochemical score of tumor cells is ≥ 2 (except for thyroid cancer)
- There is at least one measurable lesion (RECIST 1.1)
- Organ/marrow functions meet the specified thresholds, and there are no severe electrocardiogram abnormalities (QTcF ≤ 470ms)
Exclusion Criteria:
- There is brain metastasis or other central nervous system lesions.
- The expected survival period is less than 6 months.
- Within 4 weeks before administration, the patient has received chemotherapy, targeted therapy, immunotherapy, or other anti-tumor treatments or investigational drugs.
- The patient has previously received other systemic radionuclide therapy (excluding 131I treatment for thyroid cancer).
- There is uncontrolled pleural effusion, ascites, severe cardiovascular or cerebrovascular diseases, or infection.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Pacienti s pokročilými metastazujícími solidními tumory
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a novel covalent targeted radioligand (CTR), ¹⁷⁷Lu-CTR-FAPI, utilizing a sulfur(VI) fluoride exchange (SuFEx) click chemistry-based strategy
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events
Časové okno: From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI through 6 weeks after the last administration
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Number of participants with treatment-emergent adverse events, serious adverse events, and adverse events leading to treatment discontinuation.
Adverse events will be coded and graded according to the Common Terminology Criteria for Adverse Events version 5.0.
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From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI through 6 weeks after the last administration
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Number of Participants With Abnormal Vital Signs
Časové okno: From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI through 6 weeks after the last administration
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Number of participants with clinically significant abnormal vital signs, including systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, body temperature, and oxygen saturation, as determined by the investigator.
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From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI through 6 weeks after the last administration
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Number of Participants With Abnormal Laboratory Test Results
Časové okno: From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI through 6 weeks after the last administration
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Number of participants with clinically significant abnormal laboratory test results, including complete blood count, liver function tests, renal function tests, and serum electrolytes, graded according to the Common Terminology Criteria for Adverse Events version 5.0 when applicable.
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From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI through 6 weeks after the last administration
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Objective Response Rate
Časové okno: Every 8 weeks from baseline until disease progression, initiation of new anticancer therapy, withdrawal, death, or study completion, up to 12 months
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Objective response rate is defined as the proportion of participants with a best overall response of complete response or partial response according to RECIST version 1.1.
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Every 8 weeks from baseline until disease progression, initiation of new anticancer therapy, withdrawal, death, or study completion, up to 12 months
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Progression-Free Survival
Časové okno: From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI until disease progression or death, up to 12 months
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Progression-free survival is defined as the time from the first administration of [¹⁷⁷Lu]Lu-CTR-FAPI to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
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From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI until disease progression or death, up to 12 months
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Radiation dosimetry
Časové okno: It should be measured within 1 hour to 7 to 9 days after the first administration of the drug.
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Through whole-body planar imaging, local SPECT/CT quantitative tomographic imaging combined with blood sample determination, the radiation absorption doses of normal organs and target lesions were calculated using the OLINDA/EXM software.
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It should be measured within 1 hour to 7 to 9 days after the first administration of the drug.
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
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- 2024A-1337
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Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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