Clinical Study of 177Lu-JH040182 in Patients With FAP-Positive Malignancies
First-in-Human Safety and Dosimetry Study of ¹⁷⁷Lu-FAPI in Patients With FAP-Positive Malignancies
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Cancer-associated fibroblasts (CAFs) constitute a critical component of the tumor microenvironment and are widely distributed in the stroma of various malignancies. Fibroblast activation protein (FAP), a specific biomarker of CAFs, is overexpressed in more than 90% of malignant tumors but exhibits limited expression in normal tissues, rendering it an ideal target for the diagnosis and treatment of multiple cancers. To date, a variety of FAP-targeted radiopharmaceuticals have been developed for radionuclide therapy, such as 177Lu-FAPI-46 and 177Lu-FAP-2286. These agents have demonstrated potent anti-tumor efficacy and a favorable toxicity profile in oncological treatment. The novel radiopharmaceutical 177Lu-JH040182 also exhibits excellent in vitro and in vivo stability. Preclinical investigations have validated its high binding affinity, favorable safety profile and outstanding tumor selectivity, enabling specific accumulation within neoplastic tissues.
This study aimed to evaluate the dosimetric effects, toxicities and therapeutic efficacy of 177Lu-JH040182 in patients with advanced metastatic cancers who failed all prior therapeutic regimens without meaningful clinical improvement. Eligible patients first underwent 68Ga-FAPI PET/CT to confirm FAP-positive lesions (defined as >50% of lesions with an SUVmax exceeding 10). Upon confirmation, patients received intravenous administration of 177Lu-JH040182 at a radioactivity dose ranging from 5.55 to 7.40 GBq. Serial SPECT imaging was subsequently performed at multiple time points for each subject, and the absorbed doses to tumor lesions and normal physiological organs were quantified using the Hermes system software.
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Fujian
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Fuzhou, Fujian, Cina, 350005
- Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- progressive advanced metastatic tumors
- tumors with high FAP expression confirmed on 68Ga-FAPI PET/CT (defined as a maximum standardized uptake value ≥10 in more than 50% of tumor lesions)
- an Eastern Cooperative Oncology Group performance status of 0-2
Exclusion Criteria:
- pregnant or lactating women
- received other radionuclide therapy in the past 6 months
- received chemotherapy, radiotherapy and other anti-tumor treatments in the past 28 days
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Intravenous administration of 177Lu-JH040182
It is planned to recruit 3 subjects with FAP-positive tumors for administration of 177Lu-JH040182 at a dose ranging from 5.55 to 7.50 GBq.
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Subjects will receive intravenous administration of 177Lu-JH040182 at an activity of approximately 5.55-7.50
GBq.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Toxic and side effect
Lasso di tempo: From enrollment till 30 days safety follow-up, assessed up to 50 months (estimated final OS analysis)
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The distribution of adverse events (AE) will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
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From enrollment till 30 days safety follow-up, assessed up to 50 months (estimated final OS analysis)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Dosimetry of normal organs and tumors
Lasso di tempo: through study completion, an average of 4 weeks
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After the initial administration of 177Lu-JH040182, SPECT images will be acquired at multiple time points.
The Hermes system will be used to calculate and record the absorbed doses of normal organs and tumors.
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through study completion, an average of 4 weeks
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Weibing Miao, MD, the First Affiliated Hospital, Fujian Medical University
Studiare le date dei record
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- FirstAHFujian-177Lu-JH040182
Informazioni su farmaci e dispositivi, documenti di studio
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