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This is an open-label, non-controlled, non-randomized study to assess the therapeutic efficacy of 177Lu-AB-3PRGD2 in patients with various solid tumors who will undergo radioligand therapy using 177Lu-AB-3PRGD.
Integrin αvβ3 is highly expressed in some tumor cells and neovascularization, which is an ideal target for diagnosis and treatment of solid tumors. 177Lu-AB-3PRGD2, is a kind of new drug based on independent research and development in China, providing an effective target for the treatment of tumors. All patients underwent whole-body 68Ga-RGD PET/CT for selection and accepted intravenous injection with a fixed dose of 2.96 GBq (80 mCi) of 177Lu-AB-3PRGD2 within one week. Treatment is planned for up to 4 cycles, and the time interval between cycles is 6 weeks. The primary endpoint assessed the preliminary treatment efficacy of 177Lu-AB-3PRGD2 used for radioligand therapy in patients with various advanced tumors. The secondary endpoint evaluates the safety of 177Lu-AB-3PRGD2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 177Lu-AB-3PRGD2 | Experimental | 177Lu-AB-3PRGD2 A maximum of 4 cycles of 80 mCi (2.96 GBq) 177Lu-AB-3PRGD2, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, every 6 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 177Lu-AB-3PRGD2 radioligand therapy | Drug | Radioligand therapy using 177Lu-AB-3PRGD2 80 mCi (2.96 GBq) will be performed 6-weekly. A maximum of 4 cycles will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | 68Ga-RGD will be performed for efficacy evaluation by RECIST 1.1. Particularly, 68Ga-RGD will be performed at baseline, and 6 weeks after two treatment cycles. | At the end of Cycle 4 (each cycle is 42 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-related adverse events (safety and tolerability) | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. Dose-limiting toxicity was defined as any 177Lu-AB-3PRGD2-related AE ≥ grade 3 (G3). For Hemoglobin < 8.0 g/dL; < 4.9 mmol/L; < 80 g/L; Need blood transfusion heal. Severe hypocytosis or with this age group The total number of normal cells was reduced >50% and ≤75%. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haojun Chen, MD, PhD | Contact | +8618659285282 | leochen0821@foxmail.com | |
| Hao Fu | Contact | +8615959230059 | fuhaonuclear@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Haojun Chen, MD, PhD | The First Affiliated Hospital of Xiamen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | Fujian | 361003 | China |
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| At the end of Cycle 4 (each cycle is 42 days) |