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.
Ability to understand and willingness to sign a written informed consent document.
Age 18 and older.
Confirmed unresectable or metastatic refractory cancer with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion > 1 cm or lymph node > 1.5 cm in short axis).
Progressive disease after multiple-lines treatment.
Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA).
Participants with Class 3 or 4 NYHA Congestive Heart Failure.
Clinically significant bleeding within two weeks before trial entry (e.g. gastrointestinal bleeding, intracranial bleeding).
Pregnant or lactating women.
Single group
177Lu-AB-3PRGD2 radioligand therapy
DrugRadioligand therapy using 177Lu-AB-3PRGD2 80 mCi (2.96 GBq) will be performed 6-weekly. A maximum of 4 cycles will be administered.
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.
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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