Clinical Evaluation of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Ability to understand and willingness to sign a written informed consent document. 2. Age 18 and older. 3. 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). 4. Progressive disease after multiple-lines treatment. 5. Eastern Cooperative Oncology Group Performance Status ≤ 3. 6. Participant must have completed prior therapy at least 2 weeks (washout period) before 68Ga-RGD PET/CT scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved below Grade 2 or baseline. Completion of entry into 68Ga-RGD study and completion of the scan. 7. Hematologic parameters are defined as Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 50,000/mm3 Hemoglobin ≥ 8 g/dL. 8. Blood chemistry levels defined as AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (UL