An Open-Label, Non-Randomized, Single-Center, Investigator-Initiated Trial to Determine the Effectiveness of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression

XMYY-2020KY067-05

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.

2024-05-01

2025-12-30

2026-12-30

Recruiting

Early phase I

20

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 (ULN) Total bilirubin ≤ 3 times ULN Creatinine ≤ 3 times ULN Able to remain motionless for up to 30-60 minutes per scan. Exclusion Criteria: 1. Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA). 2. Participants with Class 3 or 4 NYHA Congestive Heart Failure. 3. Clinically significant bleeding within two weeks before trial entry (e.g. gastrointestinal bleeding, intracranial bleeding). 4. Pregnant or lactating women. 5. Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e. larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days before study day 1 or anticipated surgery within the subsequent 6 weeks. 6. Has an additional active malignancy requiring therapy within the past 2 years. 7. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. 8. Psychiatric illness/social situations that would interfere with compliance with study requirements 9. Cannot undergo PET/CT scanning because of weight limits (350 lbs). 10. INR\>1.2; PTT\>5 seconds above UNL.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2024-04-23