Clinical Evaluation of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression

Recruiting now · Phase 1

Conditions studied: Refractory Solid Tumor

In brief

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.

Key facts

Study ID

NCT06375564

Run by

The First Affiliated Hospital of Xiamen University

People needed

20

Starts

2024-06-12

Expected to finish

2026-12-30

Last updated by the study team

2025-08-08

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Eastern Cooperative Oncology Group Performance Status ≤ 3.
• 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.
• Hematologic parameters are defined as Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 50,000/mm3 Hemoglobin ≥ 8 g/dL.
• 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.

You may not qualify if…

• 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.
• 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.
• Has an additional active malignancy requiring therapy within the past 2 years.
• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
• Psychiatric illness/social situations that would interfere with compliance with study requirements
• Cannot undergo PET/CT scanning because of weight limits (350 lbs).
• INR>1.2; PTT>5 seconds above UNL.

Where it is running

• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (enrolling)

Full record on ClinicalTrials.gov

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