Clinical Evaluation of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression
NCT ID: NCT06375564
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2024-06-12
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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177Lu-AB-3PRGD2
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
177Lu-AB-3PRGD2 radioligand therapy
Radioligand therapy using 177Lu-AB-3PRGD2 80 mCi (2.96 GBq) will be performed 6-weekly. A maximum of 4 cycles will be administered.
Interventions
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177Lu-AB-3PRGD2 radioligand therapy
Radioligand therapy using 177Lu-AB-3PRGD2 80 mCi (2.96 GBq) will be performed 6-weekly. A maximum of 4 cycles will be administered.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
90 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Xiamen University
OTHER
Responsible Party
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Principal Investigators
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Haojun Chen, MD, PhD
Role: STUDY_CHAIR
The First Affiliated Hospital of Xiamen University
Locations
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The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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XMYY-2020KY067-05
Identifier Type: -
Identifier Source: org_study_id
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