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Trial Title:
Clinical Evaluation of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression
NCT ID:
NCT06375564
Condition:
Refractory Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Refractory Solid Tumor
Radioligand therapy
177Lu-AB-3PRGD2
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
177Lu-AB-3PRGD2 radioligand therapy
Description:
Radioligand therapy using 177Lu-AB-3PRGD2 80 mCi (2.96 GBq) will be performed 6-weekly. A
maximum of 4 cycles will be administered.
Arm group label:
177Lu-AB-3PRGD2
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.
Detailed description:
Integrin αvβ3 is highly expressed in some tumor cells and neovascularization, which is an
ideal target for diagnosis and treatment of solid tumors. 177Lu-AB-3PRGD2, is a kind of
new drug based on independent research and development in China, providing an effective
target for the treatment of tumors. All patients underwent whole-body 68Ga-RGD PET/CT for
selection and accepted intravenous injection with a fixed dose of 2.96 GBq (80 mCi) of
177Lu-AB-3PRGD2 within one week. Treatment is planned for up to 4 cycles, and the time
interval between cycles is 6 weeks. The primary endpoint assessed the preliminary
treatment efficacy of 177Lu-AB-3PRGD2 used for radioligand therapy in patients with
various advanced tumors. The secondary endpoint evaluates the safety of 177Lu-AB-3PRGD2.
Criteria for 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 (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.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Zip:
361003
Country:
China
Status:
Recruiting
Contact:
Last name:
Haojun Chen
Phone:
+8618659285282
Email:
leochen0821@foxmail.com
Contact backup:
Last name:
Hao Fu, MD, PhD
Phone:
+8615959230059
Email:
fuhaonuclear@163.com
Investigator:
Last name:
Haojun Chen, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Hao Fu, MD, PhD
Email:
Sub-Investigator
Start date:
June 12, 2024
Completion date:
December 30, 2026
Lead sponsor:
Agency:
The First Affiliated Hospital of Xiamen University
Agency class:
Other
Source:
The First Affiliated Hospital of Xiamen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06375564
