Clinical trial NCT05013086: 177Lu-AB-3PRGD2 in Patients With Integrin αVβ3 Positive Tumors
Official title: Therapeutic Efficiency and Response to 177Lu-AB-3PRGD2 in Patients With Integrin αVβ3 Positive Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Integrin αVβ3 Positive Tumors
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, non-controlled, non-randomized study to assess the safety and measure image-based absorbed dose of 177Lu-AB-3PRGD2 in patients with Integrin αVβ3 positive tumors who will undergo radioliagnd therapy using 177Lu-AB-3PRGD2.

Detailed description: Integrin αvβ3 is highly expressed in some tumor cells and neovascularization, which is an ideal target for diagnosis and treatment of Integrin αVβ3 positive tumors. 177Lu-AB-3PRGD2, is a kind of new drug based on independent research and development in China, provide an effective target for the treatment of Integrin αVβ3 positive tumors. All patients underwent whole-body 68Ga-RGD PET/CT for selection and accepted intravenous injection with single dose 1.48 GBq (40 mCi) of 177Lu-AB-3PRGD2 within one week. 1-2 ml venous blood was collected at 5min, 3h, 24h, 72h and 168h after administration to detect radioactivity count, respectively. Then monitored at 3, 24, 48, 72, 96, 120 and 168 h after 177Lu-AB-3PRGD2 administration with serial whole body planar and SPECT/CT imaging (72 or 96h). Analyze and calculate the internal radiation dose of 177Lu-AB-3PRGD2 and evaluate its therapeutic efficiency and response.

Eligibility criteria: Inclusion Criteria:

* patients with clear pathological diagnosis and ineffective or progressing clinical conventional treatment;
* tumor lesions with high RGD untake confirmed on 68Ga-RGD PET/CT within one week before the injection of 177Lu-AB-3PRGD2;
* signed written consent.

Exclusion Criteria:

* the exclusion criteria were a serum creatinine level of more than 150 μmol per liter, a hemoglobin level of less than 10.0 g/dl, a white-cell count of less than 4.0× 109/L, a platelet count of less than 100 × 109/L, a total bilirubin level of more than 3 times the upper limit of the normal range and a serum albumin level of more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve disease, a severe allergy or hypersensitivity to radiographic contrast material, claustrophobia;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Primary outcomes:
measure: StandarStandardized uptake value of 177Lu-AB-3PRGD2 in normal organs and tumors.
timeFrame: 1 year
Secondary outcomes:
measure: Adverse events collection
timeFrame: 2 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Zhaohui Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References: