177Lu-AB-3PRGD2 in Patients With Integrin αVβ3 Positive Tumors

Early Phase 1

Recruiting

• Conditions: Integrin αVβ3 Positive Tumors
• Interventions: Drug: 1.48 GBq of 177Lu-AB-3PRGD2

• Registration Number: NCT05013086
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study First Submitted: 2021-08-13
• Study First Submitted QC: 2021-08-13
• Study First Posted: 2021-08-19
• Study Start: 2021-10-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13
• Primary Completion: 2024-10-30
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1.48 GBq of 177Lu-AB-3PRGD2	1.48 GBq of 177Lu-AB-3PRGD2	The patients were intravenously injected with the dose about 1.48GBq (40 mCi) of 177Lu-AB-3PRGD2 and underwent 68Ga-RGD PET/CT scans before and after the treatment.

Primary Outcome Measures

Name	Time	Method
StandarStandardized uptake value of 177Lu-AB-3PRGD2 in normal organs and tumors.	1 year	The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value at each time point in normal organs and tumors will be measured.

Secondary Outcome Measures

Name	Time	Method
Adverse events collection	2 months	Adverse events within 2 months after the injection and scanning of patients will be followed and assessed.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China