What is 177Lu-AB-3PRGD2 studying for Integrin αVβ3 positive tumors?

177Lu-AB-3PRGD2 is being studied as a targeted treatment for tumors that express Integrin αVβ3. The trial evaluates how the drug distributes in the body, its safety, and its ability to affect these tumors. Peking Union Medical College Hospital is leading this research to explore new options for patients whose tumors have not responded to standard treatments.

Who may be eligible for this Integrin αVβ3 positive tumors clinical trial?

Adults aged 18 to 80 years with confirmed tumors positive for Integrin αVβ3, whose tumors have not responded to conventional treatments, may be eligible. Both men and women can participate. Important factors include having a recent PET/CT scan showing high tumor uptake and no severe allergies to contrast materials. Please review eligibility criteria for more details.

Is there any cost to participate in this Integrin αVβ3 positive tumors clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to getting to the study site may vary and are not guaranteed to be covered.

Actively Recruiting

Early Phase 1

Age: 18Years - 80Years

All Genders

ID05013086

Therapeutic Efficiency and Response to 177Lu-AB-3PRGD2 in Patients With Integrin V3 Positive Tumors

Led by Peking Union Medical College Hospital · Updated on 2024-06-13

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and therapeutic response of a new drug called 177Lu-AB-3PRGD2 in patients with tumors that test positive for Integrin V3. This drug is designed to target these specific tumors, which express this integrin highly, making it a promising option for diagnosis and treatment. The study is an early phase 1, open-label, non-controlled, and non-randomized trial focused on measuring the radiation absorbed dose and therapeutic effects in patients whose tumors show high uptake of the drug. Participants receive a single intravenous dose of 1.48 GBq 40 mCi of 177Lu-AB-3PRGD2 within one week after a whole-body 68Ga-RGD PETCT scan to confirm tumor suitability. After treatment, blood samples are collected at multiple time points to measure drug radioactivity. Patients undergo serial whole-body planar and SPECTCT imaging at several intervals to monitor the radiation distribution and assess the treatment response. During the study, participants will be closely monitored with repeated imaging and blood tests at scheduled times up to 168 hours post-injection. Researchers will analyze the internal radiation dose absorbed by normal organs and tumors and collect data on any adverse events for up to two months. The primary outcome is the standardized uptake value of the drug in both tumors and normal tissues over a one-year period. The study involves adults aged 18 to 80 years with integrin-positive tumors that have not responded to standard treatments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Patients with a clear pathological diagnosis and ineffective or progressing conventional treatment
Tumor lesions with high uptake confirmed by 68Ga-RGD PET/CT within one week before treatment
Signed written informed consent

You will not qualify if you...

Serum creatinine level above 150 µmol/L
Hemoglobin level less than 10.0 g/dl
White-cell count less than 4.0 × 10⁹/L
Platelet count less than 100 × 10⁹/L
Total bilirubin level more than three times the upper normal limit
Serum albumin level more than 3.0 g/dl
Cardiac insufficiency including carcinoid heart valve disease
Severe allergy or hypersensitivity to radiographic contrast material
Claustrophobia
Any medical condition that may significantly interfere with study compliance as judged by the investigator

Research Team

Zhaohui Zhu, MD

Guochang Wang, MD

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