Treatment for tumors with high integrin αVβ3 expression using a new drug

Therapeutic Efficiency and Response to 177Lu-AB-3PRGD2 in Patients With Integrin αVβ3 Positive Tumors

This study is testing a new drug to see if it can safely treat tumors that have a specific protein called integrin αVβ3 in patients.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05013086 on ClinicalTrials.gov

What this trial studies

This open-label, non-controlled, non-randomized study evaluates the safety and effectiveness of 177Lu-AB-3PRGD2 in patients with integrin αVβ3 positive tumors. Patients will undergo whole-body 68Ga-RGD PET/CT imaging to confirm tumor eligibility before receiving a single intravenous dose of 177Lu-AB-3PRGD2. Blood samples will be collected at various time points post-administration to measure radioactivity, and imaging will be conducted to assess the drug's therapeutic efficiency and response. The study aims to analyze the internal radiation dose and monitor patient outcomes over time.

Who should consider this trial

Good fit: Ideal candidates include patients with a confirmed diagnosis of integrin αVβ3 positive tumors who have not responded to standard therapies.

Not a fit: Patients with severe underlying health conditions or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a targeted therapy option for patients with integrin αVβ3 positive tumors that are resistant to conventional treatments.

How similar studies have performed: While this approach is based on novel drug development, similar studies targeting integrin αVβ3 have shown promise in preliminary research.

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Zhaohui Zhu, MD — Peking Union Medical College Hospital
• Study coordinator: Zhaohui Zhu, MD

Conditions Integrin αVβ3 Positive Tumors