NCT04469127

A Phase I/II Multicenter, Open-Label Study of Lu-177-DOTAGA-IAC, for the Treatment of Angiogenic Breast Cancer Patients.

This Study is a Phase I/II Clinical Evaluation of a New Investigational Agent, Lutetium-177-DOTAGA-IAC (HurlutinTM Lu-177) to Treat Patients With Unresectable Angiogenic Breast Cancer.

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Advanced Imaging Projects, LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase I/II clinical evaluation of a new investigational agent, Lutetium-177-DOTAGA-IAC (HurlutinTM Lu-177) to treat patients with unresectable angiogenic breast cancer who have previously been treated with at least one prior line of therapy.

Detailed description

This is a prospective, Phase I/II multi-center, interventional open-label study in a total of up to 100 subjects with angiogenic breast cancer. Phase I is to assess the safety and adequacy of a dose of HurlutinTM Lu-177 for up to three cycles, at 4-week intervals. It will include a dose expansion cohort of up to 20 patients. Phase II is to demonstrate the safety, dose adequacy, anti-tumor activity and efficacy of tumor targeted therapy using Lutetium-177-DOTAGA-IAC , as a second- or third-line treatment to extend survival and improve the quality of life of patients with angiogenic breast cancer.

Conditions

• Breast Cancer Stage IV

Interventions

Type	Name	Description
DRUG	Lutetium-177-DOTAGA-IAC	Study participants be administered therapeutic doses of Lutetium-177-DOTAGA-IAC up to three treatments spaced 4 weeks apart.

Timeline

• Start date: 2024-09-30
• Primary completion: 2025-08-30
• Completion: 2025-08-30
• First posted: 2020-07-13
• Last updated: 2024-04-10

Locations

2 sites across 2 countries: India, South Africa

Regulatory

• FDA-regulated drug study