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

NCT04469127 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-04-10

No results posted yet for this study

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.

Conditions

  • Breast Cancer Stage IV

Interventions

DRUG

Lutetium-177-DOTAGA-IAC

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

Sponsors & Collaborators

  • University of Witwatersrand, South Africa

    collaborator OTHER

  • Postgraduate Institute of Medical and Research

    collaborator UNKNOWN

  • Advanced Imaging Projects, LLC

    lead INDUSTRY

Principal Investigators

  • Stanley Satz, Ph.D. · Advanced Imaging Projects

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2025-08-30
Completion
2025-08-30
FDA Drug
Yes

Countries

  • India
  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04469127 on ClinicalTrials.gov