Clinical Trial · NCT04469127

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

Overview

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.

Sponsor

Unknown Organization

Phase

Phase 1/2

Contacts

Stanley Satz, Ph.D. (STUDY_DIRECTOR)

Rose Satz (CONTACT)

rsatz@advancedimagingprojects.com

5617578666

Stanley Satz, Ph.D. (CONTACT)

ssatz@advancedimagingprojects.com

561-561 286-6842

ClinicalTrials.gov

NCT04469127

Drug / Compound

DOTAGA-IAC

Isotope(s):

Target(s):

αvβ3

Ligand Class: Small Molecules

Chelator: DOTAGA

Eligibility

Inclusion

Hemoglobin (Hb) ≥10 g/dl (transfusion or use of EPO is permitted).
Females of childbearing potential must have a negative serum pregnancy test or have had an intervention that renders pregnancy not possible
Tumor progression resistant or refractory to at least one prior lines of standard chemotherapy which include trastuzumab and/or Ado-trastuzumab with or without chemotherapy agents.
Absolute neutrophil count (ANC) ≥ 1.5 x 109/mL.
Angiogenic breast tumor by immunohistochemistry confirmation.
Baseline LVEF ≥40% measured using echocardiogram or equilibrium isotopic ventriculography
Total bilirubin ≤1.5 mg/dl (higher bilirubin levels are permitted if the patient has Gilbert's syndrome).
Alkaline phosphatase ≤2.5 x ULN. Alkaline phosphatase may be more than 2.5 x ULN only in the case of bone metastases, and AST and ALT less than 1.5 x ULN.
ECOG score ≤3
Adequate organ function, defined as:
Platelets \> 100,000/mm3
Creatinine ≤ 1.5 x upper limit of normal (ULN)
AST or ALT ≤ 2.5 x ULN (or ≤5 x ULN in case of liver metastasis)
Positive scan with PET/CT imaging with 18F-FET PET/CT.

Exclusion

Due to potential radiation safety issues, patients with urinary drainage or diversion (e.g., in-dwelling Foley™ catheter, ureteroileostomy, etc.) will not be enrolled.
Previously received external beam irradiation to a field that one kidney.
Previously received external beam irradiation that includes more than 30% of bone marrow
Received any live (attenuated) vaccines within 30 days prior to Visit.
eGFR ≤ 50.
Additional inclusion criterion for measure human dosimetry
Nephrectomy, renal transplant or concomitant nephrotoxic therapy putting the subject at high risk of renal toxicity during the study.
Previously received external beam irradiation to a field that includes the only known lesion.
Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT and MRI that will result.