Status:
NOT_YET_RECRUITING
A Phase I/II Multicenter, Open-Label Study of Lu-177-DOTAGA-IAC, for the Treatment of Angiogenic Breast Cancer Patients.
Lead Sponsor:
Advanced Imaging Projects, LLC
Collaborating Sponsors:
University of Witwatersrand, South Africa
Postgraduate Institute of Medical and Research
Conditions:
Breast Cancer Stage IV
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief 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 previou...
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 o...
Eligibility Criteria
Inclusion
- Angiogenic breast tumor by immunohistochemistry confirmation.
- Positive scan with PET/CT imaging with 18F-FET PET/CT.
- 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.
- At least 18 years of age
- The patient is able and willing to provide informed consent and to comply with the requirements of this trial protocol.
- ECOG score ≤3
- Females of childbearing potential must have a negative serum pregnancy test or have had an intervention that renders pregnancy not possible
- Adequate organ function, defined as:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/mL.
- Hemoglobin (Hb) ≥10 g/dl (transfusion or use of EPO is permitted).
- 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)
- 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.
- Total bilirubin ≤1.5 mg/dl (higher bilirubin levels are permitted if the patient has Gilbert's syndrome).
- Baseline LVEF ≥40% measured using echocardiogram or equilibrium isotopic ventriculography
Exclusion
- Previously received external beam irradiation that includes more than 30% of bone marrow
- Previously received external beam irradiation to a field that one kidney.
- Previously received external beam irradiation to a field that includes the only known lesion.
- Any uncontrolled significant medical, psychiatric or surgical condition or laboratory finding that would pose a risk to subject safety or interfere with study participation or interpretation of individual subject results.
- Nephrectomy, renal transplant or concomitant nephrotoxic therapy putting the subject at high risk of renal toxicity during the study.
- eGFR ≤ 50.
- Bone metastases are the only known lesions.
- 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.
- Inability to lie still for the entire imaging time (e.g., cough, severe arthritis, etc.).
- Use of any other investigational therapeutic product within 30 days prior to dosing or known requirement for any other investigational agent prior to completion of all scheduled study assessments.
- Recognized concurrent active infection.
- Received any live (attenuated) vaccines within 30 days prior to Visit.
- Recent or chronic treatment with medium-to-high-dose intravenous corticosteroids (methylprednisolone 60 mg/day or hydrocortisone 300 mg/day) within 8 weeks prior to Visit or oral corticosteroids of more than 20 mg prednisone (or equivalent) within 30 days prior to Visit
- Any unresolved NCI-CTCAE Grade 2 or higher (except alopecia) from previous anti-tumour treatment and/or medical/surgical procedures/interventions.
- Additional inclusion criterion for measure human dosimetry
- Unable to comply with the requirements of the dosimetry imaging protocol
- Due to potential radiation safety issues, patients with urinary drainage or diversion (e.g., in-dwelling Foley™ catheter, ureteroileostomy, etc.) will not be enrolled.
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04469127
Start Date
September 30 2024
End Date
August 30 2025
Last Update
April 10 2024
Active Locations (2)
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1
Postgraduate Institute of Medical and Research
Chandigarh, India, 160 012
2
CM Johannesburg Academic Hospital, University of the Witwatersrand
Johannesburg, South Africa, 2193