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A Study of AIP-303 in HER2 Positive Breast Cancer and/or Metastatic Breast Cancer Patients (Heroine01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04469127
Recruitment Status : Not yet recruiting
First Posted : July 13, 2020
Last Update Posted : July 22, 2020
Sponsor:
Collaborators:
All India Institute of Medical Sciences, New Delhi
University of Lausanne
University of Witwatersrand, South Africa
Postgraduate Institute of Medical and Research
PositronPharma
Università degli studi di Trieste
US Department of Veterans Affairs
Information provided by (Responsible Party):
Advanced Imaging Projects, LLC

Brief Summary:
The HEROINE-Breast01 study is a Phase I/II clinical study of a new investigational agent, AIP-303 to help patients with metastatic or unresectable HER2-positive breast cancer and for women with previously treated HER2 positive breast cancer who have gone through at least two prior lines of treatment and received other HER-2-targeted drugs, Trastuzumab or Ado-Trastuzumab and chemotherapy as part of earlier treatments and who have progressed on one or more available therapies. AIP-303 may help slow down tumor growth and this might improve outcomes and quality-of-life for these patients.

Condition or disease Intervention/treatment Phase
HER2 Positive Breast Cancer Drug: AIP-303 Phase 1 Phase 2

Detailed Description:
This is a prospective, Phase I/II, multi-center, open-label study in a total of 150 subjects with HER2 Positive Breast cancer tumors. Eligible participants will undergo baseline assessments at enrollment. Study participants be administered therapeutic doses of AIP-303 up to four treatments spaced 8 weeks apart and a CT scan immediately after. An AIP 301 Ga-68 PET/CT scan will be performed four weeks before and four weeks after the initial dose of the AIP-303. An IEC will review the protocol and any amendments and advertisements used for recruitment. The IEC will review the patient information sheet and the informed consent form, their updates (if any), and any written materials given to the patients. A list of all IECs to which the protocol has been submitted and the name of the committee chairmen will be included in the clinical trial report.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Multicenter, Open-Label Study of AIP-303, for HER2-Positive Unresectable and/or Metastatic Breast Cancer Patients Resistant or Refractory to Trastuzumab or Ado-Trastuzumab and Chemotherapy (Heroine-Breast 01)
Estimated Study Start Date : August 30, 2020
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Arm 1
Single Arm study
Drug: AIP-303
Study participants be administered therapeutic doses of AIP-303 up to four treatments spaced 8 weeks apart and a CT scan immediately after. An AIP 301 Ga-68 PET/CT scan will be performed four weeks before and four weeks after the initial dose of the AIP-303.




Primary Outcome Measures :
  1. Specific Aim 1 [ Time Frame: 6 Months ]

    Demonstrate safety, tolerability and side-effects of the standard dose of 7.4 GBq (200 mCi). (Phase Ib).

    Measurements used to assess the safety, tolerability and side-effects profile will include adverse events of any grade, grade 3 and 4 adverse events, withdrawals due to adverse events and dose reductions due to adverse events. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v.5.0) will be used to evaluate AE grade.



Secondary Outcome Measures :
  1. Specific Aim 2 [ Time Frame: 6 Months ]
    1. PFS (Phase Ib/II). Percentage of subjects still alive without disease getting worse or without progression (according to RECIST 5.0 Criteria).

  2. Specific Aim 3 [ Time Frame: 6 Months ]
    2. ORR (Phase II): Percentage of subjects still alive. Percentage of subjects who achieved a best overall response

  3. Specific Aim 4 [ Time Frame: 6 Months ]
    3. Demonstrate Time to Response: Time to response is defined as the time from the start of treatment until first documented evidence of PR or CR (whichever status is recorded first) (Phase Ib/II).

  4. Specific Aim 5 [ Time Frame: 6 Months ]
    4. Demonstrate Duration of Response: [Time Frame: From the first documented evidence of a CR or a PR until the first documented sign of disease progression or death, whichever occurred earlier (up to 180 Days).]

  5. Specific Aim 6 [ Time Frame: 6 Months ]
    5. OS (Phase Ib): Percentage of subjects still alive. Percentage of subjects who achieved best overall survival.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Patients with HER2+ metastatic solid tumors (may be 3+ by immunohistochemistry or with evidence of gene amplification (>2.0) by fluorescence in situ hybridization (FISH))

    • Currently experiencing tumor progression on active Trastuzumab, Ado-Trastuzumab/Taxane and/or standard of care.
    • At least 18 years of age
    • The patient is able and willing to comply with the requirements of this trial protocol.
    • Able to provide informed consent. Karnofsky score greater than 50
    • Females of childbearing potential must have a negative pregnancy test at screening/ baseline
    • AIP 301 positive scan define by SUV greater than 10.
    • Adequate organ function, defined as:

      1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
      2. Hemoglobin (Hb) ≥9 g/dl (transfusion or use of EPO is permitted).
      3. Platelets > 100,000/mm3
      4. Creatinine ≤ 1.5 x normal value
      5. AST or ALT ≤ 2.5 x ULN (or ≤5 x ULN in case of liver metastasis)
      6. 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.
      7. Total bilirubin ≤1.5 mg/dl (higher bilirubin levels are permitted if the patient has Gilbert's syndrome).
    • Baseline LVEF ≥50% measured using echocardiogram or equilibrium isotopic ventriculography (MUGA).

Exclusion Criteria:

  • • Must not have HER2+ Brain Mets

    • Serious underlying disease other than HER2+ breast cancer in the opinion of the investigator.
    • History of drug addiction within the last 1 year or current drug addiction or use of illicit drugs.
    • Any indication of the regular use of more than 40 grams of alcohol every day.
    • Smokers who smoke more than 10 cigarettes per day.
    • Known concurrent acute or chronic viral hepatitis B or C infection or human immunodeficiency virus (HIV) infection.
    • Presence or history of active tuberculosis (TB) or latent TB infection, defined as 1) a positive QuantiFERON-TB Gold test at Screening, or 2) a positive T-spot test within 4 weeks of visit 3 and evidence of current or previous pulmonary tuberculosis by chest X-ray within 12 weeks of Visit 3.
    • Positive immunoglobulin M antibody titers in the presence of negative immunoglobulin G titers to Epstein-Barr virus (EBV).
    • If clinical suspicion of cytomegalovirus (CMV), cytomegalovirus testing should be undertaken. Subjects with intestinal mucosa biopsy positive for cytomegalovirus at screening are to be excluded.
    • Currently taking any medications other than those allowed per protocol guidelines.
    • Infections (including diverticulitis) requiring treatment with antibiotics, antivirals, or antifungals within 14 days prior to Visit.
    • Serum creatinine >3.0 mg/dL (270 μM/L)
    • Known severe allergy or hypersensitivity to IV radiographic contrast.
    • Use of any other investigational product or device within 30 days prior to dosing or known requirement for any other investigational agent prior to completion of all scheduled study assessments.
    • 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
    • Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
    • Recognized concurrent active infection
    • Previous Grade 3 or higher allergic reaction to Trastuzumab or Ado-Trastuzumab that resulted in discontinuation of Trastuzumab or Ado-Trastuzumab therapy. Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
    • Moderate to severe anemia (hemoglobin <9 g/dL), or thrombocytopenia (platelet count <75,000/μL), or serum creatinine >2 mg/dL.
    • Primary or secondary immunodeficiency including neutropenia (absolute neutrophil count <1500/μL); or lymphopenia (absolute lymphocyte count <500/μL).
    • Hepatic enzyme levels more than 5 times upper limit of normal: Known clinically relevant chronic liver disease.

Impaired hepatic function in the absence of a diagnosis of primary sclerosing cholangitis (serum transaminases >2.5 x upper limit of normal [ULN], alkaline phosphatase >2.5 x ULN, or abnormalities in synthetic liver function tests judged by the investigator to be clinically significant), or a diagnosis of primary sclerosing cholangitis, serum transaminases >3 x ULN, alkaline phosphatase >3 x ULN, or abnormalities in synthetic liver function tests (total bilirubin >1.5 x ULN) judged by the investigator to be clinically significant.

  • Received any live (attenuated) vaccines within 30 days prior to Visit.
  • Recent 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.
  • Peptide receptor radionuclide therapy (PRRT) at any time prior to enrolment in the study.
  • Receipt of cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 30 days prior to Visit.
  • Treatment with therapeutic enema or suppository, other than required for endoscopy preparation, within 14 days prior to the screening endoscopy and during the remainder of the trial.
  • Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04469127


Contacts
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Contact: Stanley Satz, Ph.D. 561-561 286-6842 ssatz@advancedimagingprojects.com
Contact: Rose Satz 5617578666 rsatz@advancedimagingprojects.com

Locations
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United States, Iowa
Department of Veterans Affairs
Iowa City, Iowa, United States, 52242
Contact: David L Bushnell, M.D.    319-384-7306    david-bushnell@uiowa.edu   
Chile
PositronPharma
Santiago, Chile, 878
Contact: Horatio Amaral, M.D.    +56 2 24205137    contacto@positronpharma.cl   
India
All India Institute of Medical Sciences
New Delhi, Dehli, India, 110029
Contact: C.S. Bal, M.D./Ph.D.       drcsbal@gmail.com   
Postgraduate Institute of Medical and Research
Chandigarh, India, 160 012
Contact: Br Mittal, M.D./Ph.D.    +911722756722    brmittal@yahoo.com   
Italy
Università degli Studi di Trieste
Cremona, Italy, 26100
Contact: Daniele Generali, M.D.    +39(0)372408042    dgenerali@units.it   
South Africa
University of Witwatersrand
Johannesburg, South Africa, 2000
Contact: Mboyo Di-Tamba Vangu, M.D./Ph.D.       Mboyo-Di-Tamba.Vangu@wits.ac.za   
Switzerland
University of Lausanne
Lausanne, Switzerland, 1011
Contact: John O Prior, M.D.    +41 21 314 3048    John.Prior@chuv.ch   
Sponsors and Collaborators
Advanced Imaging Projects, LLC
All India Institute of Medical Sciences, New Delhi
University of Lausanne
University of Witwatersrand, South Africa
Postgraduate Institute of Medical and Research
PositronPharma
Università degli studi di Trieste
US Department of Veterans Affairs
Investigators
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Study Director: Stanley Satz, Ph.D. Advanced Imaging Projects
Publications of Results:
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Responsible Party: Advanced Imaging Projects, LLC
ClinicalTrials.gov Identifier: NCT04469127    
Other Study ID Numbers: 145358
First Posted: July 13, 2020    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD is to be shared with researchers
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 1 Yr.
Access Criteria: Contact Sponsor

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases