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

Noch nicht rekrutierend


August 2020

Letztes Update:


Indikation (Clinical Trials):
Breast Neoplasms


Erwachsene (18+)


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,


Stanley Satz, Ph.D.
Study Director
Advanced Imaging Projects


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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.


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


Primary outcome:

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:

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.

Geprüfte Regime

  • 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.


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