Phase 1 Study of AlphaMedix™ in Adult Subjects With SSTR (+) NET

Inclusion Criteria:

• ECOG status 0-2.
• Life expectancy of at least 12 weeks.
• Histologically confirmed diagnosis of SSTR (+) NET, unresectable or metastatic.
• Measurable disease per RECIST 1.1 on CT/MRI scans, defined as at least 1 lesion with ≥ 1 cm in longest diameter (LD) (lymph nodes along short axis).
• Appropriate diagnostic imaging studies, at the discretion of the PI including but notlimited to CT, MRI, 18F-FDG PET/CT, NAF PET/CT bone scan, ultrasound, etc. of thetumor region or suspected area within the 4 weeks of dosing day.
• SSTR(+) disease, as evidenced by available FDA approved SSTR imaging (SRI) within 4weeks prior to the first cycle.
• All FDA-approved therapies for which the subject is eligible have been exhausted.
• Recent blood test results (within 2 weeks pre-dose) as follows: Sufficient bone marrowcapacity as defined by white blood cell (WBC) ≥2,500/µl and WBC ≥2,000/µl forsubsequent cycles; platelets ≥ 100,000/µl for the first treatment and ≥75,000 for thesubsequent therapies, hemoglobin (HgB) ≥8.9 g/dl for the first treatment and 8.0 g/dlfor the subsequent therapies, ANC ≥1,500/µl for the first treatment and ≥1,000/µl; forthe subsequent therapies; ALT, AST values ≤3 times upper limit of normal (ULN);Bilirubin: ≤3 times ULN; Serum creatinine ≤150 µmol/liter or 1.7 mg/dl; Negativepregnancy test in women capable of child-bearing within 48 hours of administration;Serum albumin > 3.0 g/L (<3.0 g/L may be acceptable at the discretion of PI, if PT,PTT, and INR are within normal range)

Exclusion Criteria:

• Prior whole-body radiotherapy and PRRT using 177Lu/90Y/111In- DOTATATE/DOTATOC or TAT
• Known hypersensitivity to 68Gallium, Octreotate, or any of the excipients of 68Ga-DOTATATE, AA infusion or AlphaMedix™.
• Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28days) and Sandostatin® (within 1 day) prior to administration of investigational drug.
• Subjects with unusual hematological parameters, including an increased meancorpuscular volume (MCV) (>100,000), and especially in those who had previouschemotherapy, the advice of a hematologist should be sought for adequate furtherwork-up to rule out myelodysplastic syndrome (MDS).
• Any subject who is taking concomitant medications that decrease renal function (suchas aminoglycoside antibiotics).
• Female subjects who are pregnant, lactating or women of childbearing potential notwilling to practice effective contraceptive techniques during the study period and for 8 weeks post-injection or male subjects who have female partners of childbearingpotential not willing to practice abstinence or effective contraception, during thestudy period and for 8 weeks post-injection.
• Current somatic or psychiatric disease/condition that may interfere with theobjectives and assessments of the study.
• Indication for surgical lesion removal with curative potential
• Known brain metastases; unless these metastases have been treated and stabilized 6months prior to enrollment
• Completion of: (1) cytotoxic chemotherapy for less than 6 weeks; (2) a biologicalagent for less than 5 half-lives; and (3) radiation therapy for less than 6 weeksprior to study enrolment,
• Uncontrolled congestive heart failure; subjects suspected of having this conditionneed to show ejection fraction of >55% as determined by multigated acquisition (MUGA)scan.
• Carcinoid heart disease: Prior history of torsade de pointe, or congenital long QTsyndrome; Conditions with screening ECG repolarization difficult to interpret, orshowing significant abnormalities. This includes, but is not limited to: high degreeAV block, pacemaker, atrial fibrillation or flutter; QTcF interval > 480 msec onscreening ECG; Significant hypokalemia at screening (Potassium <3.5 mMol/L);Significant hypomagnesemia at screening (Mg++ <0.7 mMol/L)
• GFR < 35 mL/min