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

This dose escalation study will include a maximum of 50 subjects with histologically
confirmed NET, a positive somatostatin analogue scan, and no prior history of PRRT therapy.

The study will begin with a single ascending dose (SAD) of AlphaMedix™ administered by IV.
Subsequent cohorts will receive an incremental 30% increase that will continue until tumor
response or DLT. Once tumor response is observed, the study will convert to a Multiple
Ascending Dose (MAD) regimen. The MAD treatment regimen will start with the previous safe
cohort's dose and will consist of 3 IV administrations of AlphaMedix™ at 8-week intervals.
Subsequent cohorts will receive an incremental 30% increase that will continue until tumor
response or DLT.

The primary objective is to assess the safety and dose limiting toxicity (DLT) using
ascending doses of AlphaMedix™. The secondary objectives are to determine the pharmacokinetic
properties and preliminary effectiveness of AlphaMedix™.

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 not
limited to CT, MRI, 18F-FDG PET/CT, NAF PET/CT bone scan, ultrasound, etc. of the
tumor region or suspected area within the 4 weeks of dosing day.

- SSTR(+) disease, as evidenced by available FDA approved SSTR imaging (SRI) within 4
weeks 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 marrow
capacity as defined by white blood cell (WBC) ≥2,500/µl and WBC ≥2,000/µl for
subsequent cycles; platelets ≥ 100,000/µl for the first treatment and ≥75,000 for the
subsequent therapies, hemoglobin (HgB) ≥8.9 g/dl for the first treatment and 8.0 g/dl
for the subsequent therapies, ANC ≥1,500/µl for the first treatment and ≥1,000/µl; for
the 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; Negative
pregnancy 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 28
days) and Sandostatin® (within 1 day) prior to administration of investigational drug.

- Subjects with unusual hematological parameters, including an increased mean
corpuscular volume (MCV) (>100,000), and especially in those who had previous
chemotherapy, the advice of a hematologist should be sought for adequate further
work-up to rule out myelodysplastic syndrome (MDS).

- Any subject who is taking concomitant medications that decrease renal function (such
as aminoglycoside antibiotics).

- Female subjects who are pregnant, lactating or women of childbearing potential not
willing to practice effective contraceptive techniques during the study period and for
8 weeks post-injection or male subjects who have female partners of childbearing
potential not willing to practice abstinence or effective contraception, during the
study period and for 8 weeks post-injection.

- Current somatic or psychiatric disease/condition that may interfere with the
objectives and assessments of the study.

- Indication for surgical lesion removal with curative potential

- Known brain metastases; unless these metastases have been treated and stabilized 6
months prior to enrollment

- Completion of: (1) cytotoxic chemotherapy for less than 6 weeks; (2) a biological
agent for less than 5 half-lives; and (3) radiation therapy for less than 6 weeks
prior to study enrolment,

- Uncontrolled congestive heart failure; subjects suspected of having this condition
need 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 QT
syndrome; Conditions with screening ECG repolarization difficult to interpret, or
showing significant abnormalities. This includes, but is not limited to: high degree
AV block, pacemaker, atrial fibrillation or flutter; QTcF interval > 480 msec on
screening ECG; Significant hypokalemia at screening (Potassium <3.5 mMol/L);
Significant hypomagnesemia at screening (Mg++ <0.7 mMol/L)

- GFR < 35 mL/min