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Open-label, Single Arm, Tumor Imaging and Dosimetry Study of I-124 PGN650 in Advanced Solid Tumors

Phase 0
18 Years
Open (Enrolling)
Malignant Solid Tumour

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Trial Information

Open-label, Single Arm, Tumor Imaging and Dosimetry Study of I-124 PGN650 in Advanced Solid Tumors

Up to 12 patients (6 men and 6 women) will be enrolled in this open-label, single-arm, tumor
imaging and dosimetry study of I-124 PGN650 in solid tumors. All eligible patients who give
written, informed consent and meet all inclusion criteria and no exclusion criteria, and
whose laboratory results are within specified limits at the screening visit, will be
enrolled. All study subjects will receive a single intravenous (IV) dose of I-124 PGN650.
Study subjects will have whole body PET/CT imaging at three different timepoints with all
patients having PET/CT at 0 to 60 minutes after injection of I-124 PGN650. Study subjects
will then be assigned to either a 3 to 5-hour or 6 to 8-hour timepoint and either an 18 to
26 hour or 42 to 52 hour post-injection timepoint. Tumor and whole body radioactivity
distribution will be measured.

Inclusion Criteria

Inclusion Criteria

1. Signed informed consent form.

2. Male or female, ≥ 18 years of age.

3. Histologically or cytologically confirmed solid tumors at any stage with at least one
lesion (primary, metastatic, or recurrent) ≥ 1.5 cm in diameter documented by CT. If
the lesion is located in a lymph node, the shortest diameter of the lymph node must
be ≥ 1.5 cm as defined by RECIST 1.1. (Note: See Exclusion Criteria #1.)

4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

5. Adequate baseline hematological and organ function, assessed by laboratory values
prior to study treatment as follows: absolute neutrophil count (ANC) > 1.0 x 109/L;
hemoglobin > 7 g/dL; serum creatinine < 2 x institutional upper limit of normal
(IULN); aspartate transaminase (AST) < 2.5 x IULN; alanine transaminase (ALT) < 2.5 x
IULN; (if liver metastases are present, ALT and AST < 5 x IULN); total bilirubin <
1.5 x IULN.

6. Women of childbearing potential must agree to use adequate contraception (hormonal or
barrier method of birth control, abstinence), for the duration of study participation
(i.e., from dosing day 1 until study day 8). Should a woman become pregnant or
suspect she is pregnant while participating in this study, she must inform her
treating physician immediately.

7. Patient must be willing and able to undergo the imaging studies outlined in the

Exclusion Criteria

1. Only measureable disease (primary or metastatic) is located in or near the thyroid
gland, liver, kidney, or urinary bladder.

2. Medical conditions such as ischemic heart or lung disease that may be considered an
unacceptable risk.

3. Females who are lactating or pregnant.

4. Persistent acute toxicities from prior anti-cancer therapy.

5. History of hypersensitivity to iodine.

6. Known bladder outlet obstruction.

7. Any condition that would in the Investigator's judgment prevents compliance with the
requirements of the protocol.

8. Patients with known history of an autoimmune disease- including but not limited to:
celiac disease, Crohn's disease, dermatomyositis, Grave's disease, systemic lupus
erythematosus, myasthenia gravis, psoriasis, and rheumatoid arthritis.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

To estimate the intensity and distribution in critical and non-critical organs.

Outcome Time Frame:

Day 1

Safety Issue:



United States: Institutional Review Board

Study ID:

PPHM 1201



Start Date:

June 2012

Completion Date:

August 2013

Related Keywords:

  • Malignant Solid Tumour
  • Antibodies, Monoclonal
  • Biologics
  • F(ab')2
  • Positron-emission tomography (PET)
  • Phosphatidylserine (PS)
  • Solid Tumors
  • Tumor Imaging
  • Neoplasms



City of Hope National Medical CenterLos Angeles, California  91010
University of ArkansasLittle Rock, Arkansas  72202
Washington University School of Medicine, Siteman Cancer CenterSt. Louis, Missouri  63110
John Hopkins UniversityBaltimore, Maryland  21231