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

Status

Terminated

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01632696

Enrollment

Registered

2012-07-03

Start date

2012-06-30

Completion date

2016-05-31

Last updated

2017-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Solid Tumor

Keywords

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

Brief summary

Tumor Imaging of I-124 PGN65 in Solid Tumors

Detailed description

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.

Interventions

DRUGI-124 PGN650 for PET/CT

I-124 PGN650 for PET/CT Day 1, Day 2 and 3.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 protocol.

Design outcomes

Primary

Measure	Time frame
To estimate the intensity and distribution in critical and non-critical organs.	Day 1

Secondary

Measure	Time frame
Demonstrate the safety of tumor imaging in patients with solid cancers.	Day 1, Day 2 and Day 3
The presence of tumor imaging using I-124 PGN650 as a PS-targeting agent.	Day 1, Day 2 and Day 3

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026