A Safety and Biodistribution Study of [I-124]-CPD-1028 Injection in Solid Tumours

PHASE1CompletedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions
Cancer
Interventions
DRUG

[I-124]-CPD-1028 Injection

A single intravenous dose of \[I-124\]-CPD-1028 Injection will be given at Visit 2 (within 21 days of screening Visit 1), and may be followed by whole body PET/CT imaging approximately 3 hours post-injection. PET/CT imaging will occur at Visit 3 (2-3 days after Visit 2) and Visit 4 (5-7 days after Visit 2). PET/CT imaging may also occur at Visit 5 (16-18 days after Visit 2). Visit 6 (28 +/- 2 days after Visit 2) is a follow-up telephone call for a post-treatment safety assessment. At Visits 2-5, whole body biodistribution and tumour uptake will be assessed. At all visits, safety will be assessed.

BIOLOGICAL

CPD-1061

\[Optional\] An intravenous dose of 0.4, 1.4 or 6 mg/kg of body weight of CPD-1061 may be given 1-2 hours prior to injection of \[I-124\]-CPD-1028 at Visit 2. The decision to use CPD-1061 and the dose amount is based on an adaptive design and is dependent on interim reviews of imaging data.

Trial Locations (4)

L8N 3Z5

St. Joseph's Healthcare Hamilton, Hamilton

L8V 5C2

Juravinski Cancer Centre, Hamilton

M4N 3M5

Sunnybrook Health Science Centre - Odette Cancer Centre, Toronto

M5G 2M9

University Health Network - Princess Margaret Cancer Centre, Toronto

All Listed Sponsors
lead

Centre for Probe Development and Commercialization

OTHER

NCT02134340 - A Safety and Biodistribution Study of [I-124]-CPD-1028 Injection in Solid Tumours | Biotech Hunter | Biotech Hunter