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

NCT02134340 | Completed Phase 1

• 1 other identifier: CPD1028-01
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of the study is to evaluate the safety and biodistribution of \[I-124\]-CPD-1028 Injection in cancer patients with solid tumours.

Conditions

Cancer

Keywords

IGF1R

Outcome Measures

Primary Outcomes (2)

• Evaluate safety of [I-124]-CPD-1028 Injection

  The safety of \[I-124\]-CPD-1028 Injection will be assessed for up to 30 days post injection by measuring the occurrence of adverse events and changes from baseline in physical examination, clinical laboratory parameters, electrocardiogram recordings, and vital signs (blood pressure, heart rate, body temperature, respiratory rate and oxygen saturation).

  Up to 30 days

• Obtain preliminary biodistribution data for [I-124]-CPD-1028

  Biodistribution data will be assessed by quantitative analysis of imaging scans taken 2-3 days and 5-7 days post injection by (1) measuring tumour uptake and background tissue levels in selected regions of interest on whole body images and (2) determining if suitable quantitative imaging metrics can be identified.

  Up to 18 days

Secondary Outcomes (3)

• Measure blood and plasma clearance of [I-124]-CPD-1028 and levels of free [I-124]-Iodide

  Up to 18 days

• Compare [I-124]-CPD-1028 uptake in tumours to IGF-1R expression

  Up to 18 days

• Compare [I-124]-CPD-1028 PET/CT images to other imaging modalities

  Up to 18 days

Study Arms (1)

[I-124]-CPD-1028 PET/CT

EXPERIMENTAL

Administration of \[I-124\]-CPD-1028 Injection followed by a maximum of 3 PET/CT imaging sessions. A pre-targeting dose of CPD-1061 may be given prior to injection of \[I-124\]-CPD-1028.

Drug: [I-124]-CPD-1028 Injection; Biological: CPD-1061

Interventions

[I-124]-CPD-1028 Injection DRUG

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.

[I-124]-CPD-1028 PET/CT

CPD-1061 BIOLOGICAL

\[Optional\] 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.

[I-124]-CPD-1028 PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old with life expectancy \> 12 weeks with confirmed metastatic or unresectable malignancy
• Patients must have progressed after at least first-line chemotherapy and have an Eastern Cooperative Oncology Group (ECOG) status of 0, 1 or 2.
• All patients must have archival tumour samples available and must have verification of IGF-1R expression.
• Patients must have adequate organ and marrow function, vital signs and ECG.
• Females of childbearing potential must not be pregnant and both males and females must use adequate forms of contraception.
• Signed informed consent form
• Subject must be compliant and have a high probability of completing the study.

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from previous treatment.
• Patients who have received a therapeutic radiopharmaceutical in the past year or who are currently receiving any other investigational agents.
• Previous treatment with IGF-1R inhibitors.
• Patients who are currently taking antithyroid medications and lithium or potassium sparing diuretics.
• Subjects with known or suspected allergies or contraindications to the investigational agents and iodine
• Subjects with uncontrolled intercurrent illness
• Female subjects who are pregnant, planning to become pregnant or are lactating and/or breast-feeding.
• Patients with diabetes requiring therapy unless controlled through diet or metformin.
• Subjects who are undergoing monitoring of occupational ionising radiation exposure.
• Subjects with hypothyroidism requiring thyroid supplementation

Sponsors & Collaborators

• Centre for Probe Development and Commercialization: lead

Study Sites (4)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 3Z5, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Sunnybrook Health Science Centre - Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Eric Burak, PhD

  Centre for Probe Development and Commercialization

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: May 9, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 18, 2016

Record last verified: 2016-04

Locations

CA (4)