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

NCT ID: NCT02134340

Last Updated: 2016-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-06-30

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.

Detailed Description

Up to 18 adult participants will be enrolled in this Phase 1a study to evaluate the safety and biodistribution of [I-124]-CPD-1028 Injection in patients with Insulin-like Growth Factor-1R (IGF-1R) upregulated solid tumours. All eligible subjects who have given written informed consent and qualify based on the study's inclusion/exclusion criteria will be enrolled in the study. Each enrolled subject will take part in six visits consisting of a screening visit, an Investigational Product administration visit, 3 assessment visits involving 2-3 Positron Emission Tomography/Computed Tomography (PET/CT) scans, and a follow-up safety telephone call. At Visit 2, subjects will start a course of treatment to protect the thyroid from radioactivity and may receive a pre-targeting dose of an additional investigational agent, CPD-1061.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

[I-124]-CPD-1028 Injection

Intervention Type: 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.

CPD-1061

Intervention Type: 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.

Interventions

[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.

Intervention Type: DRUG

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years old with life expectancy > 12 weeks with confirmed metastatic or unresectable malignancy

2. Patients must have progressed after at least first-line chemotherapy and have an Eastern Cooperative Oncology Group (ECOG) status of 0, 1 or 2.

3. All patients must have archival tumour samples available and must have verification of IGF-1R expression.

4. Patients must have adequate organ and marrow function, vital signs and ECG.

5. Females of childbearing potential must not be pregnant and both males and females must use adequate forms of contraception.

6. Signed informed consent form

7. Subject must be compliant and have a high probability of completing the study.

Exclusion Criteria

1. Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from previous treatment.

2. Patients who have received a therapeutic radiopharmaceutical in the past year or who are currently receiving any other investigational agents.

3. Previous treatment with IGF-1R inhibitors.

4. Patients who are currently taking antithyroid medications and lithium or potassium sparing diuretics.

5. Subjects with known or suspected allergies or contraindications to the investigational agents and iodine

6. Subjects with uncontrolled intercurrent illness

7. Female subjects who are pregnant, planning to become pregnant or are lactating and/or breast-feeding.

8. Patients with diabetes requiring therapy unless controlled through diet or metformin.

9. Subjects who are undergoing monitoring of occupational ionising radiation exposure.

10. Subjects with hypothyroidism requiring thyroid supplementation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Probe Development and Commercialization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Burak, PhD

Role: STUDY_DIRECTOR

Centre for Probe Development and Commercialization

Locations

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Sunnybrook Health Science Centre - Odette Cancer Centre

Toronto, Ontario, Canada

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

CPD1028-01

Identifier Type: -

Identifier Source: org_study_id