Overview

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

Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre for Probe Development and Commercialization
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