Clinical trial · Interventional
A Safety and Biodistribution Study of [I-124]-CPD-1028 Injection in Solid Tumours
A Phase 1a, Multi-centre, Open-label, Non-randomized Study to Assess the Safety, Biodistribution and Tumour Uptake of [I-124]-CPD-1028 Injection
NCT02134340CI-TRIAL-00024318completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CPD-1061 | Biological | — | UNRESOLVED |
| [I-124]-CPD-1028 Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [I-124]-CPD-1028 PET/CT
- description
- 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.
- interventionNames
- Drug: [I-124]-CPD-1028 Injection
- Biological: CPD-1061
Primary outcomes (2)
- measure
- Evaluate safety of [I-124]-CPD-1028 Injection
- timeFrame
- Up to 30 days
- description
- 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).
- measure
- Obtain preliminary biodistribution data for [I-124]-CPD-1028
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.