Cancer
Conditions
Interventions
89Zr barecetamab DFO
Sponsors
Actinium Pharmaceuticals Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients must have the ability to understand and sign an approved Informed Consent Form. 2. Patients must have the ability to understand and comply with all study requirements. 3. Patients must be = 18 years of age. 4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 5. Patients must have a life expectancy > 6 months. 6. Patients must have = 1 metastasis present on baseline CT, magnetic resonance imaging (MRI), or bone scan imaging obtained = 28 days prior to beginning study therapy. 7. Patients must have recovered to 3.0 g/dL. 9. Patients on a stable bisphosphonate or denosumab regimen for = 30 days prior to enrolment are eligible. 10. HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes are included in this study, or patients who are taking anti-retroviral therapy and have an undetectable viral load, stable CD4+ counts (= 250) and are not manifesting any new, or recurrent AIDs-defining illness, or opportunistic infections. For patients who have partners of childbearing potential: 11. Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the Principal Investigator during the study and for 3 months after last study drug administration Additional criteria
Exclusion criteria
Exclusion criteria: 1. Patients with nephrostomy bags, indwelling catheters or with any urinary obstruction and patients with faecal incontinence will be excluded from the study. 2. Previous treatment with another radionuclide than [177] Lu or hemi-body irradiation prior to study enrolment. 3. Previous treatment with HER3-targeted radiotherapeutic agents is not allowed. Patients with prior treatment with HER3 antibody-drug conjugates are not excluded. 4. Any systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy or biological therapy [including mAbs]) within 28 days prior to day of study enrolment unless agreed with Medical Monitor after specific case review. 5. Any investigational agents within 28 days or > 5 half-lives prior to the day of study treatment. 6. Known hypersensitivity to the components of the study therapy or its analogues. 7. Other concurrent cytotoxic chemotherapy, immunotherapy, targeted radiotherapy, or investigational therapy. 8. Patients with a history of central nervous system (CNS) metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids to maintain neurologic integrity. Patients with epidural disease, spinal disease, and prior cord involvement are eligible if those areas have been treated, are stable, and are not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast). 9. A superscan as seen in the baseline bone scan. (prostate only) 10. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression. 11. Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of ECG-QTc >475ms, uncontrolled infection, active hepatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •To determine dosimetry and PK of 89Zr-barecetamab-DFO | — |
Secondary
| Measure | Time frame |
|---|---|
| • Safety and tolerability of a single injection of imaging agent [89Zr]-barecetamab-DFO | — |
Countries
South Africa
Contacts
Public ContactSavi Chetty Tulsee
Clinical Research Consultant
Outcome results
None listed