Metastatic Cancer
Conditions
Keywords
integrin, PET, Theranostics, metastatic cancer
Brief summary
This is a Phase I study to evaluate the safety and efficacy of the \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G theranostics pair in patients with metastatic cancer.
Detailed description
This is a Phase I study to evaluate the safety and efficacy of the \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G theranostics pair in patients with metastatic cancer. \[68Ga\]Ga DOTA-5G PET/CT will be used to identify and stratify patients eligible for (and most likely to respond to) the \[177Lu\]Lu DOTA-ABM-5G therapy. Up to 40 patients will be enrolled over a 36-month period with metastatic cancer with a life expectancy of at least 3 months, who demonstrate disease progression after at least 1 prior treatment for metastatic disease and have available archival tissue. The hypothesis are that a) \[68Ga\]Ga DOTA-5G will detect lesions in patients with metastatic cancer, b) the theranostic pair \[68Ga\]Ga DOTA-5G/ \[177Lu\]Lu DOTA-ABM-5G will be safe and well tolerated, and c) a therapeutic response will be achieved with a single dose of \[177Lu\]Lu DOTA-ABM-5G.
Interventions
Patients will be undergo \[68Ga\]Ga DOTA-5G PET/CT scans to confirm eligibility for the \[177Lu\]Lu DOTA-ABM-5G therapy. Patients with sufficient lesion uptake of \[68Ga\]Ga DOTA-5G PET/CT will be offered therapy. Patients will undergo a follow up \[68Ga\]Ga DOTA-5G PET/CT scans to assess tretament efficacy.
Sponsors
University of California, Davis
National Institutes of Health (NIH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\[68Ga\]Ga DOTA-5G PET/CT Inclusion Criteria: 1. Ability to understand and willingness to sign a written informed consent document. 2. Age 18 or more years 3. Pathologically confirmed solid cancer with metastatic disease and measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion \> 1 cm or lymph node \> 1.5 cm in short axis) or PERCIST. 4. Participant must have documented tumor progression for metastatic disease during or following at least one prior FDA approved systemic regimen (Androgen Deprivation allowed) as established by diagnostic imaging. 5. Available archival tumor tissue (excisional, core, or FNA is acceptable). Tissue from a metastatic site is preferred when available. 6. Eastern Cooperative Oncology Group Performance Status ≤ 2 7. Participant must have completed prior systemic therapy at least 2 weeks (washout period) prior to \[68Ga\]Ga DOTA-5G PET scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved to Grade 1 or baseline. 8. Hematologic parameters defined as: Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 8 g/dL 9. Blood chemistry levels defined as: AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) Total bilirubin ≤ 2 times ULN Creatinine ≤ 2 times ULN 10. Anticipated life expectancy ≥ 3 months 11. Able to remain motionless for up to 30-60 minutes per scan \[177Lu\]Lu DOTA-ABM-5G therapy Inclusion Criteria: 1. Completion of entry into \[68Ga\]Ga DOTA-5G PET study and completion of scan 2. The presence of at least one measurable disease by \[68Ga\]Ga DOTA-5G PET/CT (SUVmax\>2-fold above normal SUVmax \>2-fold above normal tissue at site of metastasis e.g. normal lung, bone, brain) and identified on standard of care diagnostic imaging)
Exclusion criteria
\[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| [68Ga]Ga DOTA-5G PET/CT imaging | 2 hours from time of injection | To assess the ability of \[68Ga\]Ga DOTA-5G to detect lesions in patients with metastatic cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| [177Lu]Lu DOTA-ABM-5G treatment | 30 days from time of treatment | To assess the safety and tolerability of a single treatment with \[177Lu\]Lu DOTA-ABM-5G |
| [177Lu]Lu DOTA-ABM-5G treatment efficacy | 60 days from time of treatment | To assess treatment efficacy (response vs. no response) assessed by comparison with a post-treatment scan (standard of care imaging and post second \[68Ga\]Ga DOTA-5G PET/CT, prior to next line of therapy. |
Countries
United States
Contacts
CONTACTJulie L Sutcliffe, Phd
CONTACTJulie L Sutcliffe
PRINCIPAL_INVESTIGATORJulie L Sutcliffe
University of California, Davis
Outcome results
None listed