Molecularly Targeted Theranostic Approach for the Detection and Treatment of Metastatic Carcinomas
- Conditions
- Metastatic Cancer
- Interventions
- Drug: [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.
- Registration Number
- NCT06389123
- Lead Sponsor
- University of California, Davis
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
[68Ga]Ga DOTA-5G PET/CT Inclusion Criteria:
- Ability to understand and willingness to sign a written informed consent document.
- Age 18 or more years
- Pathologically confirmed GU, GI, breast, cervical, uterine, or head and neck cancers 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)
- 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.
- Available archival tumor tissue (excisional, core, or FNA is acceptable). Tissue from a metastatic site is preferred when available.
- Eastern Cooperative Oncology Group Performance Status ≤ 2
- 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.
- Hematologic parameters defined as:
Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 8 g/dL
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:
- Completion of entry into [68Ga]Ga DOTA-5G PET study and completion of scan
- The presence of at least one measurable disease by [68Ga]Ga DOTA-5G PET/CT (SUVmax>2-fold above normal bone, brain, lung or liver and identified on standard of care diagnostic imaging)
[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G therapy Exclusion Criteria:
- Participants with Class 3 or 4 NYHA Congestive Heart Failure
- Clinically significant bleeding within two weeks prior to trial. entry (e.g. gastrointestinal bleeding, intracranial bleeding)
- Pregnant or lactating women
- Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to study day 1 or anticipated surgery within the subsequent 6 weeks
- Has an additional active malignancy requiring therapy within the past 2 years (other than early stage, surgically managed basal and squamous skin cancer and in situ malignancies of the breast and cervix)
- Active, uncontrolled bacterial, viral, or fungal infection(s) despite systemic therapy
- Psychiatric illness/social situations that would interfere with compliance with study requirements
- Cannot undergo PET/CT or SPECT/CT scanning because of weight limits (350 lbs.)
- Pathologically confirmed NSCLC with metastatic disease
- INR >2.0: PTT>15 seconds above ULN
- Participant on therapeutic warfarin anticoagulation
- External beam radiation therapy (EBRT) or radiopharmaceutical treatment within 21 days prior to study day 1
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [177Lu]Lu DOTA-ABM-5G single dose therapy study [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G. 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.
- Primary Outcome Measures
Name Time Method [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 Outcome Measures
Name Time Method [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.
Trial Locations
- Locations (1)
The University of California Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States