Actively Recruiting
First-in-human Study of the Theranostic Pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in Pancreatic Cancer
Led by University of California, Davis · Updated on 2026-04-29
30
Participants Needed
1
Research Sites
367 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase I, first-in-human study to evaluate the safety and efficacy of the \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G theranostic pair in patients with locally advanced or metastatic pancreatic adenocarcinoma (PDAC).
CONDITIONS
Official Title
First-in-human Study of the Theranostic Pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign informed consent
- Age 18 years or older
- Confirmed locally advanced, unresectable or metastatic pancreatic adenocarcinoma with measurable disease per RECIST 1.1
- Documented tumor progression during or after at least one prior systemic treatment within 28 days before enrollment
- Eastern Cooperative Oncology Group performance status of 2 or less
- Completed prior chemotherapy at least 2 weeks before the PET scan, with any significant side effects resolved to Grade 1 or baseline (except hair loss and sensory neuropathy)
- Absolute neutrophil count of at least 1000 cells/mm3
- Platelet count of at least 100,000/mm3
- Hemoglobin level of at least 8 g/dL
- Liver enzymes (AST, ALT, alkaline phosphatase) no more than 5 times the upper limit of normal
- Total bilirubin no more than 2 times the upper limit of normal
- Creatinine no more than 2 times the upper limit of normal
- Life expectancy of at least 3 months
- Ability to remain still for 30 to 60 minutes during scans
- Completion of the [68Ga]Ga DOTA-5G PET scan entry procedure
- Presence of at least one measurable lesion by [68Ga]Ga DOTA-5G PET/CT with SUVmax more than twice normal lung or liver
You will not qualify if you...
- Use of any chemical anticoagulants including antiplatelet agents except aspirin
- Class 3 or 4 New York Heart Association congestive heart failure
- Clinically significant bleeding within two weeks before study entry
- Pregnant or breastfeeding women
- Major surgery within 28 days before study day 1 or planned surgery within 6 weeks
- Additional active cancer requiring treatment within the past 2 years
- Active, uncontrolled infections requiring systemic treatment
- Psychiatric or social conditions interfering with study compliance
- Previous radiation therapy for advanced or metastatic disease
- Unable to undergo PET/CT due to weight over 350 pounds
- International Normalized Ratio (INR) greater than 1.2 or partial thromboplastin time (PTT) more than 5 seconds above normal
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California Davis
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
J
Julie L Sutcliffe
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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