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
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new theranostic pair, [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G, in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC). This early phase I, first-in-human study aims to assess the safety and effectiveness of these agents and to determine the recommended dose for future studies. The study hypothesizes that [68Ga]Ga DOTA-5G can detect cancer lesions and that the pair will be safe and tolerable for treatment. Participants first undergo PET/CT scans using [68Ga]Ga DOTA-5G to confirm eligibility based on lesion uptake. Those eligible receive escalating doses of [177Lu]Lu DOTA-ABM-5G ranging from 25 to 200 mCi in a standard 3+3 dose escalation design to identify dose limiting toxicities and the recommended phase 2 dose (RP2D). After dose escalation, an additional group of 10 patients receives the RP2D to gather further safety and response data. During the study, participants will be monitored with imaging and clinical assessments at specific time points, including PET/CT scans two hours after injection and evaluation of dose escalation effects 30 days post-injection. Organ dosimetry will be assessed 7 to 14 days after treatment. The study involves no randomization or masking, focusing on safety and initial response in this patient population. The total involvement duration varies according to dose escalation and expansion phases.
CONDITIONS
Brief 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 after at least one prior systemic regimen
- Eastern Cooperative Oncology Group Performance Status of 2 or less
- Completed prior chemotherapy at least 2 weeks before study with resolved toxicities except hair loss and sensory neuropathy
- Absolute neutrophil count of at least 1000 cells/mm3
- Platelet count of at least 100,000/mm3
- Hemoglobin of at least 8 g/dL
- AST, ALT, and alkaline phosphatase levels no more than 5 times the upper limit of normal
- Total bilirubin no more than twice the upper limit of normal
- Creatinine no more than twice the upper limit of normal
- Anticipated life expectancy of 3 months or more
- Ability to remain still for 30 to 60 minutes per scan
- Completion of [68Ga]Ga DOTA-5G PET/CT scan
- At least one measurable lesion on PET/CT with SUVmax greater than twice normal lung or liver uptake
You will not qualify if you...
- Use of any chemical anticoagulant or antiplatelet agents except aspirin
- Class 3 or 4 New York Heart Association congestive heart failure
- Significant bleeding within two weeks before enrollment
- Pregnant or breastfeeding women
- Major surgery under general anesthesia within 28 days before study or planned in next 6 weeks
- Additional active cancer requiring treatment within past 2 years
- Active uncontrolled infections requiring systemic therapy
- Psychiatric or social conditions interfering with study compliance
- Prior radiation therapy for advanced or metastatic disease
- Weight exceeding PET/CT scanner limit of 350 pounds
- INR greater than 1.2 or PTT more than 5 seconds above normal limit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for [68Ga]Ga DOTA-5G PET/CT scan to confirm eligibility
Duration - Up to 30 days from time of injection
Participants who show sufficient lesion uptake on PET/CT will receive escalating doses of [177Lu]Lu DOTA-ABM-5G therapy using a 3+3 dose escalation design or the recommended phase 2 dose in an expansion cohort.
1 dose escalation treatment visit or up to 10 treatment visits in the expansion cohort depending on dose group
Duration - 7 to 14 days after treatment
Participants are monitored for safety and organ dosimetry after [177Lu]Lu DOTA-ABM-5G treatment.
1 to 2 follow-up visits for organ dosimetry and safety assessments
Trial Site Locations
Total: 1 location
1
University of California Davis
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
J
Julie L Sutcliffe
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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