Status:
RECRUITING
First-in-human Study of the Theranostic Pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in Pancreatic Cancer
Lead Sponsor:
University of California, Davis
Conditions:
Metastatic Pancreatic Cancer
Locally Advanced Pancreatic Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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 pancr...
Detailed Description
This is a Phase I, first-in-human study to evaluate the safety and efficacy of the \[68Ga\]Ga DOTA-5G /\[177Lu\]Lu DOTA-ABM-5G theranostic pair in patients with locally advanced or metastatic pancreat...
Eligibility Criteria
Inclusion
- \[68Ga\]Ga DOTA-5G PET/CT
- Ability to understand and willingness to sign a written informed consent document.
- Age 18 or more years
- Confirmed presence of locally advanced, unresectable or metastatic pancreatic adenocarcinoma (other pancreatic malignant histologies are excluded) with 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 during or following at least one prior systemic regimen as established by CT or MRI scan within 28 days of enrollment
- Eastern Cooperative Oncology Group Performance Status ≤ 2
- Participant must have completed prior chemotherapy 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
- Anticipated life expectancy ≥ 3 months
- Able to remain motionless for up to 30-60 minutes per scan
- \[177Lu\]Lu DOTA-ABM-5G therapy
- 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 lung or liver)
Exclusion
- \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G therapy
Key Trial Info
Start Date :
December 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04665947
Start Date
December 18 2020
End Date
June 1 2026
Last Update
May 28 2025
Active Locations (1)
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1
University of California Davis
Sacramento, California, United States, 95817