First-in-human Study of the Theranostic Pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in Pancreatic Cancer
NCT ID: NCT04665947
Last Updated: 2025-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
30 participants
INTERVENTIONAL
2020-12-18
2026-06-30
Brief Summary
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Detailed Description
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The hypotheses of this phase I study are that a) \[68Ga\]Ga DOTA-5G will detect lesions in patients with locally advanced or metastatic pancreas cancer b) the theranostic pair \[68Ga\]Ga DOTA-5G/ \[177Lu\]Lu DOTA-ABM-5G will be safe and well tolerated c) we will be able to identify a Recommended Phase 2 Dose (RP2D) for \[177Lu\]Lu DOTA-ABM-5G therapy to be used in subsequent Phase II trials.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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[177Lu]Lu DOTA-ABM-5G dose escalation therapy study
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. Escalating doses of 25-200 mCi of \[177Lu\]Lu DOTA-ABM-5G will be administered in a traditional 3+3 dose escalation design. After escalation, 10 additional patients will be enrolled into a dose expansion cohort.
[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.
PET imaging using \[68Ga\]Ga DOTA-5G will be used to diagnose patients who are eligible for treatment with the \[177Lu\]Lu DOTA-ABM-5G.
Recommended Phase 2 dose [177Lu]Lu DOTA-ABM-5G therapy study
Patients will be undergo \[68Ga\]Ga DOTA-5G PET/CT scans to confirm eligibility for the \[177Lu\]Lu DOTA-ABM-5G therapy.10 patients will be enrolled in the dose expansion cohort and recieve the highest dose achieved in the \[177Lu\]Lu DOTA-ABM-5G dose escalation therapy study
[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.
PET imaging using \[68Ga\]Ga DOTA-5G will be used to diagnose patients who are eligible for treatment with the \[177Lu\]Lu DOTA-ABM-5G.
Interventions
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[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.
PET imaging using \[68Ga\]Ga DOTA-5G will be used to diagnose patients who are eligible for treatment with the \[177Lu\]Lu DOTA-ABM-5G.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age 18 or more years
3. 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)
4. 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
5. Eastern Cooperative Oncology Group Performance Status ≤ 2
6. 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.
7. Hematologic parameters defined as:
1. Absolute neutrophil count (ANC) ≥ 1000 cells/mm3
2. Platelet count ≥ 100,000/mm3
3. Hemoglobin ≥ 8 g/dL
8. Blood chemistry levels defined as:
1. AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
2. Total bilirubin ≤ 2 times ULN
3. Creatinine ≤ 2 times ULN
9. Anticipated life expectancy ≥ 3 months
10. Able to remain motionless for up to 30-60 minutes per scan
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 lung or liver)
Exclusion Criteria
2. Participants with Class 3 or 4 NYHA Congestive Heart Failure
3. Clinically significant bleeding within two weeks prior to trial entry (e.g. gastrointestinal bleeding, intracranial bleeding)
4. Pregnant or lactating women
5. 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
6. Has an additional active malignancy requiring therapy within the past 2 years
7. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
8. Psychiatric illness/social situations that would interfere with compliance with study requirements
9. Previous radiation therapy for the treatment of advanced or metastatic disease
10. Cannot undergo PET/CT scanning because of weight limits (350 lbs)
11. INR\>1.2; PTT\>5 seconds above UNL
18 Years
ALL
No
Sponsors
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University of California, Davis
OTHER
Responsible Party
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Julie L. Sutcliffe, Ph.D
Professor
Principal Investigators
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Julie L Sutcliffe
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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University of California Davis
Sacramento, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1667622
Identifier Type: -
Identifier Source: org_study_id
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