New 'See and Treat' combo targets tough pancreatic cancer
NCT ID NCT04665947
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
This early-phase study tests a two-part approach for people with advanced pancreatic cancer. First, a special scan identifies cancer cells. Then, a targeted radioactive treatment is given to destroy those cells. The goal is to check safety and find the right dose in 30 participants.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2020
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \[68Ga\]Ga DOTA-5G PET/CT Inclusion Criteria: 1. Ability to understand and willingness to sign a written informed consent document. 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 \[177Lu\]Lu DOTA-ABM-5G therapy Inclusion Criteria: 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: * \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G therapy Exclusion Criteria: 1. Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA) 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of California Davis
Sacramento, California, 95817, United States
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Other studies related to the condition(s) this trial covers.
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