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First-in-human Study of the Theranostic Pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in Pancreatic Cancer

2020-12-18

2026-06

2026-06

30

Study Overview

First-in-human Study of the Theranostic Pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in Pancreatic Cancer

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).

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 pancreatic ductal adenocarcinoma (PDAC). PET imaging using [68Ga]Ga DOTA-5G will be used to diagnose patients who are eligible for the [177Lu]Lu DOTA-ABM-5G. The overall purpose of this study is to identify the dose limiting toxicity (DLT) and recommended phase 2 dose (RP2D) of [177Lu]Lu DOTA-ABM-5G. A 3+3 study design in is proposed to identify the RP2D of [177Lu]Lu DOTA-ABM-5G. An expansion group will receive the RP2D in order to obtain initial estimates of response and additional information on safety of [177Lu]Lu DOTA-ABM-5G. 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.

  • Metastatic Pancreatic Cancer
  • Locally Advanced Pancreatic Adenocarcinoma
  • DRUG: [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.
  • 1667622

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2020-12-10  

N/A  

2025-05-21  

2020-12-10  

N/A  

2025-05-28  

2020-12-14  

N/A  

2025-05  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: [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 DOT

DRUG: [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.
EXPERIMENTAL: 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 escalatio

DRUG: [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.
Primary Outcome MeasuresMeasure DescriptionTime Frame
[68Ga]Ga DOTA-5G PET/CT imagingAssessment of [68Ga]Ga DOTA-5G PET/CT imaging to detect lesions in patients with locally advanced or metastatic pancreatic cancer2 hours from time of injection
[177Lu]Lu DOTA-ABM-5G dose escalation therapyFrequency of dose-limiting toxicities (DLT) of [177Lu]Lu DOTA-ABM-5G at escalating dose levels of [177Lu]Lu DOTA-ABM-5G30 days from time of injection
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Assessment of organ dosimetry of [177Lu]Lu DOTA-ABM-5GAssessment of organ dosimetry of [177Lu]Lu DOTA-ABM-5G using SPECT/CT imaging at various timepoints7-14 days from time of injection

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Julie L Sutcliffe

Phone Number: 916-734-5536

Email: jlsutcliffe@ucdavis.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Julie L Sutcliffe, University of California, Davis

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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