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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

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ClinicalTrials.gov Identifier: NCT04665947
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : May 15, 2023
Sponsor:
Information provided by (Responsible Party):
Julie L. Sutcliffe, Ph.D, University of California, Davis

Study Description
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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 pancreatic adenocarcinoma (PDAC).

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Locally Advanced Pancreatic Adenocarcinoma Drug: [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G. Early Phase 1

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This is a first-in-human 3 + 3 study design to identify dose limiting toxicity and recommended phase 2 dose
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First-in-human Study of the Theranostic Pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in Pancreatic Cancer
Actual Study Start Date : December 18, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/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 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.
 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.
Other Names:
  • [68Ga]Ga DOTA-5G
  • [177Lu]Lu DOTA-ABM-5G
  • [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G theranostic pair
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 escalation therapy study
 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.
Other Names:
  • [68Ga]Ga DOTA-5G
  • [177Lu]Lu DOTA-ABM-5G
  • [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G theranostic pair


Outcome Measures
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Primary Outcome Measures :
  1. [68Ga]Ga DOTA-5G PET/CT imaging [ Time Frame: 2 hours from time of injection ]
    Assessment of [68Ga]Ga DOTA-5G PET/CT imaging to detect lesions in patients with locally advanced or metastatic pancreatic cancer

  2. [177Lu]Lu DOTA-ABM-5G dose escalation therapy [ Time Frame: 30 days from time of injection ]
    Frequency of dose-limiting toxicities (DLT) of [177Lu]Lu DOTA-ABM-5G at escalating dose levels of [177Lu]Lu DOTA-ABM-5G


Secondary Outcome Measures :
  1. Assessment of organ dosimetry of [177Lu]Lu DOTA-ABM-5G [ Time Frame: 7-14 days from time of injection ]
    Assessment of organ dosimetry of [177Lu]Lu DOTA-ABM-5G using SPECT/CT imaging at various timepoints


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04665947


Contacts
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Contact: Julie L Sutcliffe 916-734-5536 jlsutcliffe@ucdavis.edu

Locations
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United States, California
University of California Davis Recruiting
Sacramento, California, United States, 95817
Contact: Julie L Sutcliffe    916-734-5536    jlsutcliffe@ucdavis.edu   
Principal Investigator: Julie Sutcliffe         
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Julie L Sutcliffe University of California, Davis
More Information
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Responsible Party: Julie L. Sutcliffe, Ph.D, Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT04665947    
Other Study ID Numbers: 1667622
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: May 15, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julie L. Sutcliffe, Ph.D, University of California, Davis:
integrin
metastatic pancreatic cancer
PET
theranostic
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
 Pancreatic Diseases
Endocrine System Diseases
1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action