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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

Sponsor
University of California, Davis (Other)
Overall Status
Recruiting
CT.gov ID
NCT04665947
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
47.4
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Anticipated 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 doseThis 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 :
Dec 18, 2020
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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

    Primary Outcome Measures

    1. [68Ga]Ga DOTA-5G PET/CT imaging [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    8. Absolute neutrophil count (ANC) ≥ 1000 cells/mm3

    9. Platelet count ≥ 100,000/mm3

    10. Hemoglobin ≥ 8 g/dL

    11. Blood chemistry levels defined as:

    12. AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN)

    13. Total bilirubin ≤ 2 times ULN

    14. Creatinine ≤ 2 times ULN

    15. Anticipated life expectancy ≥ 3 months

    16. 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

    Locations

    Site City State Country Postal Code
    1 University of California Davis Sacramento California United States 95817

    Sponsors and Collaborators

    • University of California, Davis

    Investigators

    • Principal Investigator: Julie L Sutcliffe, University of California, Davis

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Julie L. Sutcliffe, Ph.D, Professor, University of California, Davis
    ClinicalTrials.gov Identifier:
    NCT04665947
    Other Study ID Numbers:
    • 1667622
    First Posted:
    Dec 14, 2020
    Last Update Posted:
    Apr 25, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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, Professor, University of California, Davis
    integrin
    metastatic pancreatic cancer
    PET
    theranostic
    Additional relevant MeSH terms:
    Pancreatic Neoplasms
    1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid

    Study Results

    No Results Posted as of Apr 25, 2022