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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 : January 22, 2024
Sponsor:
Information provided by (Responsible Party):
Julie L. Sutcliffe, Ph.D, University of California, Davis

Tracking Information
First Submitted Date  ICMJE December 10, 2020
First Posted Date  ICMJE December 14, 2020
Last Update Posted Date January 22, 2024
Actual Study Start Date  ICMJE December 18, 2020
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2020)
  • [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
  • [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
Original Primary Outcome Measures  ICMJE
 (submitted: December 10, 2020)
  • [68Ga]Ga DOTA-5G PET/CT iamging [ Time Frame: 2 hours from time of injection ]
    To assess the ability of [68Ga]Ga DOTA-5G to detect lesions in patients with locally advanced or metastatic pancreatic cancer
  • [177Lu]Lu DOTA-ABM-5G dose escalation therapy [ Time Frame: 30 days from time of injection ]
    To determine the dose-limiting toxicities (DLT) of [177Lu]Lu DOTA-ABM-5G at escalating dose levels
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2020)		 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2020)		 Assessment of organ dosimetry of [177Lu]Lu DOTA-ABM-5G [ Time Frame: 7-14 days from time of injection ]
To assess organ dosimetry of [177Lu]Lu DOTA-ABM-5G using SPECT/CT imaging at various timepoints
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First-in-human Study of the Theranostic Pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in Pancreatic Cancer
Official Title  ICMJE First-in-human Study of the Theranostic Pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in Pancreatic Cancer
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Metastatic Pancreatic Cancer
  • Locally Advanced Pancreatic Adenocarcinoma
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: [68Ga]Ga DOTA-5G and [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 escalation therapy study
    Intervention: Drug: [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 10, 2020)		 30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Julie L Sutcliffe 916-734-5536 jlsutcliffe@ucdavis.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04665947
Other Study ID Numbers  ICMJE 1667622
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Julie L. Sutcliffe, Ph.D, University of California, Davis
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, Davis
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Julie L Sutcliffe University of California, Davis
PRS Account University of California, Davis
Verification Date January 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP