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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

NCT04665947

Description:

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).

Related Conditions:
  • Pancreatic Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: 1667622
  • NCT ID: NCT04665947

Conditions

  • Metastatic Pancreatic Cancer
  • Locally Advanced Pancreatic Adenocarcinoma

Interventions

DrugSynonymsArms
[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.[68Ga]Ga DOTA-5G, [177Lu]Lu DOTA-ABM-5G, [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G theranostic pairRecommended Phase 2 dose [177Lu]Lu DOTA-ABM-5G therapy study

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
[177Lu]Lu DOTA-ABM-5G dose escalation therapy studyExperimentalPatients 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.
  • [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.
Recommended Phase 2 dose [177Lu]Lu DOTA-ABM-5G therapy studyExperimentalPatients 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
  • [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:[68Ga]Ga DOTA-5G PET/CT imaging
Time Frame:2 hours from time of injection
Safety Issue:
Description:Assessment of [68Ga]Ga DOTA-5G PET/CT imaging to detect lesions in patients with locally advanced or metastatic pancreatic cancer

Secondary Outcome Measures

Measure:Assessment of organ dosimetry of [177Lu]Lu DOTA-ABM-5G
Time Frame:7-14 days from time of injection
Safety Issue:
Description:Assessment of organ dosimetry of [177Lu]Lu DOTA-ABM-5G using SPECT/CT imaging at various timepoints

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of California, Davis

Trial Keywords

  • integrin
  • metastatic pancreatic cancer
  • PET
  • theranostic

Last Updated

December 16, 2020