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

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT04665947
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Locally Advanced Pancreatic Adenocarcinoma
  • Metastatic Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G. — DRUG
    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.

Study Details

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).

Key Dates

Start date
Dec 18, 2020
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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

Primary Outcome Measure

[68Ga]Ga DOTA-5G PET/CT imaging [ Time Frame: 2 hours from time of injection ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California DavisSacramentoCalifornia95817
Julie L Sutcliffe
[email protected]
916-734-5536
Julie Sutcliffe (PRINCIPAL_INVESTIGATOR)

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By research site
University of California Davis· Sacramento, CA

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