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OncoMatch/Clinical Trials/NCT04665947

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

Is NCT04665947 recruiting? Yes, currently enrolling (Jun 2026). This Early Phase 1 trial studies [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G. for metastatic pancreatic cancer.

Early Phase 1RecruitingUniversity of California, DavisNCT04665947Data as of Jun 2026

Treatment: [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.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).

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Extracted eligibility criteria

Treatments studied

Other

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

Cancer type

Pancreatic Cancer

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: systemic chemotherapy

Participant must have documented tumor progression during or following at least one prior systemic regimen

Cannot have received: radiation therapy for advanced or metastatic disease

Previous radiation therapy for the treatment of advanced or metastatic disease

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥ 1000 cells/mm3; Platelet count ≥ 100,000/mm3; Hemoglobin ≥ 8 g/dL; INR>1.2; PTT>5 seconds above UNL [excluded]

Kidney function

Creatinine ≤ 2 times ULN

Liver function

AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN); Total bilirubin ≤ 2 times ULN

Hematologic parameters defined as: ANC ≥ 1000 cells/mm3; Platelet count ≥ 100,000/mm3; Hemoglobin ≥ 8 g/dL. Blood chemistry levels defined as: AST, ALT, alkaline phosphatase ≤ 5 times ULN; Total bilirubin ≤ 2 times ULN; Creatinine ≤ 2 times ULN. INR>1.2; PTT>5 seconds above UNL [excluded]

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of California Davis · Sacramento, California

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Frequently asked questions

Is NCT04665947 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior radiation therapy for advanced or metastatic disease disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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