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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 (May 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 May 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

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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