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Imaging Pancreatic Cancer with 64Cu-DOTA A2 scFv-Fc2 DM

This study is testing a new way to image pancreatic cancer using a substance called 64Cu-DOTA A2 scFv-Fc2 DM and a PET scan (Positron Emission Tomography). This substance helps doctors see pancreatic cancer that has spread to nearby tissue or other parts of the body (locally advanced or metastatic) and has a specific marker called PSCA. The main goal is to see if this imaging method is safe and practical, and to understand its side effects. Researchers will also look at the images produced and how the substance moves through the body. This study is for adults aged 18 or older with locally advanced or metastatic pancreatic cancer and a good general health status. About 15 people are planned to join this study.

Study design
This is an interventional study with an unclear status, planning to enroll 15 participants. It is a dose escalation study.
What's involved
You would have blood samples taken and receive 64Cu-DOTA A2 scFv-Fc2 DM intravenously, followed by PET scans on day 1 and 2. Urine samples are also collected.
Compensation
Not stated in the trial record.
Follow-up
You will be followed up at 30 and 90 days after the study intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07608627

64Cu-DOTA A2 scFv-Fc2 DM With Positron Emission Tomography for the Imaging of Patients With Locally Advanced or Metastatic PSCA-Expressing Pancreatic Cancer

Not Yet Recruiting
PHASE1Ages 18+Interventional
City of Hope Medical Center
~15 participants
Updated 2026-05-27 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCopper Cu 64-DOTA-A2DMPositron Emission TomographyRadioconjugate

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 90 days
+1 more outcome measured

Conditions

Locally Advanced Pancreatic Adenocarcinoma
Metastatic Pancreatic Adenocarcinoma
Stage III Pancreatic Cancer AJCC v8
Stage IV Pancreatic Cancer AJCC v8

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NCT07608627

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • City of Hope Medical Center

    Duarte, Californiastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jeffrey Y Wong, MD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Jeffrey Wong, MD
[email protected]
626-325-4260
Email the study team

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Eligibility criteria

Inclusion

Documented informed consent of the participant and/or legally authorized representative
Age: ≥ 18 years
Karnofsky \> 70%
Advanced (locally or metastatic), histologically confirmed pancreatic adenocarcinoma
Evidence of locally advanced unresectable or metastatic disease demonstrated by an abnormal imaging scan (computed tomography \[CT\], magnetic resonance imaging \[MRI\], fludeoxyglucose \[FDG\]-PET) within 8 weeks prior to enrollment
No prior radiation therapy to target lesions
Hemoglobin ≥ 9g/dL
NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement
Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease)
Aspartate aminotransferase (AST) ≤ 3.0 x ULN
Alanine aminotransferase (ALT) ≤ 3.0 x ULN
Serum creatinine \< 1.4 mg/dL
Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Agreement by females and males of childbearing potential\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy.
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)

Exclusion

Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days or five half-lives (whichever is shorter for non-radiation therapy) prior to day 1 of protocol therapy
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
Clinically significant uncontrolled illness
Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Females only: Pregnant or breastfeeding
Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

What this trial measures

  • Incidence of adverse eventsUp to 90 days

    Graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 6.0.

  • Dose limiting toxicityUp to day 2

    Defined as any of the following that occur during the first 2 days post the administration of radiolabeled A2DM that are attributed as possibly, probably, or definitely related to protocol therapy.