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Locally Advanced Pancreatic AdenocarcinomaPhase 1NCT07608627

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

A Phase 1 study testing Biospecimen Collection, Copper Cu 64-DOTA-A2DM and Positron Emission Tomography in people with Locally Advanced Pancreatic Adenocarcinoma and Metastatic Pancreatic Adenocarcinoma, run by City of Hope Medical Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

This clinical trial tests the safety, side effects, best dose and feasibility of using 64Cu-DOTA A2 scFv-Fc2 DM with positron emission tomography for the imaging of patients with PSCA-expressing pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Copper Cu 64-DOTA-A2DM and Positron Emission Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
16 Dec 2026to 14 Jul 2028
Phase
Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jeffrey Wong, MD contact

626-325-4260

JWong@coh.org

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

    Jeffrey Y. Wong, 626-325-4260, jwong@coh.org

    Jeffrey Y. Wong

Other trials in United States

About this study

Official title: A Phase 1 Clinical Trial of 64Cu-DOTA A2 scFv-Fc2 DM (64Cu-DOTA-A2DM) Positron Emission Tomography in Patients With Metastatic PSCA-Expressing Pancreatic Cancer

This clinical trial tests the safety, side effects, best dose and feasibility of using 64Cu-DOTA A2 scFv-Fc2 DM with positron emission tomography for the imaging of patients with PSCA-expressing pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 64Cu-DOTA A2 scFv-Fc2 DM. Because PSCA expressing pancreatic cancers take up 64Cu-DOTA A2 scFv-Fc2 DM it can be seen with PET. A PET scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Because cancer cells often take up more glucose than normal cells, the pictures can be used to find cancer cells in the body. Using 64Cu-DOTA A2 scFv-Fc2 DM with positron emission tomography may be a safe and feasible way to obtain diagnostic images of patients with locally advanced or metastatic PSCA-expressing pancreatic cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the safety and feasibility of prostate stem cell antigen (PSCA) imaging using 64Cu-DOTA-A2DM in patients with locally advanced or metastatic pancreatic cancer.

SECONDARY OBJECTIVES:

  1. To evaluate images of 64Cu-DOTA-A2DM. II. To determine pharmacokinetics of 64Cu-DOTA-A2DM. III. To determine the optimal unlabeled dose of DOTA-A2DM for radioimmunotherapy trials (RIT).

IV. To conduct radiation dose estimation for RIT trials

OUTLINE: This is a dose escalation study of 64Cu-DOTA A2 scFv-Fc2 DM.

Patients receive unlabeled DOTA-A2DM intravenously (IV) then 2-3 hours later patients receive labeled 64Cu-DOTA-A2DM, over 3-5 minutes on day 0. Patients undergo PET scan on day 1 and 2. Patients undergo urine sample collection during screening and blood sample collection throughout the study.

After completion of study intervention, patients are followed up at 30 and 90 days.

Being tested
Biospecimen Collection, Copper Cu 64-DOTA-A2DM, Positron Emission Tomography, Radioconjugate
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample collection

  • Copper Cu 64-DOTA-A2DMDrug

    Also called 64Cu-DOTA-A2DM, Copper Cu 64-DOTA-A2 scFv-Fc2DM, Copper Cu 64-DOTA-Anti-PSCA Minibody A2DM

    Given 64Cu-DOTA-A2DM IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET scan

  • RadioconjugateOther

    Also called Radio Conjugates

    DOTA-A2DM IV

Study groups in NCT07608627
Study groupRoleWhat they receive
Other (64Cu-DOTA A2 scFv-Fc2 DM with PET scan)ExperimentalPatients receive unlabeled DOTA-A2DM IV then 2-3 hours later patients receive labeled 64Cu-DOTA-A2DM, over 3-5 minutes on day 0. Patients undergo PET scan on day 1 and 2. Patients undergo urine sample collection during screening and blood sample collection throughout the study.
Receives: Procedure: Biospecimen Collection; Drug: Copper Cu 64-DOTA-A2DM; Procedure: Positron Emission Tomography; Other: Radioconjugate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

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

    Measured: Up to 90 days

  2. Dose limiting toxicity

    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.

    Measured: Up to day 2

Secondary outcomes (4)

  1. Radiolabel uptake in prominent lesions and adjacent non-tumor tissue and select organs

    Measured as maximum single-voxel standardized uptake value (SUVmax) and mean standardized uptake value.

    Measured: At day 1 and 2

  2. 64Cu activity concentration

    Measured: At 0-1, 4-6, 21-25, and 46-50 hours after injection

  3. Ratios of tumor to non-tumor activity concentrations

    Measured in the select organs (SUVmean) at different protein doses and time points will be used to determine optimal protein dose.

    Measured: Up to 90 days

  4. Imaging-based dosimetry

    Quantified in the liver, spleen, heart, and the lumbar vertebrae as calculated by organ level internal dose assessment-based standard phantom data.

    Measured: On day 1 and 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2026
  2. Study start16 Dec 2026 (estimated)
  3. Primary completion14 Jul 2028 (estimated)
  4. Study completion14 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07608627
Sponsor's protocol ID
20533
Other IDs
NCI-2026-03338, 20533, P30CA033572, R01CA266665
Status last verified
May 2026
First submitted
20 May 2026
Last updated
27 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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