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 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Metastatic Pancreatic Adenocarcinoma; Locally Advanced Pancreatic Adenocarcinoma
• Intervention / Treatment: Procedure: Biospecimen Collection; Procedure: Positron Emission Tomography; Drug: Copper Cu 64-DOTA-A2DM; Other: Radioconjugate

Detailed Description

PRIMARY OBJECTIVE:

I. 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:

I. 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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jeffrey Wong, MD; Phone Number: 626-325-4260; Email: JWong@coh.org

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center
      • Principal Investigator: Jeffrey Y. Wong
      • Contact: Jeffrey Y. Wong; Phone Number: 626-325-4260; Email: jwong@coh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Other (64Cu-DOTA A2 scFv-Fc2 DM with PET scan); Patients 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.

Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Sample Collection; Procedure: Positron Emission Tomography; Undergo PET scan; Other Names: Medical Imaging, Positron Emission Tomography; PET; PET Scan; Positron Emission Tomography Scan; Positron-Emission Tomography; PT; Positron emission tomography (procedure); Drug: Copper Cu 64-DOTA-A2DM; Given 64Cu-DOTA-A2DM IV; Other Names: 64Cu-DOTA-A2DM; Copper Cu 64-DOTA-A2 scFv-Fc2DM; Copper Cu 64-DOTA-Anti-PSCA Minibody A2DM; Other: Radioconjugate; DOTA-A2DM IV; Other Names: Radio Conjugates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 6.0.	Up to 90 days
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.	Up to day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At day 1 and 2
64Cu activity concentration		At 0-1, 4-6, 21-25, and 46-50 hours after injection
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.	Up to 90 days
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.	On day 1 and 2

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jeffrey Y Wong, MD, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): December 16, 2026
• Primary Completion (Estimated): July 14, 2028
• Study Completion (Estimated): July 14, 2028

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Chemistry Techniques, Analytical; Spectrum Analysis; Specimen Handling; Magnetic Resonance Spectroscopy
• Other Study ID Numbers: 20533 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2026-03338 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01CA266665 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No