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

NCT07608627 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: 20533NCI-2026-03338P30CA033572R01CA266665
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

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

  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

  Up to 90 days

• Imaging-based dosimetry

  On day 1 and 2

Study Arms (1)

Other (64Cu-DOTA A2 scFv-Fc2 DM with PET scan)

EXPERIMENTAL

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; Drug: Copper Cu 64-DOTA-A2DM; Procedure: Positron Emission Tomography; Other: Radioconjugate

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Other (64Cu-DOTA A2 scFv-Fc2 DM with PET scan)

Copper Cu 64-DOTA-A2DM DRUG

Given 64Cu-DOTA-A2DM IV

Also known as: 64Cu-DOTA-A2DM, Copper Cu 64-DOTA-A2 scFv-Fc2DM, Copper Cu 64-DOTA-Anti-PSCA Minibody A2DM

Other (64Cu-DOTA A2 scFv-Fc2 DM with PET scan)

Positron Emission Tomography PROCEDURE

Undergo PET scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Other (64Cu-DOTA A2 scFv-Fc2 DM with PET scan)

Radioconjugate OTHER

DOTA-A2DM IV

Also known as: Radio Conjugates

Other (64Cu-DOTA A2 scFv-Fc2 DM with PET scan)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Specimen Handling; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Jeffrey Y Wong, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Wong, MD

CONTACT

626-325-4260; JWong@coh.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start (Estimated): December 16, 2026
• Primary Completion (Estimated): July 14, 2028
• Study Completion (Estimated): July 14, 2028
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

US (1)