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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

Documented informed consent of the participant and/or legally authorized representative

Age: ≥ 18 years

Karnofsky > 70%

Advanced (locally or metastatic), histologically confirmed pancreatic adenocarcinoma

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Copper Cu 64-DOTA-A2DM
  • Positron Emission Tomography
  • Radioconjugate

Treatment groups

15 Participants
are divided into 1 treatment group

Sponsors and collaborators

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator