Phase I Study to evaluate124I-A11 PSCA Minibody in Patients With Metastatic Prostate, Bladder and Pancreatic Cancer

NCT02092948 | Completed Phase 1

• 2 other identifiers: 13-000922MNBD-PROT01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine whether positron emission tomography (PET), using the new imaging drug \[124 I\] PSCA-Minibody can be used for imaging prostate, pancreatic or bladder cancer that has spread to the bones and soft tissues (e.g., lymph nodes, lungs, etc.). The PET imaging drug tested in this study binds to the cell marker called Prostate Stem Cell Antigen (PSCA), which is present on certain prostate, pancreatic and bladder cancers.

Conditions

Prostate Cancer; Pancreatic Cancer; Bladder Cancer

Keywords

metastatic; PSCA; minibody; PET/CT

Outcome Measures

Primary Outcomes (1)

• Assess the safety of [124I] PSCA-Minibody

  Safety measures: adverse events including laboratory adverse events will be graded and summarized according to the National Cancer Institute CTCAE, version 4.03. * Laboratory tests (CBC with differential, platelets, serum electrolytes, BUN, creatinine, chemistry, urine analysis) * Vital signs (upright and supine blood pressure, heart rate, respiratory rate, oral temperature, and weight) * Physical examination * HAMBA tier in serum

  up to 3 months

Secondary Outcomes (2)

• Assess the ability of [124I] PSCA-Minibody to image known metastatic disease

  1 Day of scan

• Compare the sensitivity and specificity of [124I] PSCA-Minibody with conventional imaging

  1 Day of scan

Study Arms (1)

All patients

EXPERIMENTAL

Patients will receive one intravenous dose of 4 mg, 20mg or 40 mg of A11 minibody labeled with 5 mCi (185 MBq) of 124I, followed by \[124I\] PSCA-Minibody PET/CT imaging of the whole body.

Radiation: [124I] PSCA-Minibody PET/CT imaging of the whole body

Interventions

[124I] PSCA-Minibody PET/CT imaging of the whole body RADIATION

Whole body Imaging

All patients

Eligibility Criteria

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

You may qualify if:

• Histological diagnosis of prostate, bladder or pancreatic cancer.
• Evidence of recurrent metastatic disease demonstrated by an abnormal bone scan, CT scan or MRI, or FDG-PET within 6 weeks (with no new interval treatment before imaging trial)
• Expected survival ≤ 6 months
• Provide written informed consent and willing to comply with protocol requirement
• ≥ 18 years of age
• The following laboratory results should be within the following limits within 4 weeks prior to study day 1:
• PSA \> 5 (only for prostate cancer patients)
• Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/l
• Platelet count ≥ 100 x 10\^9/l
• Serum bilirubin ≤ 2.0 mg/dl
• Aspartate amino transaminase (AST) ≤ 2.5 x ULN
• Alanine aminotransferase (ALT) ≤ 2.5 x ULN
• Serum creatinine ≤ 2.0 mg/dl (calculated creatinine clearance \> 45 ml/min)
• Able to undergo imaging studies, as well as conventional bone and body imaging, as well as 124I-A11 PSCA minibody experimental scan.

You may not qualify if:

• Inadequate venous access (two antecubital or equivalent venous access sites)
• Administration of a radionuclide within 5 physical half-lives prior to projected administration of 124I-A11 PSCA minibody
• New York Heart Association Class III/IV cardiac disease.
• History of autoimmune hepatitis
• Treatment with any experimental therapy within 30 days prior to enrollment or current participation in any other interventional clinical study
• Subjects weighing ≥ 350 lbs or are unable to fit in the imaging gantry
• Any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data.
• Iodine Allergy, hyperthyroidism, or Grave's disease.
• Any other disease or medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• ImaginAb, Inc.: collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Pancreatic Neoplasms; Urinary Bladder Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urologic Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alan Pantuck, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 20, 2014
• Study Start: August 22, 2013
• Primary Completion: January 6, 2017
• Study Completion: January 6, 2017
• Last Updated: July 27, 2020

Record last verified: 2016-05

Locations

US (1)