Clinical trial · Interventional
Phase I Study to evaluate124I-A11 PSCA Minibody in Patients With Metastatic Prostate, Bladder and Pancreatic Cancer
A Phase I Open Label Study to Evaluate the Tumor-targeting Properties and Safety of 124I-A11 PSCA Minibody in Patients With Metastatic Prostate, Bladder and Pancreatic Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [124I] PSCA-Minibody PET/CT imaging of the whole body | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All patients
- description
- 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.
- interventionNames
- Radiation: [124I] PSCA-Minibody PET/CT imaging of the whole body
Primary outcomes (1)
- measure
- Assess the safety of [124I] PSCA-Minibody
- timeFrame
- up to 3 months
- description
- 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
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria (subjects must meet all of the following criteria in order to be enrolled in this study): 1. Histological diagnosis of prostate, bladder or pancreatic cancer. 2. 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) 3. Expected survival ≤ 6 months 4. Provide written informed consent and willing to comply with protocol requirement 5. ≥ 18 years of age 6. The following laboratory results should be within the following limits within 4 weeks prior to study day 1: 1. PSA \> 5 (only for prostate cancer patients) 2. Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/l 3. Platelet count ≥ 100 x 10\^9/l 4. Serum bilirubin ≤ 2.0 mg/dl 5. Aspartate amino transaminase (AST) ≤ 2.5 x ULN 6. Alanine aminotransferase (ALT) ≤ 2.5 x ULN 7. Serum creatinine ≤ 2.0 mg/dl (calculated creatinine clearance \> 45 ml/min) 7. Able to undergo imaging studies, as well as conventional bone and body imaging, as well as 124I-A11 PSCA minibody experimental scan. Exclusion Criteria (subjects meeting any of the following criteria will not be enrolled in this study): 1. Inadequate venous access (two antecubital or equivalent venous access sites) 2. Administration of a radionuclide within 5 physical half-lives prior to projected administration of 124I-A11 PSCA minibody 3. New York Heart Association Class III/IV cardiac disease. 4. History of autoimmune hepatitis 5. Treatment with any experimental therapy within 30 days prior to enrollment or current participation in any other interventional clinical study 6. Subjects weighing ≥ 350 lbs or are unable to fit in the imaging gantry 7. Any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data. 8. Iodine Allergy, hyperthyroidism, or Grave's disease. 9. 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.
References
Publications (0)
Data not yet available