Clinical trial · Interventional
177Lu-J591 Antibody in Patients With Nonprostate Metastatic Solid Tumors
177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Nonprostate Metastatic Solid Tumors: A Pilot Study
NCT00967577CI-TRIAL-00056290completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 this study is to evaluate changes in tumor blood flow and disease response to the investigation agent, 177Lu-J591.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gliomas | Glioma | ALIAS | 0.90 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 177Lu-J591 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- J591
- interventionNames
- Drug: 177Lu-J591
Primary outcomes (2)
- measure
- Change in tumor perfusion as based on Dynamic Contrast Enhanced (DCE)-MRI study
- timeFrame
- Performed after administration of 177LuJ591 between Day 6-9 and on Day 29.
- measure
- Change in tumor perfusion based on changes in cellularity as assessed using Diffusion-weighted imaging (DWI)
- timeFrame
- Performed after administration of 177LuJ591 between Day 6-9 and on Day 29.
Secondary outcomes (2)
- measure
- Changes in response rate using Response evaluation criteria in solid tumors (RECIST) Criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically, or cytologically documented, advanced stage, malignant adult solid tumors (except prostate cancer) that are refractory to, or recurrent from, standard therapy or for which no curative standard therapy exists. This will include, but is not limited to patients with cancers of the kidney, urothelium, head and neck, breast, non-small cell lung, colorectal, pancreas, ovary, esophagus and gliomas. * Metastatic or recurrent solid tumor malignancy defined by abnormal CT, MRI, PET scan, CXR and/or bone scan * Progressive disease manifest by: Development of new lesions or an increase in size of preexisting lesions on imaging study or by physical examination. * Subjects must have recovered from the acute toxicities of any prior therapy, and not received chemotherapy, radiation therapy or other investigational anticancer therapeutic drug for at least 4 weeks prior to J591 administration in this trial * All subjects must have archived or current tissue (from a primary or metastatic focus) available for PSMA determination. * Subjects on bisphosphonate therapy or denosumab must be on a stable dose and must have started therapy \> 4 weeks prior to protocol therapy. * Subjects will be informed as to the potential risk of procreation while participating on this trial and will be advised to use effective contraception during the entire study period. Females of child-bearing potential must have a negative pregnancy test. Exclusion Criteria: * Use of platelet transfusions within 4 weeks of treatment. * Use of hematopoietic growth factors within 4 weeks of treatment. * Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment. * Prior radiation therapy encompassing \>25% of skeleton. * Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®) * Platelet count \<150,000/mm3 or history of platelet count abnormality or dysfunction. * Absolute neutrophil count (ANC) \<2,000/mm3 * Hematocrit \<30 percent or Hemoglobin \< 10 g/dL * Abnormal coagulation profile (PT or INR, PTT) \> 1.3x upper limit of normal (ULN) unless on therapeutic anticoagulation * Serum creatinine \> 2x ULN * AST (SGOT) \>2.5x ULN * Bilirubin (total) \>1.5x ULN; subjects with known Gilbert's syndrome are eligible if direct bilirubin is within institutional normal limits * Active serious infection * Active angina pectoris or NY Heart Association Class III-IV * ECOG Performance Status \> 2 * Deep vein thrombosis and/or pulmonary embolus within 1 month of enrollment. * Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study. * Prior investigational therapy (medications or devices) within 4 weeks of treatment. * Known history of HIV. * Known leukemia or myelodysplastic syndrome * Prior allergic reaction to Gadolinium contrast. * Life expectancy \< 3 months * If alternative treatments are available, metastatic disease should not be progressing so as to anticipate the necessity of urgent treatment within 12 weeks of enrollment based on clinical assessment of the investigator
References
Publications (0)
Data not yet available
No reference posted for this study.