177Lu-J591 Antibody in Patients With Nonprostate Metastatic Solid Tumors

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate changes in tumor blood flow and disease response to the investigation agent, 177Lu-J591.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins

Criteria

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