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CompletedPhase 1NCT00967577
Official study title

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

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studied177Lu-J591

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 2, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Weill Medical College of Cornell University

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Weill Medical College of Cornell University
Interventions being studied
Drug: 177Lu-J591
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Weill Cornell Medical CollegeNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 2, 2022. Always confirm current availability with the study team.

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