Recruitment

Recruitment Status
Completed

Inclusion Criterias

Subject's schedule permits compliance with all study procedures
imaging modalities (bone scan, MRI or CT) OR
Patients with histologically confirmed prostate cancer
...
Subject's schedule permits compliance with all study procedures
imaging modalities (bone scan, MRI or CT) OR
Patients with histologically confirmed prostate cancer
Ability to understand and willingness to sign a written informed consent form
Performance status of 60 or higher on Karnofsky scale
Adult male >/= 18 years of age
biochemical progression (PSA)

Exclusion Criterias

Other severe acute or chronic medical condition that may increase the risk associated with study participation or investigational product administration
Hepatic lab values: Bilirubin>1.5 ULN; AST/ALT >2.5 ULN; Albumin < 2 g/dL; GGT > 2.5 ULN if Alkaline Phostphatase >2.5 ULN
Renal lab values: Creatinine > 1.5 ULN
...
Other severe acute or chronic medical condition that may increase the risk associated with study participation or investigational product administration
Hepatic lab values: Bilirubin>1.5 ULN; AST/ALT >2.5 ULN; Albumin < 2 g/dL; GGT > 2.5 ULN if Alkaline Phostphatase >2.5 ULN
Renal lab values: Creatinine > 1.5 ULN
Previous anaphylactic reaction to huJ591 antibody or FDG imaging
On any new anticancer therapy (GnRH analog allowed) while on the study

Summary

Conditions
Metastatic Prostate Cancer
Type
Interventional
Phase
Phase 1 & Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

IAB2M is an approximately 80 kDA molecular weight antibody fragment (a "Minibody"). Limited (Phase 0/Proof-of-concept) patient experience with this biologic targeting agent has been previously obtained with SPECT imaging Ex-US, demonstrating targeting of soft tissue and bone lesions in advanced meta...

IAB2M is an approximately 80 kDA molecular weight antibody fragment (a "Minibody"). Limited (Phase 0/Proof-of-concept) patient experience with this biologic targeting agent has been previously obtained with SPECT imaging Ex-US, demonstrating targeting of soft tissue and bone lesions in advanced metastatic prostate cancer.

Inclusion Criterias

Subject's schedule permits compliance with all study procedures
imaging modalities (bone scan, MRI or CT) OR
Patients with histologically confirmed prostate cancer
...
Subject's schedule permits compliance with all study procedures
imaging modalities (bone scan, MRI or CT) OR
Patients with histologically confirmed prostate cancer
Ability to understand and willingness to sign a written informed consent form
Performance status of 60 or higher on Karnofsky scale
Adult male >/= 18 years of age
biochemical progression (PSA)

Exclusion Criterias

Other severe acute or chronic medical condition that may increase the risk associated with study participation or investigational product administration
Hepatic lab values: Bilirubin>1.5 ULN; AST/ALT >2.5 ULN; Albumin < 2 g/dL; GGT > 2.5 ULN if Alkaline Phostphatase >2.5 ULN
Renal lab values: Creatinine > 1.5 ULN
...
Other severe acute or chronic medical condition that may increase the risk associated with study participation or investigational product administration
Hepatic lab values: Bilirubin>1.5 ULN; AST/ALT >2.5 ULN; Albumin < 2 g/dL; GGT > 2.5 ULN if Alkaline Phostphatase >2.5 ULN
Renal lab values: Creatinine > 1.5 ULN
Previous anaphylactic reaction to huJ591 antibody or FDG imaging
On any new anticancer therapy (GnRH analog allowed) while on the study

Locations

New York, New York, 10065
New York, New York, 10065

Tracking Information

NCT #
NCT01923727
Collaborators
Not Provided
Investigators
  • Principal Investigator: Neeta Pandit-Taskar, MD Memorial Sloan Kettering Cancer Center
  • Neeta Pandit-Taskar, MD Memorial Sloan Kettering Cancer Center