Docetaxel/Prednisone Plus Fractionated 177Lu- J591 Antibody for Metastatic, Castrate-resistant Prostate Cancer

Phase 1 Completed 15 enrolled Weill Medical College of Cornell University

Non-randomizedSingle-groupOpen-labelOther

Summary

The purpose of this study is to test the effectiveness of the experimental drug, 177Lu-J591 antibody in combination with docetaxel chemotherapy against metastatic, castrate-resistant prostate cancer.

Timeline

Start: 2009-05
Primary completion: 2015-12
Completion: 2018-12

Publications

Results Batra JS, Niaz MJ, Whang YE, Sheikh A, Thomas C, Christos P, Vallabhajosula S, Jhanwar YS, Molina AM, Nanus DM, Osborne JR, Bander NH, Tagawa ST. Phase I trial of docetaxel plus lutetium-177-labeled anti-prostate-specific membrane antigen monoclonal antibody J591 (177Lu-J591) for metastatic castration-resistant prostate cancer. Urol Oncol. 2020 Nov;38(11):848.e9-848.e16. doi: 10.1016/j.urolonc.2020.05.028. Epub 2020 Jun 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	J591 177LU	Monoclonal antibody	740 mbq	—
Subject	J591 177LU	Monoclonal antibody	925 mbq	—
Subject	J591 177LU	Monoclonal antibody	1110 mbq	—
Subject	J591 177LU	Monoclonal antibody	1295 mbq	—
Subject	J591 177LU	Monoclonal antibody	1480 mbq	—
Background	Docetaxel	Small molecule	75 mg/m2	Intravenous
Background	Prednisone	Other / unclassified	10 mg	—

Docetaxel/Prednisone Plus Fractionated 177Lu- J591 Antibody for Metastatic, Castrate-resistant Prostate Cancer

Summary

Timeline

Publications

Drugs

Indications