For U.S. & E.U. Healthcare Professionals

Trial Design

Trophytrials - TROPHY U-01 is a Phase II trial of sacituzumab govitecanTrophytrials - TROPHY U-01 is a Phase II trial of sacituzumab govitecan

 
 
 

Inclusion criteria

 

Subjects meeting all of the following criteria at screening/Day 1 of treatment will be eligible for participation in the study.

 
  1. Locally advanced or metastatic urothelial cancer
  2. Cohort 1: s/p platinum therapy and anti-PD-1/PD-L1 therapy with CrCl >60 mL/min
  3. Cohort 2: platinum ineligible and s/p anti-PD-1/PD-L1 therapy with CrCl ≥30 mL/min
  4. Adequate organ function
  5. Subjects must have at least a 3-month life expectancy
  6. Have measurable disease by CT or MRI as per RECIST 1.1 criteria
 
 
 

Exclusion criteria

 
  1. Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks or mAB within 4 weeks prior to study Day1
  2. Subjects with Gilbert’s disease
  3. Subjects who previously received irinotecan
  4. Has a known additional malignancy that requires active treatment
  5. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  6. Has active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease) or history of bowel obstruction
  7. Has prior history of clinically significant bleeding, intestinal obstruction, or GI perforation within 6 months of enrollment
  8. Has an active infection requiring systemic therapy or HIV/hepatitis B or C
 
 
 

Locations

Tucson
AZ,USA

Whittier
CA,USA

New Haven
CT,USA

Praha 4 – Krč
Czech Republic

Ostrava-Poruba
Czech Republic

Praha 8 - Libeň
Czech Republic

Praha
Czech Republic

779 00 Olomouc
Czech Republic

Paris Cedex
France

Lyon
France

Villejuif
France

Atlanta
GA,USA

Orbassano
Italy

Rome
Italy

Rome
Italy

Milano
Italy

Alba-Bra
Italy

Naples
Italy

Louisville
KY,USA

Olney
MD,USA

Chevy Chase
MD,USA

Rockville
MD,USA

Ann Arbor
MI,USA

Jackson
MS,USA

Omaha
NE,USA

Albuquerque
NM,USA

Las Vegas
NV,USA

New York
NY,USA

New York
NY,USA

Buffalo
NY,USA

New York
NY,USA

Stony Brook
NY,USA

Kettering
OH,USA

Cleveland
OH,USA

Nashville
TN,USA

The Woodlands
TX,USA

Salt Lake City
UT,USA

Seattle
WA,USA

Madison
WI,USA

Monterey
CA,USA

Whittier 
CA,USA

Glendale 
CA,USA

Santa Ana 
CA,USA

West Covina 
CA,USA

Long Beach 
CA,USA

Lynwood 
CA,USA

Downey 
CA,USA

Corona 
CA,USA
 
 

Contact US

Trophy

For more information about TROPHY U-01
Email Us: TROPHYU01info@immunomedics.com