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
  3. Cohort 2: platinum ineligible and s/p anti-PD-1/PD-L1 therapy
  4. CrCl ≥30 mL/min
  5. Adequate organ function
  6. Subjects must have at least a 3-month life expectancy
  7. 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 Day 1
  2. Subjects with Gilbert’s disease
  3. Subjects who previously received irinotecan
  4. Has an active second malignancy
  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) and subjects with a history of bowel obstruction
  7. Has prior history of clinically significant bleeding, intestinal obstruction, or GI perforation within 6 months of enrollment
  8. Has known active Hepatitis B or Hepatitis 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

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

Omaha
NE,USA

New York
NY,USA

New Haven
CT,USA

Albuquerque
NM,USA

The Woodlands
TX,USA

Nashville
TN,USA

Seattle
WA,USA

Las Vegas
NV,USA

Salt Lake City
UT,USA

New York
NY,USA

Buffalo
NY,USA

Ann Arbor
MI,USA

Whittier
CA,USA

Stony Brook
NY,USA

Tucson
AZ,USA

Louisville
KY,USA

Jackson
MS,USA

Henderson
NV,USA

Clinton
MD,USA

Easton
PA,USA

Tampa
FL,USA

Lake Success
NY,USA

Avondale
AZ,USA

Littleton
CO,USA

Pensacola
FL,USA

Brussels
BRUSSELS,BELGIUM

Brussels
BRUSSELS,BELGIUM

Antwerpen
ANTWERPEN,BELGIUM

Antwerpen
ANTWERPEN,BELGIUM

Edegem
ANTWERPEN,BELGIUM

Charleroi
HAINAUT,BELGIUM

Prague
Prague,CZECH REPUBLIC

Ostrava
SEVEROMORAVSKY KRAJ,CZECH REPUBLIC

Prague
Prague,CZECH REPUBLIC

Olomouc
CZECH REPUBLIC

Lyon
Rhones-Alpes,FRANCE

FRANCE

Paris
ILE-DE-FRANCE,FRANCE

Paris
ILE-DE-FRANCE,FRANCE

Suresnes
ILE-DE-FRANCE,FRANCE

Strasbourg Cedex
ALSACE,FRANCE

Toulouse
Midi-Pyrénées,FRANCE

Villejuif Cedex
ILE-DE-FRANCE,FRANCE

Suwon
GYEONGGI-DO,SOUTH KOREA

GOYANG-SI
GYEONGGI-DO,SOUTH KOREA

Seoul
SOUTH KOREA

Yangsan
GYEONGSANGNAM-DO,SOUTH KOREA

Seoul
SOUTH KOREA

Seoul
SOUTH KOREA

Seongnam-si
GYEONGGI-DO,SOUTH KOREA
 
 

Contact US

Trophy

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