Phase
Condition
Neuroblastoma
Neoplasms
Bladder Cancer
Treatment
Docetaxel
IDE397
Sacituzumab govitecan
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be at least 18 years of age
Advanced or metastatic solid tumor that has progressed on at least one prior line oftreatment or is intolerant to additional effective standard therapy
Have evidence of homozygous loss of MTAP or MTAP deletion
Willing to undergo paired fresh biopsy (pre- and post-treatment) procedure.Exceptions may be made for feasibility and safety concerns
Measurable disease
ECOG performance status <= 1
Adequate organ function
Able to swallow and retain orally administered study treatment
Recovery from acute effects of prior therapy
Able to comply with contraceptive/barrier requirements
Exclusion
Exclusion Criteria:
Known symptomatic brain metastases
Known primary CNS malignancy
Current active liver or biliary disease
Impairment of gastrointestinal (GI) function
Active uncontrolled infection
Clinically significant cardiac abnormalities
Previous treatment with a MAT2A inhibitor and / or PRMT inhibitor or sacituzumabgovitecan
Systemic anti-cancer therapy or major surgery within 4 weeks prior to study entry
Radiation therapy within 2 weeks prior to study entry
Prior irradiation to >25% of the bone marrow
Current use or anticipated need for food or drugs that are known strong CYP3A4/5inhibitors or inducers
Currently receiving another investigational study drug.
Known or suspected hypersensitivity to IDE397/excipients or components
Study Design
Connect with a study center
The Kinghorn Cancer Centre, St Vincent's Health Network Sydney
Darlinghurst, New South Wales 02010
AustraliaSite Not Available
The Kinghorn Cancer Centre, St Vincent's Health Network Sydney
Darlinghurst 2169378, New South Wales 2155400 02010
AustraliaActive - Recruiting
Southern Oncology Clinical Research Unit
Bedford Park, South Australia 05042
AustraliaSite Not Available
Southern Oncology Clinical Research Unit
Bedford Park 2076918, South Australia 2061327 05042
AustraliaCompleted
Institut Bergonie
Bordeaux, Bordeaux Cedex 33076
FranceSite Not Available
Institut Bergonie
Bordeaux 3031582, Bordeaux Cedex 33076
FranceActive - Recruiting
Institut Claudius Regaud - IUCT-Oncopole
Toulouse, Cedex 9 31059
FranceSite Not Available
Institut Claudius Regaud - IUCT-Oncopole
Toulouse 2972315, Cedex 9 31059
FranceActive - Recruiting
Hôpital Timone
Marseille 2995469, Marseille 13005
FranceActive - Recruiting
Hôpital Timone
Marseille, 13005
FranceSite Not Available
Centre Eugène Marquis
Rennes, 35000
FranceSite Not Available
Centre Eugène Marquis
Rennes 2983990, 35000
FranceActive - Recruiting
Universitaetsklinikum Hamburg-Eppendorf (UKE)
Hamburg, 20246
GermanySite Not Available
Universitaetsklinikum Hamburg-Eppendorf (UKE)
Hamburg 2911298, 20246
GermanyActive - Recruiting
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-Do 28644
Korea, Republic ofSite Not Available
National Cancer Center
Goyang-si, Gyeonggi 10408
Korea, Republic ofSite Not Available
CHA University - Bundang Medical Center
Seongnam-si, Gyeonggi 28644
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofActive - Recruiting
Sevrance Hospital
Seoul, 03722
Korea, Republic ofActive - Recruiting
National Cancer Center
Goyang-si 1842485, Gyeonggi-do 1841610 10408
South KoreaActive - Recruiting
CHA University - Bundang Medical Center
Seongnam-si 1897000, Gyeonggi-do 1841610 28644
South KoreaActive - Recruiting
Chungbuk National University Hospital
Cheongju-si 1845604, North Chungcheong 1845106 28644
South KoreaActive - Recruiting
Asan Medical Center
Seoul 1835848, 05505
South KoreaActive - Recruiting
Sevrance Hospital
Seoul 1835848, 03722
South KoreaActive - Recruiting
Vall Hebron Institute of Oncology
Barcelona, 08035
SpainSite Not Available
Vall Hebron Institute of Oncology
Barcelona 3128760, 08035
SpainActive - Recruiting
Hospital Universitario 12 de Octubre (H12O)
Madrid, 28041
SpainActive - Recruiting
NEXT Madrid, Universitary Hospital QuironSAlud
Madrid, 28223
SpainActive - Recruiting
START Madrid-HM - Centro Integral Oncológico Clara Campal (CIOCC)
Madrid, 28050
SpainSite Not Available
Hospital Universitario 12 de Octubre (H12O)
Madrid 3117735, 28041
SpainActive - Recruiting
NEXT Madrid, Universitary Hospital QuironSAlud
Madrid 3117735, 28223
SpainActive - Recruiting
START Madrid-HM - Centro Integral Oncológico Clara Campal (CIOCC)
Madrid 3117735, 28050
SpainActive - Recruiting
Instituto Valenciano de Oncología (IVO)
Valencia, 46009
SpainSite Not Available
Instituto Valenciano de Oncología (IVO)
Valencia 2509954, 46009
SpainActive - Recruiting
National Cheng Kung University Hospital
Tainan 1668355, Tainan 704
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei, Taipei 7280290 100
TaiwanActive - Recruiting
National Cheng Kung University Hospital
Tainan, 704
TaiwanSite Not Available
Honor Health Research Institute
Scottsdale, Arizona 85258
United StatesSite Not Available
Honor Health Research Institute
Scottsdale 5313457, Arizona 5551752 85258
United StatesCompleted
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United StatesSite Not Available
Rockefeller Cancer Institute
Little Rock 4119403, Arkansas 4099753 72205
United StatesActive - Recruiting
City of Hope
Duarte, California 91010
United StatesSite Not Available
Providence Medical Group
Santa Rosa, California 95403
United StatesSite Not Available
City of Hope
Duarte 5344147, California 5332921 91010
United StatesActive - Recruiting
Hoag Memorial Hospital
Newport Beach 5376890, California 5332921 92663
United StatesActive - Recruiting
Providence Medical Group
Santa Rosa 5393287, California 5332921 95403
United StatesSite Not Available
Advent Health
Celebration, Florida 34747
United StatesSite Not Available
Orlando Health Cancer Institute
Orlando, Florida 32806
United StatesSite Not Available
Advent Health
Celebration 4150394, Florida 4155751 34747
United StatesSite Not Available
Orlando Health Cancer Institute
Orlando 4167147, Florida 4155751 32806
United StatesActive - Recruiting
Indiana University Health Hospital
Indianapolis, Indiana 46202
United StatesSite Not Available
Indiana University Health Hospital
Indianapolis 4259418, Indiana 4921868 46202
United StatesCompleted
Markey Cancer Center
Lexington, Kentucky 40536
United StatesSite Not Available
Markey Cancer Center
Lexington 4297983, Kentucky 6254925 40536
United StatesSite Not Available
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland 21287
United StatesSite Not Available
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore 4347778, Maryland 4361885 21287
United StatesActive - Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts 02115
United StatesSite Not Available
Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02115
United StatesActive - Recruiting
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
Barbara Ann Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201
United StatesSite Not Available
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York 10032
United StatesActive - Recruiting
Weill Cornell Medical College
New York, New York 10065
United StatesSite Not Available
Columbia University Medical Center - Herbert Irving Pavilion
New York 5128581, New York 5128638 10032
United StatesActive - Recruiting
Weill Cornell Medical College
New York 5128581, New York 5128638 10065
United StatesCompleted
Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Stephenson Cancer Center
Oklahoma City 4544349, Oklahoma 4544379 73104
United StatesActive - Recruiting
LifeSpan - Brown University
Providence, Rhode Island 02906
United StatesSite Not Available
LifeSpan - Brown University
Providence 5224151, Rhode Island 5224323 02906
United StatesCompleted
SCRI Oncology Partners
Nashville, Tennessee 37203
United StatesSite Not Available
The Sarah Cannon Research Institute/Tennessee Oncology
Nashville, Tennessee 37203
United StatesActive - Recruiting
Sarah Cannon Research Institute
Nashville 4644585, Tennessee 4662168 37203
United StatesActive - Recruiting
MD Anderson
Houston, Texas 77030
United StatesSite Not Available
Next Oncology
San Antonio, Texas 78229
United StatesSite Not Available
MD Anderson
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
Next Oncology
San Antonio 4726206, Texas 4736286 78229
United StatesCompleted
Swedish Cancer Institute
Seattle, Washington 98104
United StatesSite Not Available
Swedish Cancer Institute
Seattle 5809844, Washington 5815135 98104
United StatesActive - Recruiting

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