Phase
Condition
Solid Tumors
Neoplasms
Adenocarcinoma
Treatment
FOLFOX
GEMNabP
INCB161734
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
≥18 years old.
Locally advanced or metastatic solid tumor with KRAS G12D mutation.
For Part 1a and Part 2 Combination Groups 1, 2, and 7: Disease progression on priorstandard treatment, intolerance to or ineligibility for standard treatment, declinedavailable therapies that are known to confer clinical benefit, or no standardavailable treatment to improve the disease outcome.
Cohort specific requirements aas defined in the protocol.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion
Exclusion Criteria:
Prior treatment with any KRAS G12D inhibitor
Known additional invasive malignancy within 1 year of the first dose of study drug
History of organ transplant, including allogeneic stem cell transplantation
Significant, uncontrolled medical condition
History or presence of an ECG abnormality
Inadequate organ function
Other protocol-defined Inclusion/Exclusion Criteria may apply
Study Design
Connect with a study center
Chris Obrien Lifehouse
Camperdown, New South Wales 02050
AustraliaSite Not Available
St Vincent'S Hospital Sydney
Darlinghurst, New South Wales 02010
AustraliaSite Not Available
St. Vincent'S Hospital Sydney
Darlinghurst, New South Wales 02010
AustraliaSite Not Available
Chris Obrien Lifehouse
Camperdown 2172563, New South Wales 2155400 02050
AustraliaActive - Recruiting
St Vincent'S Hospital Sydney
Darlinghurst 2169378, New South Wales 2155400 02010
AustraliaActive - Recruiting
The Alfred Hospital
Melbourne, Victoria 03004
AustraliaSite Not Available
Peter Maccallum Cancer Centre
North Melbourne, Victoria 3051
AustraliaSite Not Available
The Alfred Hospital
Melbourne 2158177, Victoria 2145234 03004
AustraliaActive - Recruiting
Peter Maccallum Cancer Centre
North Melbourne 2154912, Victoria 2145234 3051
AustraliaActive - Recruiting
Linear Clinical Research
Nedlands, Western Australia 06009
AustraliaSite Not Available
Linear Clinical Research
Nedlands 2064874, Western Australia 2058645 06009
AustraliaActive - Recruiting
Cliniques Universitaires Ucl Saint-Luc
Brussels, 01200
BelgiumSite Not Available
Cliniques Universitaires Ucl Saint-Luc
Brussels 2800866, 01200
BelgiumActive - Recruiting
Universitair Ziekenhuis Antwerpen (Uza)
Edegem, 02650
BelgiumSite Not Available
Universitair Ziekenhuis Antwerpen (Uza)
Edegem 2799007, 02650
BelgiumActive - Recruiting
Universitair Ziekenhuis (Uz) Leuven
Leuven, 03000
BelgiumSite Not Available
Universitair Ziekenhuis (Uz) Leuven
Leuven 2792482, 03000
BelgiumActive - Recruiting
The Ottawa Hospital Cancer Center
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Princess Margaret Cancer Center
Toronto, Ontario M5G 2M9
CanadaSite Not Available
The Ottawa Hospital Cancer Center
Ottawa 6094817, Ontario 6093943 K1H 8L6
CanadaActive - Recruiting
Princess Margaret Cancer Center
Toronto 6167865, Ontario 6093943 M5G 2M9
CanadaActive - Recruiting
Centre Leon Berard
Lyon, 69373
FranceSite Not Available
Centre Leon Berard
Lyon 2996944, 69373
FranceActive - Recruiting
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole
Toulouse, 31059
FranceSite Not Available
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole
Toulouse 2972315, 31059
FranceActive - Recruiting
Institut Gustave Roussy
Villejuif 2968705, 94805
FranceActive - Recruiting
Institut Gustave Roussy
Villejuif Cedex, 94805
FranceSite Not Available
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, 20133
ItalySite Not Available
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan 3173435, 20133
ItalyActive - Recruiting
Irccs Istituto Clinico Humanitas
Rozzano, 20089
ItalySite Not Available
Irccs Istituto Clinico Humanitas
Rozzano 3168837, 20089
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
Verona, 37134
ItalySite Not Available
Centro Ricerche Cliniche Di Verona
Verona, 37134
ItalySite Not Available
Centro Ricerche Cliniche Di Verona
Verona 3164527, 37134
ItalyActive - Recruiting
National Cancer Center Hospital East
Chiba, 277-8577
JapanSite Not Available
National Cancer Center Hospital East
Chiba 2113015, 277-0882
JapanActive - Recruiting
The Cancer Institute Hospital of Jfcr
Koto-ku, 135-8550
JapanSite Not Available
The Cancer Institute Hospital of Jfcr
Kōtoku 2128852, 135-8550
JapanSite Not Available
The Cancer Institute Hospital of Jfcr
Tokyo 1850147, 135-0063
JapanActive - Recruiting
Hospital General Universitario Vall D Hebron
Barcelona, 08035
SpainSite Not Available
Hospital General Universitario Vall D Hebron
Barcelona 3128760, 08035
SpainActive - Recruiting
Fundacian Jimnez Diaz
Madrid, 28040
SpainSite Not Available
Fundacion Jimenez Diaz
Madrid, 28040
SpainSite Not Available
Hospital Universitario Quironsalud Madrid
Madrid, 28223
SpainActive - Recruiting
Fundacion Jimenez Diaz
Madrid 3117735, 28040
SpainActive - Recruiting
Hospital Universitario Quironsalud Madrid
Madrid 3117735, 28223
SpainActive - Recruiting
Mayo Clinic Hospital
Phoenix, Arizona 85054
United StatesSite Not Available
Mayo Clinic Hospital
Phoenix 5308655, Arizona 5551752 85054
United StatesActive - Recruiting
Stanford University
Palo Alto, California 94305
United StatesSite Not Available
UCLA Healthcare Hematology-Oncology
Santa Monica, California 90404
United StatesSite Not Available
Stanford University
Palo Alto 5380748, California 5332921 94305
United StatesActive - Recruiting
UCLA Healthcare Hematology-Oncology
Santa Monica 5393212, California 5332921 90404
United StatesActive - Recruiting
Sarah Cannon Research Institue At Healthone
Denver, Colorado 80218
United StatesSite Not Available
Sarah Cannon Research Institue At Healthone
Denver 5419384, Colorado 5417618 80218
United StatesActive - Recruiting
Mayo Clinic Florida
Jacksonville, Florida 32224
United StatesSite Not Available
Florida Cancer Specialists
Sarasota, Florida 34232
United StatesSite Not Available
Florida Cancer Specialists
Sarasota 4172131, Florida 4155751 34232
United StatesActive - Recruiting
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 02215
United StatesSite Not Available
Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10022
United StatesActive - Recruiting
Weill Cornell Medicine
New York, New York 10021
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10022
United StatesActive - Recruiting
Weill Cornell Medicine
New York 5128581, New York 5128638 10021
United StatesActive - Recruiting
Jefferson University Hospitals
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesSite Not Available
Scri Oncology Partners
Nashville, Tennessee 37203
United StatesSite Not Available
Scri Oncology Partners - Nashville
Nashville, Tennessee 37203
United StatesSite Not Available
Scri Oncology Partners
Nashville 4644585, Tennessee 4662168 37203
United StatesActive - Recruiting
Md Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Md Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting

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