Phase
Condition
Neoplasms
Treatment
Cetuximab
BMS-986466
Adagrasib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Key Inclusion Criteria:
Part 1:
Individuals with a confirmed diagnosis of advanced KRAS G12C mutant NSCLC, CRC, PDACand BTC that has spread to other parts of the body and cannot be removed surgically,may or may not have received previous treatment with KRAS G12C inhibitors.
For NSCLC and CRC: Individuals must have a documented KRAS G12C mutation status fromNYS or FDA approved/cleared or CE marked test or, when such result is not available,positive KRAS G12C mutation status should be confirmed by a central laboratory inblood sample collected at the time of screening.
For PDAC and BTC: Participants must have a documented KRAS G12Cmutation from NYS orFDA-approved/cleared, or CE-marked test and blood samples will be collected only forretrospective testing.
Are relapsed or refractory to available standard of care treatments.
Part 2:
Individuals with a confirmed diagnosis of advanced KRAS G12C-mutant NSCLC (Part 2A)or CRC (Part 2B) that has spread to other parts of the body and cannot be removedsurgically and have not received previous treatment with KRAS inhibitors.
Individuals must have a documented KRAS G12C mutation from FDA or NYS approved/cleared or CE marked test or, when such result is not available, positive KRAS G12Cmutation status should be confirmed by a central laboratory in blood sample and /ortumor samples collected at the time of screening or from archival biopsies (lessthan 1 year old).
Have failed or disease recurrence or are not able to tolerate after at least 1pervious line of therapy.
Exclusion
Key Exclusion Criteria:
Have tumors with known BARF V600X, PTPN11 or KRASQ61X mutations.
Have or any significant heart disease or condition.
Receiving any medications that are substrate of CYP3A4 or inducers and/ orinhibitors
Note: Other protocol-defined inclusion/exclusion criteria apply.
Study Design
Connect with a study center
Local Institution - 0075
Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ
ArgentinaSite Not Available
Local Institution - 0084
ABB, Ciudad Autónoma De Buenos Aires C1199ABB
ArgentinaSite Not Available
Local Institution - 0076
Buenos Aires, 1431
ArgentinaSite Not Available
Local Institution - 0077
Córdoba, X5000HWE
ArgentinaSite Not Available
Local Institution - 0086
Córdoba, 5002
ArgentinaSite Not Available
Local Institution - 0053
Westmead, New South Wales 2145
AustraliaSite Not Available
Local Institution - 0078
Elizabeth Vale, South Australia 5112
AustraliaSite Not Available
Local Institution - 0049
Brussels, Bruxelles-Capitale, Région De 1200
BelgiumSite Not Available
Local Institution - 0048
Gent, Oost-Vlaanderen 9000
BelgiumSite Not Available
Local Institution - 0050
Leuven, Vlaams-Brabant 3000
BelgiumSite Not Available
Local Institution - 0083
Helsinki, 00029
FinlandSite Not Available
CHU de Bordeaux Hop St ANDRE
Bordeaux, Aquitaine 33075
FranceSite Not Available
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Marseille, Bouches-du-Rhône 13385
FranceSite Not Available
Gustave Roussy
Villejuif, Val-de-Marne 94800
FranceSite Not Available
Centre Hospitalier Universitaire de Poitiers
Poitiers, Vienne 86021
FranceSite Not Available
Hopital Claude Huriez - CHU de Lille
Lille, 59037
FranceSite Not Available
Local Institution - 0020
Lille, 59037
FranceSite Not Available
Local Institution - 0082
Petah Tikva, HaMerkaz 4941492
IsraelSite Not Available
Local Institution - 0081
Tel Aviv, Tell Abīb 6423906
IsraelSite Not Available
Local Institution - 0043
Ravenna, Emilia-Romagna 48121
ItalySite Not Available
Local Institution - 0042
Milan, Milano 20162
ItalySite Not Available
Local Institution - 0046
Rome, Roma 00144
ItalySite Not Available
Local Institution - 0065
Badalona, Barcelona [Barcelona] 08916
SpainSite Not Available
Local Institution - 0069
Barcelona, Barcelona [Barcelona] 08035
SpainSite Not Available
Local Institution - 0066
Madrid, Madrid, Comunidad De 28009
SpainSite Not Available
Local Institution - 0067
Madrid, Madrid, Comunidad De 28041
SpainSite Not Available
Local Institution - 0070
Madrid, Madrid, Comunidad De 28034
SpainSite Not Available
Local Institution - 0068
Sevilla, 41013
SpainSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35294-3300
United StatesSite Not Available
Local Institution - 0047
Los Angeles, California 90067
United StatesSite Not Available
Valkyrie Clinical Trials
Los Angeles, California 90067
United StatesSite Not Available
Local Institution - 0040
Athens, Georgia 30607
United StatesSite Not Available
University Cancer & Blood Center, LLC
Athens, Georgia 30607
United StatesSite Not Available
University Cancer Blood Ctr
Athens, Georgia 30607
United StatesSite Not Available
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Local Institution - 0025
Hackensack, New Jersey 07601
United StatesSite Not Available
Atlantic Health System Morristown Medical Center
Morristown, New Jersey 07960
United StatesSite Not Available
Local Institution - 0008
Morristown, New Jersey 07960
United StatesSite Not Available
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York 10016
United StatesSite Not Available
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