Study Description
This is a phase Ib/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and tislelizumab) in advanced solid tumor patients. After the determination of the maximum tolerated dose / recommended dose for a particular treatment arm, dose expansion will assess the anti-tumor activity and further assess the safety, tolerability, and PK/PD of each regimen at the maximum tolerated dose / recommended dose or lower dose.
Interventions
JDQ443
tislelizumab
TNO155
Eligibility Criteria
Inclusion Criteria:
Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care or are intolerant or ineligible to approved therapies
ECOG Performance Status of 0 or 1
At least one measurable lesion as defined by RECIST 1.1
Prior treatment with a KRAS G12C inhibitor may be allowed for dose escalations of combinations and a subset of groups in dose expansion
Exclusion Criteria:
Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations
Symptomatic brain metastases or known leptomeningeal disease. Patients with asymptomatic treated or untreated brain metastases may be eligible
Clinically significant cardiac disease or risk factors at screening
A medical condition that results in increased photosensitivity Other protocol-defined inclusion/exclusion criteria may apply.
Study Location
Novartis Investigative Site
Recruiting
Melbourne,Victoria,3000,Australia
Novartis Investigative Site
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Leuven,3000,Belgium
Novartis Investigative Site
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Montreal,Quebec,H2W 1T8,Canada
Novartis Investigative Site
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Nanchang,Jiangxi,330006,China
Novartis Investigative Site
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Beijing,100036,China
Novartis Investigative Site
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Guangzhou,Guangdong,51000,China
Novartis Investigative Site
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Copenhagen,DK-2100,Denmark
Novartis Investigative Site
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Marseille,13273,France
Novartis Investigative Site
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Villejuif,94800,France
Novartis Investigative Site
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Lyon,69373,France
Novartis Investigative Site
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Dresden,01307,Germany
Novartis Investigative Site
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Koeln,50937,Germany
Novartis Investigative Site
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Essen,45147,Germany
Novartis Investigative Site
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Freiburg,79106,Germany
Novartis Investigative Site
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Hong Kong,Hong Kong
Novartis Investigative Site
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Milano,MI,20133,Italy
Novartis Investigative Site
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Milano,MI,20162,Italy
Novartis Investigative Site
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Brescia,BS,25123,Italy
Novartis Investigative Site
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Kashiwa,Chiba,277 8577,Japan
Novartis Investigative Site
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Osaka-city,Osaka,541-8567,Japan
Novartis Investigative Site
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Koto ku,Tokyo,135 8550,Japan
Novartis Investigative Site
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Osaka,545-8586,Japan
Novartis Investigative Site
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Yokohama-city,Kanagawa,241-8515,Japan
Novartis Investigative Site
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Chuo ku,Tokyo,104 0045,Japan
Novartis Investigative Site
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Nagoya,Aichi,466 8560,Japan
Novartis Investigative Site
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Seoul,03722,Korea, Republic of
Novartis Investigative Site
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Amsterdam,1066 CX,Netherlands
Novartis Investigative Site
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Singapore,168583,Singapore
Novartis Investigative Site
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Singapore,119074,Singapore
Novartis Investigative Site
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Barcelona,Catalunya,08035,Spain
Novartis Investigative Site
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Valencia,Comunidad Valenciana,46010,Spain
Novartis Investigative Site
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Santiago De Compostela,Galicia,15706,Spain
Novartis Investigative Site
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Madrid,28050,Spain
Novartis Investigative Site
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Hospitalet de LLobregat,Catalunya,08907,Spain
Novartis Investigative Site
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Malaga,Andalucia,29010,Spain
Novartis Investigative Site
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Tainan,70403,Taiwan
Novartis Investigative Site
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Taipei,10002,Taiwan
Massachusetts General Hospital Cancer Center
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Boston,Rebecca Heist email: [email protected] -- Rebecca Heist,02114 - Massachusetts,United States
Uni of TX MD Anderson Cancer Cntr Dept of MD Anderson CancerCent
Recruiting
Houston,Rebecca Okumah (+1 713 745 3039) email: [email protected] -- Marcelo Vailati Negrao,77030 - Texas,United States
Emory University School of Medicine/Winship Cancer Institute Winship Cancer Center
Recruiting
Atlanta,Obi Okafor email: [email protected] -- Conor E. Steuer,30322 - Georgia,United States
Hillman Cancer Center
Recruiting
Pittsburgh,Lorenzo Sellitto (412-647-8569) email: [email protected] -- Timothy Burns,15232 - Pennsylvania,United States
Providence Cancer Center
Recruiting
Portland,Teresa Song (503-215-2691) email: [email protected] -- Rachel Sanborn,97213 - Oregon,United States
Worldwide Contacts
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