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Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
Sponsor: Novartis Pharmaceuticals
Summary
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.
Official title: A Phase Ib/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
344
Start Date
2021-02-24
Completion Date
2027-01-25
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
JDQ443
KRAS G12C inhibitor
TNO155
SHP2 inhibitor
tislelizumab
Anti PD1 antibody
Locations (38)
Emory University School of Medicine-Winship Cancer Institute
Atlanta, Georgia, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas, United States
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Leuven, Belgium
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Copenhagen, Denmark
Novartis Investigative Site
Lyon, France
Novartis Investigative Site
Marseille, France
Novartis Investigative Site
Villejuif, France
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany
Novartis Investigative Site
Dresden, Saxony, Germany
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Brescia, BS, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Kashiwa, Chiba, Japan
Novartis Investigative Site
Osaka, Osaka, Japan
Novartis Investigative Site
Chuo Ku, Tokyo, Japan
Novartis Investigative Site
Koto Ku, Tokyo, Japan
Novartis Investigative Site
Amsterdam, Netherlands
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Málaga, Spain
Novartis Investigative Site
Valencia, Spain
Novartis Investigative Site
Taipei, Taiwan