Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

A Phase Ib/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

ClinicalTrials.gov Identifier: NCT04699188

Novartis Reference Number: CJDQ443A12101

Last Update: May 06, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

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.

Condition 
KRAS G12C Mutant Solid Tumors
Carcinoma, Non-Small-Cell Lung
Carcinoma, Colorectal
Cancer of Lung
Cancer of the Lung
Lung Cancer
Neoplasms, Lung
Neoplasms, Pulmonary
Pulmonary Cancer
Pulmonary Neoplasms
Phase 
Phase 1
Phase 2
Overall status 
Recruiting
Start date 
Feb 24, 2021
Completion date 
Aug 21, 2024
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
JDQ443
KRAS G12C inhibitor
Drug
TNO155
SHP2 inhibitor
Biological
tislelizumab
Anti PD1 antibody

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

Exclusion Criteria:

Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations
Active brain metastases
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 Locations

United States
Emory University School of Medicine/Winship Cancer Institute Winship Cancer Center
Recruiting
Atlanta, 30322 - Georgia
Contact: Akilah Harris (404-778-5714) - [email protected] - Conor E. Steuer
United States
Massachusetts General Hospital Cancer Center
Recruiting
Boston, 02114 - Massachusetts
Contact: Rebecca Heist - [email protected] - Rebecca Heist
United States
Washington University School of Medicine
Recruiting
Saint Louis, 63110 - Missouri
Contact: Casey Ezell - [email protected] - Ramaswamy Govindan
United States
University of Texas MD Anderson Cancer Center Dept of MD Anderson CancerCent
Recruiting
Houston, 77030 - Texas
Contact: Lauren McGuire (713-745-3039) - [email protected] - Marcelo V Negrao
United States
Australia
Novartis Investigative Site
Recruiting
Melbourne, 3000
Victoria
Australia
Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
Canada
Novartis Investigative Site
Recruiting
Montreal, H2W 1T8
Quebec
Canada
China
Novartis Investigative Site
Recruiting
Guangzhou, 51000
Guangdong
China
Novartis Investigative Site
Recruiting
Beijing, 100036
-
China
Denmark
Novartis Investigative Site
Recruiting
Copenhagen, DK-2100
-
Denmark
France
Novartis Investigative Site
Recruiting
Lyon Cedex, 69373
-
France
Novartis Investigative Site
Recruiting
Villejuif Cedex, 94800
-
France
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Essen, 45147
-
Germany
Novartis Investigative Site
Recruiting
Freiburg, 79106
-
Germany
Novartis Investigative Site
Recruiting
Koeln, 50937
-
Germany
Hong Kong
Novartis Investigative Site
Recruiting
Hong Kong,
-
Hong Kong
Italy
Novartis Investigative Site
Recruiting
Milano, 20133
MI
Italy
Novartis Investigative Site
Recruiting
Milano, 20162
MI
Italy
Japan
Novartis Investigative Site
Recruiting
Nagoya, 466 8560
Aichi
Japan
Novartis Investigative Site
Recruiting
Yokohama-city, 241-8515
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Chuo ku, 104 0045
Tokyo
Japan
Novartis Investigative Site
Recruiting
Koto ku, 135 8550
Tokyo
Japan
Novartis Investigative Site
Recruiting
Osaka, 545-8586
-
Japan
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03722
-
Korea, Republic of
Netherlands
Novartis Investigative Site
Recruiting
Amsterdam, 1066 CX
-
Netherlands
Singapore
Novartis Investigative Site
Recruiting
Singapore, 119074
-
Singapore
Novartis Investigative Site
Recruiting
Singapore, 169610
-
Singapore
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Madrid, 28050
-
Spain
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 10002
-
Taiwan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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Call 1-888-669-6682 or email [email protected]