Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
- Trial number:
- NCT04699188
- Trial phase:
- 1, 2
- Study type:
- Targeted therapy, Biomarker
- Overall status:
- Recruiting
Study start date
February, 2021
Scientific 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
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.
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 therapiesECOG 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
Study design
Primary purpose:
Treatment, Allocation:
Non-Randomized, Intervention model:
Parallel Assignment, Masking:
None (Open Label),
Conditions
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
Other study ID numbers
CJDQ443A12101; 2020-004129-22
Choose trial site (53)
Emory University School of Medicine/Winship Cancer Institute
1365 Clifton Rd Building C, Atlanta, GA 30322, USA
Massachusetts General Hospital Cancer Center
55 Fruit St, Boston, MA 02114, USA
Novartis Investigative Site
104-0045, Japan
Novartis Investigative Site
Melbourne VIC 3000, Australia
Novartis Investigative Site
3000 Leuven, Belgium
Novartis Investigative Site
Lyon, France
Novartis
20 Pasir Panjang Rd, #10-25/28 Mapletree Business City, Singapore 117439
Novartis Investigative Site
94800 Villejuif, France
Novartis Investigative Site
89, Hullenbergweg 81, 1101 CL Amsterdam, Netherlands
National Cancer Centre Singapore
Novartis Investigative Site
01307 Dresden, Germany
Novartis Investigative Site
45147 Essen, Germany
Novartis Investigative Site
Subbelrather Str. 186, 50823 Köln, Germany
Novartis Investigative Site
Hong Kong, Quarry Bay, 富通中心
National University Hospital 119074
20 Pasir Panjang Rd, #10-25/28 Mapletree Business City, Singapore 117439
Novartis Investigative Site
Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain
Novartis Investigative Site
C. de Serrano Galvache, 56, 28033 Madrid, Spain
Emory University School of Medicine/Winship Cancer Institute Winship Cancer Center
1365 E Clifton Rd NE Building C, Atlanta, GA 30322, USA
Novartis Investigative Site
Montreal, QC H2W 1T8, Canada
Novartis Investigative Site
Guangzhou, Guangdong Province, China
Novartis Investigative Site
KLP II, Edvard Thomsens Vej 14, 3. sal, 2300 København, Denmark
Novartis Investigative Site
Taipei City, Taiwan
University of Texas MD Anderson Cancer Center Dept of MD Anderson CancerCent
1515 Holcombe Blvd, Houston, TX 77030, USA
Novartis Investigative Site
Haidian District, China, 100036
Novartis Investigative Site
79106 Freiburg im Breisgau, Germany
Novartis Investigative Site
Via Tortona, 30, 20144 Milano MI, Italy
Novartis Investigative Site
Via Tortona, 30, 20144 Milano MI, Italy
Novartis Investigative Site
135-8550, Japan
Novartis Investigative Site
Seoul, South Korea
Washington University School of Medicine
660 S Euclid Ave, St. Louis, MO 63110, USA
Novartis Investigative Site
241-8515, Japan
Novartis Investigative Site
545-8586, Japan
Providence Cancer Center
NE Glisan St, Portland, OR 97213, USA
Novartis Investigative Site
466-8560, Japan
Hillman Cancer Center
5115 Centre Ave, Pittsburgh, PA 15232, USA
Novartis Investigative Site
46010 Valencia, Spain
Washington University School of Medicine .
660 S Euclid Ave, St. Louis, MO 63110, USA
Uni of TX MD Anderson Cancer Cntr Dept of MD Anderson CancerCent
1515 Holcombe Blvd, Houston, TX 77030, USA
Novartis Investigative Site
Lyon, France
Novartis Investigative Site
Singapore
Washington University School .
4547 Clayton Ave, St. Louis, MO 63110, USA
Novartis Investigative Site
541-8567, Japan
Novartis Investigative Site
08907 L'Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative Site
277-8577, Japan
Novartis Investigative Site
94800 Villejuif, France
Emory University School of Medicine/Winship Cancer Institute G2304 - C2301
1365 Clifton Rd NE Building C, Atlanta, GA 30322, USA
Washington Uni School of Med .
1 Barnes Jewish Hospital Plaza, St. Louis, MO 63110, USA
Novartis Investigative Site
Donghu District, Nanchang, China, 330006
Novartis Investigative Site
Marseille, France
Novartis Investigative Site
29010 Málaga, Spain
Novartis Investigative Site
Santiago de Compostela, 15706 Municipality of Santiago de Compostela, A Coruña, Spain
Novartis Investigative Site
Tainan, East District, Tainan City, Taiwan
Novartis Investigative Site
25123 Brescia, Province of Brescia, Italy