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Trial record 1 of 1 for:    NCT04699188
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Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

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ClinicalTrials.gov Identifier: NCT04699188
Recruitment Status : Recruiting
First Posted : January 7, 2021
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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 spartalizumab) 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 or disease Intervention/treatment Phase
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 Drug: JDQ443 Drug: TNO155 Biological: spartalizumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 345 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 24, 2021
Estimated Primary Completion Date : August 21, 2024
Estimated Study Completion Date : August 21, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A
JDQ443
Drug: JDQ443
KRAS G12C inhibitor

Experimental: Arm B
JDQ443 in combination with TNO155
Drug: JDQ443
KRAS G12C inhibitor

Drug: TNO155
SHP2 inhibitor

Experimental: Arm C
JDQ443 in combination with spartalizumab
Drug: JDQ443
KRAS G12C inhibitor

Biological: spartalizumab
Anti PD1 antibody

Experimental: Arm D
JDQ443 in combination with TNO155 and spartalizumab
Drug: JDQ443
KRAS G12C inhibitor

Drug: TNO155
SHP2 inhibitor

Biological: spartalizumab
Anti PD1 antibody




Primary Outcome Measures :
  1. Dose Escalation: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment [ Time Frame: 18 months ]
  2. Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 24 months ]
  3. Dose Escalation: Frequency of dose interruptions and reductions, by treatment [ Time Frame: 24 months ]
  4. Dose Escalation: Dose intensity by treatment [ Time Frame: 24 months ]
  5. Dose Expansion: Overall response rate (ORR) per RECIST v1.1, by treatment [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Dose Escalation and Expansion: ORR per RECIST v1.1 [ Time Frame: 24 months ]
  2. Dose Escalation and Expansion: Best Overall Response (BOR) per RECIST v1.1 [ Time Frame: 24 months ]
  3. Dose Escalation and Expansion: Progression-free survival (PFS) per RECIST v1.1, Overall Survival (OS) [ Time Frame: 24 months ]
  4. Dose Escalation and Expansion: Duration of Response (DOR) per RECIST v1.1 [ Time Frame: 24 months ]
  5. Dose Escalation and Expansion: Disease Control Rate (DCR) per RECIST v1.1 [ Time Frame: 24 months ]
  6. Dose Escalation and Expansion: Plasma or serum concentration vs time profiles (AUC) by treatment [ Time Frame: 18 months ]
  7. Dose Escalation and Expansion: Plasma concentration (Cmax) by treatment [ Time Frame: 18 months ]
  8. Dose Escalation and Expansion: Time to achieve Cmax (Tmax) by treatment [ Time Frame: 18 months ]
  9. Dose Escalation and Expansion: Antidrug antibody (ADA) incidence by treatment [ Time Frame: 24 months ]
  10. Dose Expansion: Frequency of dose interruptions and reductions, by treatment [ Time Frame: 24 months ]
  11. Dose Expansion: Dose intensity by treatment [ Time Frame: 24 months ]
  12. Dose Expansion: Incidence and severity of AEs and SAEs by treatment [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors
  • Prior treatment with a KRAS G12C inhibitor may be allowed for dose escalations of combinations

Exclusion Criteria:

  • Tumors harboring driver mutations that have approved therapies or tumors with known activating KRAS, NRAS, HRAS, BRAF or PTPN11 (SHP2) mutations, with exception of KRAS G12C mutations
  • Active brain metastases
  • Clinically significant cardiac disease or risk factors at screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04699188


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, Georgia
Emory University School of Medicine/Winship Cancer Institute Winship Cancer Center Recruiting
Atlanta, Georgia, United States, 30322
Contact: Akilah Harris    404-778-5714    Akilah.harris@emory.edu   
Principal Investigator: Conor Steuer         
United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Rebecca Heist       rheist@partners.org   
Principal Investigator: Rebecca Heist         
Australia, Victoria
Novartis Investigative Site Recruiting
Melbourne, Victoria, Australia, 3000
Belgium
Novartis Investigative Site Recruiting
Leuven, Belgium, 3000
Canada, Quebec
Novartis Investigative Site Recruiting
Montreal, Quebec, Canada, H2W 1T8
China, Guangdong
Novartis Investigative Site Recruiting
Guangzhou, Guangdong, China, 51000
Denmark
Novartis Investigative Site Recruiting
Copenhagen, Denmark, DK-2100
France
Novartis Investigative Site Recruiting
Lyon Cedex, France, 69373
Novartis Investigative Site Recruiting
Villejuif Cedex, France, 94800
Germany
Novartis Investigative Site Recruiting
Dresden, Germany, 01307
Novartis Investigative Site Recruiting
Essen, Germany, 45147
Novartis Investigative Site Recruiting
Koeln, Germany, 50937
Hong Kong
Novartis Investigative Site Recruiting
Hong Kong, Hong Kong
Japan
Novartis Investigative Site Recruiting
Chuo ku, Tokyo, Japan, 104 0045
Netherlands
Novartis Investigative Site Recruiting
Amsterdam, Netherlands, 1066 CX
Singapore
Novartis Investigative Site Recruiting
Singapore, Singapore, 119074
Novartis Investigative Site Recruiting
Singapore, Singapore, 169610
Spain
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Recruiting
Madrid, Spain, 28050
Taiwan
Novartis Investigative Site Recruiting
Taipei, Taiwan, 10002
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04699188    
Other Study ID Numbers: CJDQ443A12101
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
KRAS
KRAS G12C
Metastatic cancer
Advanced cancer
Enzyme inhibitor
PD-1
SHP2
Targeted therapy
Non-small-cell lung cancer
colorectal cancer
Molecular mechanisms of pharmacological action
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Spartalizumab
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents