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

Last updated: March 7, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Lung Cancer

Carcinoma

Non-small Cell Lung Cancer

Treatment

JDQ443

tislelizumab

TNO155

Clinical Study ID

NCT04699188
CJDQ443A12101
2020-004129-22
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solidtumors who have received standard of care or are intolerant or ineligible toapproved 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 ofcombinations and a subset of groups in dose expansion

Exclusion

Exclusion Criteria:

  • Tumors harboring driver mutations that have approved targeted therapies, with theexception of KRAS G12C mutations

  • Symptomatic brain metastases or known leptomeningeal disease. Patients withasymptomatic 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 Otherprotocol-defined inclusion/exclusion criteria may apply.

Study Design

Total Participants: 344
Treatment Group(s): 3
Primary Treatment: JDQ443
Phase: 1/2
Study Start date:
February 24, 2021
Estimated Completion Date:
August 26, 2026

Connect with a study center

  • Novartis Investigative Site

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • Novartis Investigative Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Montreal, Quebec H2W 1T8
    Canada

    Site Not Available

  • Novartis Investigative Site

    Fuzhou, Fujian 350014
    China

    Site Not Available

  • Novartis Investigative Site

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Novartis Investigative Site

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Novartis Investigative Site

    Beijing, 100036
    China

    Site Not Available

  • Novartis Investigative Site

    Copenhagen, DK-2100
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Lyon, 69373
    France

    Site Not Available

  • Novartis Investigative Site

    Lyon Cedex, 69373
    France

    Site Not Available

  • Novartis Investigative Site

    Marseille, 13273
    France

    Site Not Available

  • Novartis Investigative Site

    Villejuif, 94800
    France

    Site Not Available

  • Novartis Investigative Site

    Villejuif Cedex, 94800
    France

    Site Not Available

  • Novartis Investigative Site

    Dresden, 01307
    Germany

    Site Not Available

  • Novartis Investigative Site

    Essen, 45147
    Germany

    Site Not Available

  • Novartis Investigative Site

    Freiburg, 79106
    Germany

    Site Not Available

  • Novartis Investigative Site

    Koeln, 50937
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hong Kong, 999077
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Brescia, BS 25123
    Italy

    Site Not Available

  • Novartis Investigative Site

    Milano, MI 20133
    Italy

    Site Not Available

  • Novartis Investigative Site

    Nagoya, Aichi 466 8560
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kashiwa, Chiba 277 8577
    Japan

    Site Not Available

  • Novartis Investigative Site

    Yokohama-city, Kanagawa 241-8515
    Japan

    Site Not Available

  • Novartis Investigative Site

    Osaka-city, Osaka 541-8567
    Japan

    Site Not Available

  • Novartis Investigative Site

    Chuo ku, Tokyo 104 0045
    Japan

    Site Not Available

  • Novartis Investigative Site

    Koto ku, Tokyo 135 8550
    Japan

    Site Not Available

  • Novartis Investigative Site

    Osaka, 545-8586
    Japan

    Site Not Available

  • Novartis Investigative Site

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Amsterdam, 1066 CX
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Zoetermeer, NL-2722 EP
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Singapore, 119074
    Singapore

    Site Not Available

  • Novartis Investigative Site

    Malaga, Andalucia 29010
    Spain

    Site Not Available

  • Novartis Investigative Site

    Barcelona, Catalunya 08035
    Spain

    Site Not Available

  • Novartis Investigative Site

    Hospitalet de LLobregat, Catalunya 08907
    Spain

    Site Not Available

  • Novartis Investigative Site

    Valencia, Comunidad Valenciana 46010
    Spain

    Site Not Available

  • Novartis Investigative Site

    Santiago De Compostela, Galicia 15706
    Spain

    Site Not Available

  • Novartis Investigative Site

    Madrid, 28050
    Spain

    Site Not Available

  • Novartis Investigative Site

    Tainan, 70403
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    Taipei, 10002
    Taiwan

    Site Not Available

  • Emory Univ Winship Cancer Inst Winship Cancer Center

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Emory University School of Medicine-Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Emory University School of Medicine-Winship Cancer Institute Winship Cancer Center

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Emory University School of Medicine/Winship Cancer Institute G2304 - C2301

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Emory University School of Medicine/Winship Cancer Institute Winship Cancer Center

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • WA Uni School Of Med .

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington Uni School of Med .

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School .

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine .

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Providence Cancer Center

    Portland, Oregon 97213
    United States

    Site Not Available

  • Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Uni Of TX MD Anderson Cancer Cntr

    Houston, Texas 77030
    United States

    Site Not Available

  • Uni Of TX MD Anderson Cancer Cntr Dept of MD Anderson CancerCent

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Uni of TX MD Anderson Cancer Cntr Dept of MD Anderson CancerCent

    Houston, Texas 77030
    United States

    Active - Recruiting

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