Last Update: Oct 08, 2024
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
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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
or lower dose.

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
Phase1, Phase2
Recruiting
475
Feb 24, 2021
Jan 08, 2027
All
18 Years - (Adult, Older Adult)

Interventions

Drug

JDQ443

KRAS G12C inhibitor
Biological

tislelizumab

Anti PD1 antibody
Drug

TNO155

SHP2 inhibitor

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 and a subset of groups in dose expansion

Exclusion Criteria:

- Tumors harboring driver mutations that have approved targeted therapies, with the
exception of KRAS G12C mutations

- Symptomatic brain metastases or known leptomeningeal disease. Patients with
asymptomatic 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 Other
protocol-defined inclusion/exclusion criteria may apply.

Study Location

Novartis Investigative Site

Recruiting

Melbourne,Victoria,3000,Australia

Novartis Investigative Site

Recruiting

Leuven,3000,Belgium

Novartis Investigative Site

Recruiting

Montreal,Quebec,H2w 1t8,Canada

Novartis Investigative Site

Recruiting

Nanchang,Jiangxi,330006,China

Novartis Investigative Site

Recruiting

Beijing,100036,China

Novartis Investigative Site

Recruiting

Fuzhou,Fujian,350014,China

Novartis Investigative Site

Recruiting

Guangzhou,Guangdong,510080,China

Novartis Investigative Site

Recruiting

Copenhagen,Dk-2100,Denmark

Novartis Investigative Site

Recruiting

Lyon,69373,France

Novartis Investigative Site

Recruiting

Marseille,13273,France

Novartis Investigative Site

Recruiting

Villejuif,94800,France

Novartis Investigative Site

Recruiting

Dresden,01307,Germany

Novartis Investigative Site

Recruiting

Essen,45147,Germany

Novartis Investigative Site

Recruiting

Koeln,50937,Germany

Novartis Investigative Site

Recruiting

Freiburg,79106,Germany

Novartis Investigative Site

Recruiting

Hong Kong,Hong Kong

Novartis Investigative Site

Recruiting

Milano,MI,20162,Italy

Novartis Investigative Site

Recruiting

Brescia,BS,25123,Italy

Novartis Investigative Site

Recruiting

Chuo ku,Tokyo,104 0045,Japan

Novartis Investigative Site

Recruiting

Nagoya,Aichi,466 8560,Japan

Novartis Investigative Site

Recruiting

Kashiwa,Chiba,277 8577,Japan

Novartis Investigative Site

Recruiting

Osaka-city,Osaka,541-8567,Japan

Novartis Investigative Site

Recruiting

Koto ku,Tokyo,135 8550,Japan

Novartis Investigative Site

Recruiting

Seoul,03722,Korea, Republic of

Novartis Investigative Site

Recruiting

Zoetermeer,Nl-2722 ep,Netherlands

Novartis Investigative Site

Recruiting

Singapore,168583,Singapore

Novartis Investigative Site

Recruiting

Singapore,119074,Singapore

Novartis Investigative Site

Recruiting

Madrid,28050,Spain

Novartis Investigative Site

Recruiting

Hospitalet de LLobregat,Catalunya,08907,Spain

Novartis Investigative Site

Recruiting

Malaga,Andalucia,29010,Spain

Novartis Investigative Site

Recruiting

Barcelona,Catalunya,08035,Spain

Novartis Investigative Site

Recruiting

Valencia,Comunidad Valenciana,46010,Spain

Novartis Investigative Site

Recruiting

Santiago De Compostela,Galicia,15706,Spain

Novartis Investigative Site

Recruiting

Tainan,70403,Taiwan

Novartis Investigative Site

Recruiting

Taipei,10002,Taiwan

Providence Cancer Center

Recruiting

Portland,Oregon,97213,United States

Rachel Sanborn
Teresa Song
503-215-2691

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

Recruiting

Atlanta,Georgia,30322,United States

Obi Okafor
Conor E. Steuer

Massachusetts General Hospital Cancer Center

Recruiting

Boston,Massachusetts,02114,United States

Rebecca Heist
Rebecca Heist

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

Recruiting

Houston,Texas,77030,United States

Marcelo Vailati Negrao
Shari A Daniels
+1 713 745 3039

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