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

NCT ID: NCT04699188

Last Updated: 2025-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

344 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-24

Study Completion Date

2026-08-26

Brief Summary

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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.

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Detailed Description

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Conditions

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

JDQ443

Group Type EXPERIMENTAL

JDQ443

Intervention Type DRUG

KRAS G12C inhibitor

Arm B

JDQ443 in combination with TNO155

Group Type EXPERIMENTAL

JDQ443

Intervention Type DRUG

KRAS G12C inhibitor

TNO155

Intervention Type DRUG

SHP2 inhibitor

Arm C

JDQ443 in combination with tislelizumab

Group Type EXPERIMENTAL

JDQ443

Intervention Type DRUG

KRAS G12C inhibitor

tislelizumab

Intervention Type BIOLOGICAL

Anti PD1 antibody

Arm D

JDQ443 in combination with TNO155 and tislelizumab

Group Type EXPERIMENTAL

JDQ443

Intervention Type DRUG

KRAS G12C inhibitor

TNO155

Intervention Type DRUG

SHP2 inhibitor

tislelizumab

Intervention Type BIOLOGICAL

Anti PD1 antibody

Interventions

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JDQ443

KRAS G12C inhibitor

Intervention Type DRUG

TNO155

SHP2 inhibitor

Intervention Type DRUG

tislelizumab

Anti PD1 antibody

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Emory University School of Medicine-Winship Cancer Institute

Atlanta, Georgia, United States

Site Status

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status

Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Uni Of TX MD Anderson Cancer Cntr

Houston, Texas, United States

Site Status

Novartis Investigative Site

Melbourne, Victoria, Australia

Site Status

Novartis Investigative Site

Leuven, , Belgium

Site Status

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status

Novartis Investigative Site

Guangzhou, Guangdong, China

Site Status

Novartis Investigative Site

Beijing, , China

Site Status

Novartis Investigative Site

Copenhagen, , Denmark

Site Status

Novartis Investigative Site

Lyon, , France

Site Status

Novartis Investigative Site

Marseille, , France

Site Status

Novartis Investigative Site

Villejuif, , France

Site Status

Novartis Investigative Site

Cologne, , Germany

Site Status

Novartis Investigative Site

Dresden, , Germany

Site Status

Novartis Investigative Site

Essen, , Germany

Site Status

Novartis Investigative Site

Freiburg im Breisgau, , Germany

Site Status

Novartis Investigative Site

Hong Kong, , Hong Kong

Site Status

Novartis Investigative Site

Brescia, BS, Italy

Site Status

Novartis Investigative Site

Milan, MI, Italy

Site Status

Novartis Investigative Site

Milan, MI, Italy

Site Status

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Kashiwa, Chiba, Japan

Site Status

Novartis Investigative Site

Osaka, Osaka, Japan

Site Status

Novartis Investigative Site

Chuo Ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Koto Ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Amsterdam, , Netherlands

Site Status

Novartis Investigative Site

Singapore, , Singapore

Site Status

Novartis Investigative Site

Singapore, , Singapore

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Málaga, Andalusia, Spain

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

L'Hospitalet de Llobregat, Catalonia, Spain

Site Status

Novartis Investigative Site

Santiago de Compostela, Galicia, Spain

Site Status

Novartis Investigative Site

Valencia, Valencia, Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Taipei, , Taiwan

Site Status

Countries

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United States Australia Belgium Canada China Denmark France Germany Hong Kong Italy Japan Netherlands Singapore South Korea Spain Taiwan

References

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Lorthiois E, Gerspacher M, Beyer KS, Vaupel A, Leblanc C, Stringer R, Weiss A, Wilcken R, Guthy DA, Lingel A, Bomio-Confaglia C, Machauer R, Rigollier P, Ottl J, Arz D, Bernet P, Desjonqueres G, Dussauge S, Kazic-Legueux M, Lozac'h MA, Mura C, Sorge M, Todorov M, Warin N, Zink F, Voshol H, Zecri FJ, Sedrani RC, Ostermann N, Brachmann SM, Cotesta S. JDQ443, a Structurally Novel, Pyrazole-Based, Covalent Inhibitor of KRASG12C for the Treatment of Solid Tumors. J Med Chem. 2022 Dec 22;65(24):16173-16203. doi: 10.1021/acs.jmedchem.2c01438. Epub 2022 Nov 18.

Reference Type DERIVED
PMID: 36399068 (View on PubMed)

Other Identifiers

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2020-004129-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CJDQ443A12101

Identifier Type: -

Identifier Source: org_study_id

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