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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT04699188

Run by

Novartis Pharmaceuticals

People needed

344

Starts

2021-02-24

Expected to finish

2027-01-25

Last updated by the study team

2026-03-18

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Emory University School of Medicine-Winship Cancer Institute — Atlanta, Georgia, United States
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Uni Of TX MD Anderson Cancer Cntr — Houston, Texas, United States
• Novartis Investigative Site — Melbourne, Victoria, Australia
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Guangzhou, Guangdong, China
• Novartis Investigative Site — Beijing, China
• Novartis Investigative Site — Copenhagen, Denmark
• Novartis Investigative Site — Lyon, France
• Novartis Investigative Site — Marseille, France
• Novartis Investigative Site — Villejuif, France
• Novartis Investigative Site — Freiburg im Breisgau, Baden-Wurttemberg, Germany
• Novartis Investigative Site — Cologne, North Rhine-Westphalia, Germany
• Novartis Investigative Site — Dresden, Saxony, Germany
• Novartis Investigative Site — Essen, Germany
• Novartis Investigative Site — Hong Kong, Hong Kong
• Novartis Investigative Site — Brescia, BS, Italy
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Nagoya, Aichi-ken, Japan
• Novartis Investigative Site — Kashiwa, Chiba, Japan
• Novartis Investigative Site — Osaka, Osaka, Japan

Full record on ClinicalTrials.gov

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