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

NCT04699188

Active Not RecruitingPhase 1, Phase 2

Sponsor: Novartis Pharmaceuticals

Conditions: KRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small-Cell Lung, Carcinoma, Colorectal, Cancer of Lung, Cancer of the Lung

Interventions: JDQ443, TNO155, tislelizumab

Countries: United States, Australia, Belgium, Canada, China, Denmark, France, Germany

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 overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (38)
  • Atlanta, Georgia, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Pittsburgh, Pennsylvania, United States
  • Houston, Texas, United States
  • Melbourne, Victoria, Australia
  • Leuven, Belgium
  • Montreal, Quebec, Canada
  • Guangzhou, Guangdong, China
  • Beijing, China
  • Copenhagen, Denmark
  • Lyon, France
  • Marseille, France
  • Villejuif, France
  • Freiburg im Breisgau, Baden-Wurttemberg, Germany
  • Cologne, North Rhine-Westphalia, Germany
  • Dresden, Saxony, Germany
  • Essen, Germany
  • Hong Kong, Hong Kong
  • Brescia, BS, Italy
  • Milan, MI, Italy
  • Milan, MI, Italy
  • Nagoya, Aichi-ken, Japan
  • Kashiwa, Chiba, Japan
  • Osaka, Osaka, Japan
  • Chuo Ku, Tokyo, Japan
  • Koto Ku, Tokyo, Japan
  • Amsterdam, Netherlands
  • Singapore, Singapore
  • Singapore, Singapore
  • + 8 more on CT.gov