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Active Not RecruitingPhase 1 / Phase 2NCT04699188
Official study title

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

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedJDQ443 and TNO155

Plus 1 other study approaches.

Who it may be forKRAS

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 19, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?38 U.S. locations

Locations may change over time.

Who runs it?Novartis Pharmaceuticals

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Novartis Pharmaceuticals
Interventions being studied
Drug: JDQ443; Drug: TNO155; Biological: tislelizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Biomarkers
KRAS→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Emory University School of Medicine-Winship Cancer InstituteAtlanta, Georgia
  • Massachusetts General Hospital Cancer CenterBoston, Massachusetts
  • Massachusetts General HospitalBoston, Massachusetts
  • Hillman Cancer CenterPittsburgh, Pennsylvania
  • Uni Of TX MD Anderson Cancer CntrHouston, Texas
  • Novartis Investigative SiteMelbourne, Victoria
  • Novartis Investigative SiteLeuven
  • Novartis Investigative SiteMontreal, Quebec
  • Novartis Investigative SiteGuangzhou, Guangdong
  • Novartis Investigative SiteBeijing
  • Novartis Investigative SiteCopenhagen
  • Novartis Investigative SiteLyon

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 19, 2026. Always confirm current availability with the study team.

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