TerminatedPhase 1 / Phase 2NCT05358249
Official study title

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

Study summary

This was Phase Ib/II, multicenter, open-label adaptive platform study of JDQ443 with select therapies in patients with advanced solid tumors harboring the KRAS G12C mutation.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedJDQ443 and trametinib

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 21, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?13 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: trametinib; Drug: Ribociclib; Biological: cetuximab
02
Explore related studies

How this study is categorized

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

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
  • Dose Escalation: \- Patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care therapy or are ineligible to receive such therapy. Phase II:
  • Patients with advanced (metastatic or unresectable) KRAS G12C mutant non-small cell lung cancer who have received platinum-based chemotherapy regimen and immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy
  • Patients with advanced (metastatic or unresectable) KRAS G12C mutant colorectal cancer who have received fluropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, unless patient was ineligible to such therapy. All patients:
  • ECOG performance status of 0 or 1.
  • Patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines.
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
  • Prior treatment with a KRAS G12C inhibitor is excluded for patients in a subset of groups in Phase II.
  • Active brain metastases, including symptomatic brain metastases or known leptomeningeal disease
  • Clinically significant cardiac disease or risk factors at screening
  • Insufficient bone marrow, hepatic or renal function at screening 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

  • Massachusetts General HospitalBoston, Massachusetts
  • Dana Farber Cancer InstituteBoston, Massachusetts
  • NYU School of MedicineNew York, New York
  • Novartis Investigative SiteLeuven
  • Novartis Investigative SiteBordeaux
  • Novartis Investigative SiteLyon
  • Novartis Investigative SiteFreiburg im Breisgau, Baden-Wurttemberg
  • Novartis Investigative SiteMilan, MI
  • Novartis Investigative SiteSingapore
  • Novartis Investigative SiteSeoul, Seoul
  • Novartis Investigative SiteBarcelona
  • Novartis Investigative SiteMadrid

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 21, 2026. Always confirm current availability with the study team.

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