Active Not RecruitingPhase 1 / Phase 2NCT05358249

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

This is 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.

Checked against the public recordLast updated Jun 15, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 1 / Phase 2
U.S. locations13
SponsorNovartis Pharmaceuticals
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

Inclusion 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. Exclusion 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/exclusion criteria may apply

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
  • Novartis Investigative SiteBarcelona
  • Novartis Investigative SiteMadrid

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 15, 2026. Always confirm current availability with the study team.

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