Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
NCT ID: NCT05358249
Last Updated: 2025-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
74 participants
INTERVENTIONAL
2022-10-24
2026-05-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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JDQ443+trametinib
JDQ443 in combination with trametinib
JDQ443
KRAS G12C inhibitor, oral
trametinib
MEK inhibitor, oral
JDQ443+ribociclib
JDQ443 in combination with ribociclib
JDQ443
KRAS G12C inhibitor, oral
Ribociclib
CDK4/6 inhibitor, oral
JDQ443+cetuximab
JDQ443 in combination with cetuximab
JDQ443
KRAS G12C inhibitor, oral
cetuximab
EGFR inhibitor, intravenous
Interventions
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JDQ443
KRAS G12C inhibitor, oral
trametinib
MEK inhibitor, oral
Ribociclib
CDK4/6 inhibitor, oral
cetuximab
EGFR inhibitor, intravenous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
\- 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
* 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
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
NYU School of Medicine
New York, New York, United States
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Bordeaux, , France
Novartis Investigative Site
Lyon, , France
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Countries
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Other Identifiers
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2021-006196-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CJDQ443E12101
Identifier Type: -
Identifier Source: org_study_id
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