Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
Running, not enrolling · Phase 1/Phase 2
Conditions studied: KRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small Cell Lung, Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma, Nonsmall Cell Lung Cancer, Colorectal Cancer, Colorectal Carcinoma, Colorectal Neoplasms, Colorectal Tumors, Neoplasms, Colorectal
In brief
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.
Key facts
- Study ID
- NCT05358249
- Run by
- Novartis Pharmaceuticals
- People needed
- 74
- Starts
- 2022-10-24
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2026-06-15
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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