Status:
ACTIVE_NOT_RECRUITING
Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
KRAS G12C Mutant Solid Tumors
Carcinoma, Non-Small Cell Lung
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Detailed Description
JDQ443 will be considered "backbone" treatment in this trial and combined with selected therapies, or "partner(s)". The combination of a backbone and a partner will constitute a treatment arm. After d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2026
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT05358249
Start Date
October 24 2022
End Date
May 18 2026
Last Update
November 3 2025
Active Locations (13)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
3
NYU School of Medicine
New York, New York, United States, 10015
4
Novartis Investigative Site
Leuven, Belgium, 3000