Status:
ACTIVE_NOT_RECRUITING
Study of JDQ443 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 a phase Ib/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and t...
Eligibility Criteria
Inclusion
- Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care or are intolerant or ineligible to approved therapies
- ECOG Performance Status of 0 or 1
- At least one measurable lesion as defined by RECIST 1.1
- Prior treatment with a KRAS G12C inhibitor may be allowed for dose escalations of combinations and a subset of groups in dose expansion
Exclusion
- Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations
- Symptomatic brain metastases or known leptomeningeal disease. Patients with asymptomatic treated or untreated brain metastases may be eligible
- Clinically significant cardiac disease or risk factors at screening
- A medical condition that results in increased photosensitivity Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2026
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT04699188
Start Date
February 24 2021
End Date
August 26 2026
Last Update
June 22 2025
Active Locations (37)
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1
Emory University School of Medicine-Winship Cancer Institute
Atlanta, Georgia, United States, 30322
2
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
3
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
4
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas, United States, 77030