Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
About the study
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 tislelizumab) in advanced solid tumor patients. After the determination of the maximum tolerated dose / recommended dose for a particular treatment arm, dose expansion will assess the anti-tumor activity and further assess the safety, tolerability, and PK/PD of each regimen at the maximum tolerated dose / recommended dose or lower dose.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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 CRITERIA
Exclusion Criteria:
- 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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Carcinoma, Non-Small-Cell Lung,KRAS G12C Mutant Solid Tumors,Carcinoma, Colorectal,Cancer of Lung,Cancer of the Lung,Lung Cancer,Neoplasms, Lung,Neoplasms, Pulmonary,Pulmonary Cancer,Pulmonary Neoplasms
Age (in years)
18+
Phase
Phase 1/Phase 2
Participants needed
475
Est. Completion Date
Jan 8, 2027
Treatment type
Interventional
Sponsor
Novartis
ClinicalTrials.gov identifier
NCT04699188
Study number
CJDQ443A12101
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