Study Description
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.
Interventions
JDQ443
tislelizumab
TNO155
Eligibility 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:
- 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.
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