Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
A Phase Ib/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
ClinicalTrials.gov Identifier: NCT04699188
Novartis Reference Number: CJDQ443A12101
Last Update: May 06, 2022
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
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.
Interventions
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
Exclusion Criteria:
Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations
Active brain metastases
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
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]