Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
- Trial number:
-
NCT04699188
- Trial phase:
- 1, 2
- Study type:
- Targeted therapy, Biomarker
- Overall status:
- Recruiting
Study start date
February, 2021
Scientific title
A Phase Ib/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
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 spartalizumab) 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.
Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumorsPrior treatment with a KRAS G12C inhibitor may be allowed for dose escalations of combinations
Tumors harboring driver mutations that have approved therapies or tumors with known activating KRAS, NRAS, HRAS, BRAF or PTPN11 (SHP2) mutations, with exception of KRAS G12C mutationsActive brain metastases Clinically significant cardiac disease or risk factors at screening
Study design
Primary purpose:
Treatment,
Allocation:
Non-Randomized,
Intervention model:
Sequential Assignment,
Masking:
None (Open Label),
Conditions
KRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small-Cell Lung, Carcinoma, Colorectal, Cancer of Lung, Cancer of the Lung, Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary, Pulmonary Cancer, Pulmonary Neoplasms
Other study ID numbers
CJDQ443A12101
Choose trial site (33)
Novartis
Recruiting
20 Pasir Panjang Rd, #10-25/28 Mapletree Business City, Singapore 117439
National Cancer Centre Singapore
Recruiting
National University Hospital 119074
Recruiting
Singapore 119074