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 tumors - Prior 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 mutations - Active 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

Carcinoma, Non-Small-Cell Lung, KRAS G12C Mutant Solid Tumors, Neoplasms, Lung, Lung Cancer, Cancer of Lung, Cancer of the Lung, Neoplasms, Pulmonary, Carcinoma, Colorectal, Pulmonary Neoplasms, Pulmonary Cancer

Other study ID numbers

CJDQ443A12101

Choose trial site (17)

Novartis
Novartis Recruiting
20 Pasir Panjang Rd, #10-25/28 Mapletree Business City, Singapore 117439
National Cancer Centre Singapore
National Cancer Centre Singapore Recruiting
National University Hospital 119074
National University Hospital 119074 Recruiting
Singapore 119074
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