Novartis

Key trial

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 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.

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 therapiesECOG 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

Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutationsSymptomatic 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 design

Primary purpose: Treatment, Allocation: Non-Randomized, Intervention model: Parallel 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; 2020-004129-22

Choose trial site (45)

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