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Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

# NCT04699188 Trial phase: 1, 2 Study type: Any

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

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
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