Overview

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

Status:
Recruiting

Trial end date:
2024-08-21

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Novartis Pharmaceuticals

Treatments:

Spartalizumab

Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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