A Phase Ib/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation (KontRASt-01)

  • End date
    Aug 21, 2024
  • participants needed
  • sponsor
    Novartis Pharmaceuticals
Updated on 22 October 2022
measurable disease
solid tumor


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.

Condition 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
Treatment TNO155, spartalizumab, tislelizumab, JDQ443
Clinical Study IdentifierNCT04699188
SponsorNovartis Pharmaceuticals
Last Modified on22 October 2022


Yes No Not Sure

Inclusion Criteria

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 therapies
ECOG 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

Exclusion Criteria

Clinically significant cardiac disease or risk factors at screening
Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations
Symptomatic brain metastases or known leptomeningeal disease
A medical condition that results in increased photosensitivity Other protocol-defined inclusion/exclusion criteria may apply
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