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

KontRASt-03: A Phase Ib/II, Multicenter, Open-label Platform Study of JDQ443 With Select Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

ClinicalTrials.gov Identifier: NCT05358249

Novartis Reference Number: CJDQ443E12101

Last Update: Nov 15, 2022

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This is Phase Ib/II, multicenter, open-label adaptive platform study of JDQ443 with select therapies in patients with advanced solid tumors harboring the KRAS G12C mutation.

Condition 
KRAS G12C Mutant Solid Tumors
Carcinoma, Non-Small Cell Lung
Carcinoma, Non-Small-Cell Lung
Non-Small Cell Lung Cancer
Non-Small Cell Lung Carcinoma
Nonsmall Cell Lung Cancer
Colorectal Cancer
Colorectal Carcinoma
Colorectal Neoplasms
Colorectal Tumors
Neoplasms, Colorectal
Phase 
Phase 1
Phase 2
Overall status 
Recruiting
Start date 
Oct 24, 2022
Completion date 
Aug 06, 2025
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
JDQ443
KRAS G12C inhibitor, oral
Drug
trametinib
MEK inhibitor, oral
Drug
Ribociclib
CDK4/6 inhibitor, oral
Biological
cetuximab
EGFR inhibitor, intravenous

Eligibility Criteria

Inclusion Criteria:

Dose Escalation:

- Patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care therapy or are ineligible to receive such therapy.

Phase II:

Patients with advanced (metastatic or unresectable) KRAS G12C mutant non-small cell lung cancer who have received platinum-based chemotherapy regimen and immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy
Patients with advanced (metastatic or unresectable) KRAS G12C mutant colorectal cancer who have received fluropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, unless patient was ineligible to such therapy.

All patients:

ECOG performance status of 0 or 1.
Patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines.

Exclusion Criteria:

Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations
Prior treatment with a KRAS G12C inhibitor is excluded for patients in a subset of groups in Phase II.
Active brain metastases, including symptomatic brain metastases or known leptomeningeal disease
Clinically significant cardiac disease or risk factors at screening
Insufficient bone marrow, hepatic or renal function at screening Other protocol-defined inclusion/exclusion criteria may apply

Study Locations

Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03080
-
Korea, Republic of

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]