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. JDQ443 will be considered "backbone" treatment in this trial and combined with selected
therapies, or "partner(s)". The combination of a backbone and a partner will constitute a
treatment arm. After dose escalation, treatment arms that reach a maximum tolerated dose
/recommended dose and are determined to be safe may, but are not required to, proceed to
Phase II to further explore safety, tolerability, and anti-tumor activity.
Interventions
cetuximab
JDQ443
Ribociclib
trametinib
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 Location
Novartis Investigative Site
Recruiting
Leuven,3000,Belgium
Novartis Investigative Site
Recruiting
Bordeaux,33076,France
Novartis Investigative Site
Recruiting
Lyon,69373,France
Novartis Investigative Site
Recruiting
Freiburg,79106,Germany
Novartis Investigative Site
Recruiting
Ulm,89081,Germany
Novartis Investigative Site
Recruiting
Milano,MI,20162,Italy
Novartis Investigative Site
Recruiting
Seoul,03080,Korea, Republic of
Novartis Investigative Site
Recruiting
Singapore,168583,Singapore
Novartis Investigative Site
Recruiting
Madrid,28034,Spain
Novartis Investigative Site
Recruiting
Madrid,28050,Spain
Novartis Investigative Site
Recruiting
Barcelona,Catalunya,08036,Spain
Massachusetts General Hospital .
Recruiting
Boston,Massachusetts,02114,United States
Dana Farber Cancer Institute Dept.of DFCI
Recruiting
Boston,Massachusetts,02215,United States
NYU School of Medicine Langone Health
Recruiting
New York,New York,10015,United States
Worldwide Contacts
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