Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05358249 | Recruiting | KRAS G12C Mutant Solid Tumors

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

Novartis Pharmaceuticals

Brief Summary:

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 or disease

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

Intervention/treatment

JDQ443

trametinib

Ribociclib

cetuximab

Phase

Phase 1

Phase 2

Detailed Description:

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.}}

Study Type : Interventional
Estimated Enrollment : 346 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : 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
Actual Study Start Date : October 24, 2022
Estimated Primary Completion Date : May 5, 2027
Estimated Study Completion Date : June 16, 2027
Arm Intervention/treatment

Experimental: JDQ443+trametinib

JDQ443 in combination with trametinib

Drug: JDQ443

Drug: trametinib

Experimental: JDQ443+ribociclib

JDQ443 in combination with ribociclib

Drug: JDQ443

Drug: Ribociclib

Experimental: JDQ443+cetuximab

JDQ443 in combination with cetuximab

Drug: JDQ443

Biological: cetuximab
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

Location Details

Please Choose a site

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

United States, Massachusetts

Massachusetts General Hospital .

Boston, Massachusetts, United States, 02114

Recruiting

United States, Massachusetts

Dana Farber Cancer Institute Dept.of DFCI

Boston, Massachusetts, United States, 02215

Recruiting

United States, New York

NYU School of Medicine Langone Health

New York, New York, United States, 10015

Recruiting

Belgium, MI

Novartis Investigative Site

Leuven, MI, Belgium, 3000

Recruiting

France, Catalonia

Novartis Investigative Site

Bordeaux, Catalonia, France, 33076

Recruiting

France,

Novartis Investigative Site

Lyon, France, 69373

Recruiting

Germany,

Novartis Investigative Site

Freiburg, Germany, 79106

Recruiting

Germany,

Novartis Investigative Site

Ulm, Germany, 89081

Recruiting

Italy,

Novartis Investigative Site

Milano, Italy, 20162

Recruiting

Korea, Republic of,

Novartis Investigative Site

Seoul, Korea, Republic of, 03080

Recruiting

Singapore,

Novartis Investigative Site

Singapore, Singapore, 168583

Recruiting

Spain,

Novartis Investigative Site

Barcelona, Spain, 08036

Recruiting

Spain,

Novartis Investigative Site

Madrid, Spain, 28034

Recruiting

Spain,

Novartis Investigative Site

Madrid, Spain, 28050