JDQ443 Combinations for Advanced Cancer

(KontRASt-03 Trial)

Recruiting at15 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests JDQ443, a new drug, combined with other treatments for patients with advanced cancers having the KRAS G12C mutation. The drug aims to stop cancer growth by targeting a specific genetic fault.

Research Team

Eligibility Criteria

This trial is for adults with advanced solid tumors that have a specific mutation called KRAS G12C. It's open to those who've had standard treatments or can't receive them, and they should be able to undergo a tumor biopsy. People with poor organ function, active brain metastases, significant heart issues, or prior treatment with KRAS G12C inhibitors (in some cases) are excluded.

Inclusion Criteria

I have advanced colorectal cancer with a specific mutation and have been treated with certain chemotherapies.

I can have a biopsy based on my hospital's rules.

I have advanced lung cancer with a specific mutation and have had platinum chemotherapy and immunotherapy.

Exclusion Criteria

I have not taken a KRAS G12C inhibitor for my condition.

My liver, kidneys, or bone marrow are not working well.

I have active brain cancer spread.

Treatment Details

Interventions

• Cetuximab (Monoclonal Antibodies)
• JDQ443 (KRAS G12C Inhibitor)
• Ribociclib (CDK4/6 Inhibitor)
• Trametinib (MEK Inhibitor)

Trial Overview The study is testing JDQ443 in combination with other drugs like trametinib, ribociclib, and cetuximab on patients whose tumors have the KRAS G12C mutation. This adaptive platform study will adjust based on results as it progresses through phases Ib/II.

Participant Groups

Group I: JDQ443+trametinib Experimental Treatment 2 Interventions

JDQ443 in combination with trametinib

Group II: JDQ443+ribociclib Experimental Treatment 2 Interventions

JDQ443 in combination with ribociclib

Group III: JDQ443+cetuximab Experimental Treatment 2 Interventions

JDQ443 in combination with cetuximab

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD