JDQ443 for Cancer

(KontRASt-01 Trial)

Recruiting at 51 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Novartis Pharmaceuticals

Disqualifiers: Brain metastases, Cardiac disease, Photosensitivity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

344 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug, JDQ443, alone and with two other drugs, in patients with advanced solid tumors. It aims to find the safest dose and see if the combination can effectively reduce tumors.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Eligibility Criteria

This trial is for adults with advanced solid tumors that have a specific mutation called KRAS G12C. They should have tried standard treatments or be unable to take them, and may have had previous KRAS G12C inhibitor treatment. Participants need at least one tumor that can be measured and must be fairly active and able to care for themselves.

Inclusion Criteria

You have at least one specific type of visible abnormality that can be measured according to a specific set of guidelines.

I may have been treated with a KRAS G12C inhibitor before.

I have advanced cancer with a KRAS G12C mutation and can't take standard treatments.

Exclusion Criteria

My tumor has a specific mutation, but not the KRAS G12C mutation.

Other protocol-defined inclusion/exclusion criteria may apply.

I have brain metastases but do not have symptoms, or they are treated.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Characterize the safety and tolerability of JDQ443 single agent and in combination with other treatments

21 days

1 cycle

Dose Expansion

Assess anti-tumor activity and further assess safety, tolerability, and PK/PD of each regimen

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• JDQ443

Trial Overview The study is testing the safety and effectiveness of JDQ443 alone, and in combination with TNO155 or tislelizumab, in patients with certain advanced cancers. It's an early-phase trial where doses are increased until they find the highest dose people can tolerate without severe side effects.

Participant Groups

Group I: Arm D Experimental Treatment 3 Interventions

JDQ443 in combination with TNO155 and tislelizumab

Group II: Arm C Experimental Treatment 2 Interventions

JDQ443 in combination with tislelizumab

Group III: Arm B Experimental Treatment 2 Interventions

JDQ443 in combination with TNO155

Group IV: Arm A Experimental Treatment 1 Intervention

JDQ443

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