KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors

Recruiting at 20 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Novartis Pharmaceuticals

Must not be taking: Corticosteroids

Disqualifiers: CNS metastases, Cardiac impairment, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

77 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called KAZ954 alone and with other drugs to find the safest and most effective dose for patients with advanced cancer. The goal is to see if these treatments can help patients who haven't responded to standard therapies.

Will I have to stop taking my current medications?

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

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

ECOG Performance Status of <2.

You have advanced cancer that cannot be treated with surgery to cure it.

Must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening and during the study.

Exclusion Criteria

You have experienced a severe allergic reaction to any ingredient in the study drug or similar medications.

There may be additional requirements or restrictions for participating in the study that are not listed here.

You have heart problems, HIV, a history of tuberculosis, or have been taking steroids for a long time.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

The dose escalation part estimated the MTD and/or RD and tested different dosing schedules.

Up to 52 weeks

Dose Expansion

Planned to use the MTD/RDE determined in the dose escalation part to assess the activity, safety, and tolerability of the investigational products.

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• KAZ954
• NIR178
• NZV930
• PDR001

Participant Groups

Group I: Arm D Experimental Treatment 2 Interventions

KAZ954 + NZV930

Group II: Arm C Experimental Treatment 2 Interventions

KAZ954 + NIR178

Group III: Arm B Experimental Treatment 2 Interventions

KAZ954 + PDR001

Group IV: Arm A Experimental Treatment 1 Intervention

KAZ954

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