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

a study on Solid Tumor Neoplasms

Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Zev A. Wainberg (ucla)

Description

Summary

The purpose of this trial is to explore the clinical utility of several therapies in patients with advanced cancer.

This is a multi-center, open-label Phase I/Ib study. The study consists of a dose escalation part, a dose expansion part testing KAZ954 as a single agent or KAZ954 in combination with PDR001, NZV930 and NIR178. The dose escalation parts will estimate the MTD and/or RD and test different dosing schedules.

The dose expansion parts of the study will use the MTD/RDE determined in the dose escalation part to assess the activity, safety and tolerability of the investigational products in patients with specific types of cancer.

Approximately 135 adult patients with advanced solid tumors will be enrolled.

Official Title

A Phase I/Ib, Open-label, Multi-center, Study of KAZ954 as a Single Agent and in Combination With Spartalizumab, NZV930 and NIR178 in Patients With Advanced Solid Tumors

Keywords

Solid Tumors, KAZ954, PDR001, Spartalizumab, NIR178, NZV930, Immunotherapy, Phase I/Ib, Neoplasms

Eligibility

You can join if…

Open to people ages 18-99

Patients with metastatic and/or advanced malignancies not amenable to curative treatment by surgery.

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.

ECOG Performance Status of <2.

You CAN'T join if...

Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require concurrent treatment - including surgery, radiation and/or corticosteroids.

History of severe hypersensitivity reaction to any ingredient of study drug(s) and other mAbs and/or their excipients.

Impaired cardiac function HIV Known history of tuberculosis Systemic chronic steroid therapy

Other protocol-defined inclusion/exclusion criteria may apply.

Locations

  • UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States
  • University of Texas MD Anderson Cancer Center accepting new patients
    Houston Texas 77030 United States

Lead Scientist at UC Cancer

  • Zev A. Wainberg (ucla)
    HS Clinical Professor, Medicine. Authored (or co-authored) 130 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT04237649
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 145 study participants
Last Updated