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

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

ClinicalTrials.gov Identifier: NCT04237649

Novartis Reference Number: CKAZ954A12101

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Solid Tumors
Phase 
Phase 1
Overall status 
Recruiting
Enrollment count 
145 participants
Start date 
Feb 20, 2020
Completion date 
Aug 12, 2024
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
KAZ954
KAZ954 will be administered in every arm.
Drug
PDR001
KAZ954 + PDR001
Drug
NIR178
KAZ954 + NIR178
Drug
NZV930
KAZ954 + NZV930

Eligibility Criteria

Inclusion Criteria:

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. -

Exclusion Criteria:

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.

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Study Locations

United States
Northwestern University Medical School
Recruiting
Chicago, 60611
Illinois
United States
Washington University School of Medicine Dept. of Siteman Cancer Center
Recruiting
Saint Louis, 63110
Missouri
United States
Japan
Novartis Investigative Site
Recruiting
Sunto Gun, 411 8777
Shizuoka
Japan
Singapore
Novartis Investigative Site
Recruiting
Singapore, 119074
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Singapore

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]