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
Last Update: Nov 22, 2021
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.
Interventions
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.
Study Locations
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]