KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors
Stopped early · Early Phase 1
Conditions studied: Solid Tumors
In brief
The primary objective of the trial was to characterize the safety, tolerability, and maximum tolerated dose (MTD)/recommended dose (RD) for expansion of single agent KAZ954 and KAZ954 in combination with PDR001, NIR178 and NZV930.
Key facts
- Study ID
- NCT04237649
- Run by
- Novartis Pharmaceuticals
- People needed
- 77
- Starts
- 2020-02-20
- Expected to finish
- 2023-09-15
- Last updated by the study team
- 2025-05-18
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify 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.
Where it is running
- University Of California LA — Los Angeles, California, United States
- Yale University Yale Cancer Center — New Haven, Connecticut, United States
- Northwestern University Med School — Chicago, Illinois, United States
- WA Uni School Of Med Dept. of Siteman Cancer Center — St Louis, Missouri, United States
- Uni of TX MD Anderson Cancer Cntr — Houston, Texas, United States
- Novartis Investigative Site — Toronto, Ontario, Canada
- Novartis Investigative Site — Shatin New Territories, Hong Kong, Hong Kong
- Novartis Investigative Site — Milan, MI, Italy
- Novartis Investigative Site — Milan, MI, Italy
- Novartis Investigative Site — Sunto Gun, Shizuoka, Japan
- Novartis Investigative Site — Singapore, Singapore
- Novartis Investigative Site — Barcelona, Catalonia, Spain
- Novartis Investigative Site — Taipei, Taiwan
Full record on ClinicalTrials.gov
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