A Study of BLZ945 Single Agent or BLZ945 in Combination With PDR001 in Advanced Solid Tumors

Stopped early · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumors

In brief

The purpose of this first-in-human (FIH) study of BLZ945 given as a single agent or in combination with PDR001 was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of BLZ945, administered orally, as a single agent or in combination with PDR001, administered intravenously (i.v.) in adult patients with advanced solid tumors.

Key facts

Study ID

NCT02829723

Run by

Novartis Pharmaceuticals

People needed

192

Starts

2016-10-21

Expected to finish

2022-12-01

Last updated by the study team

2024-01-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Phase I: Patients with advanced/metastatic solid tumors including relapsed or refractory (r/r) glioblastoma and r/r lymphoma, with measurable or unmeasurable disease as determined by the respective response evaluation criteria.
• Phase I: Patients with a site of disease amenable to biopsy, and willing to undergo a new tumor biopsy at screening, and during treatment.
• Phase II: Patients with advanced/metastatic/recurrent isocitrate dehydrogenase (IDH) wild-type glioblastoma, with at least one measurable lesion as determined by RANO

You may not qualify if…

• History of severe hypersensitivity reactions to monoclonal antibodies.
• Impaired cardiac function or clinically significant cardiac disease.
• Active autoimmune disease or a documented history of autoimmune disease.
• Systemic steroid therapy or any immunosuppressive therapy
• Use of any vaccines against infectious diseases within 4 weeks of initiation of study treatment.
• Patient receiving treatment with medications that either strong inducers or inhibitors of CYP2C8 or CYP3A4/5, or patients receiving medication that prohibits proton pump inhibitors and that cannot be discontinued at least 1 week prior to start of treatment and for the duration of the study.
• Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery), or increasing doses of corticosteroids within the prior 2 weeks before start of study treatment (not applicable for glioblastoma).

Where it is running

• Dana Farber Cancer Institute Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Sarah Cannon Research Institute Sarah Cannon Research — Nashville, Tennessee, United States
• UT M.D Anderson Cancer Center — Houston, Texas, United States
• Mays Cancer Ctr Uthsa Mdacc — San Antonio, Texas, United States
• Novartis Investigative Site — Tel Aviv, Israel
• Novartis Investigative Site — Rozzano, MI, Italy
• Novartis Investigative Site — Nagoya, Aichi-ken, Japan
• Novartis Investigative Site — Koto Ku, Tokyo, Japan
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — L'Hospitalet de Llobregat, Catalonia, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Zurich, Switzerland
• Novartis Investigative Site — Taipei, Taiwan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.