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

  • STATUS
    Recruiting
  • End date
    Mar 17, 2022
  • participants needed
    200
  • sponsor
    Novartis Pharmaceuticals
Updated on 6 August 2021

Summary

The purpose of this first-in-human (FIH) study of BLZ945 given as a single agent or in combination with PDR001 is 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.

Dose escalation will be guided by a Bayesian logistic regression model with overdose control. Once MTD/ RP2D is declared, glioblastoma patients will be enrolled in the phase II part to further assess the preliminary anti-tumor activity of BLZ945 as single agent and in combination with PDR001.

Details
Condition Advanced Solid Tumors
Treatment PDR001, BLZ945
Clinical Study IdentifierNCT02829723
SponsorNovartis Pharmaceuticals
Last Modified on6 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Phase I: Patients with advanced/metastatic solid tumors, with measurable or unmeasurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
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
Other protocol defined inclusion criteria may apply

Exclusion Criteria

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
Other protocol defined exclusion criteria may apply
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