Phase I/II Study of BLZ945 Single Agent or BLZ945 in Combination With PDR001 in Advanced Solid Tumors



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/14/2018
Start Date:October 21, 2016
End Date:June 19, 2019
Contact:Novartis Pharmaceuticals
Email:Novartis.email@novartis.com
Phone:1-888-669-6682

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A Phase I/II, Open-label, Multi-center Study of the Safety and Efficacy of BLZ945 as Single Agent and in Combination With PDR001 in Adults Patients With Advanced Solid Tumors

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, patients will be enrolled in the phase II part in the selected
indications (glioblastoma, pancreatic cancer and triple negative breast cancer) to further
assess the preliminary anti-tumor activity of BLZ945 in combination with PDR001. Should signs
of anti-tumor activity be seen in the phase I dose escalation with BLZ945 as single agent, a
phase II part will be opened in order to further explore BLZ945 single agent efficacy at the
recommended dose.


Inclusion Criteria:

1. 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

2. Phase I: Patients with a site of disease amenable to biopsy, and willing to undergo a
new tumor biopsy at screening, and during treatment.

3. Phase II: Patients with advanced/metastatic tumors in the below selected indications,
with at least one measurable lesion as determined by RECIST v1.1 or RANO

- advanced pancreatic cancer

- advanced triple negative breast cancer,

- recurrent glioblastoma

Other protocol defined inclusion criteria may apply

Exclusion Criteria:

1. History of severe hypersensitivity reactions to monoclonal antibodies.

2. Impaired cardiac function or clinically significant cardiac disease.

3. Active autoimmune disease or a documented history of autoimmune disease.

4. Systemic steroid therapy or any immunosuppressive therapy

5. Use of any vaccines against infectious diseases within 4 weeks of initiation of study
treatment.

6. 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.
We found this trial at
4
sites
Nashville, Tennessee 37205
Principal Investigator: Todd M. Bauer
Phone: 615-289-9227
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Houston, Texas 77030
Principal Investigator: Aung Naing
Phone: 713-563-9033
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Houston, TX
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Rozzano, MI 20089
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Rozzano,
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San Antonio, Texas 78207
Principal Investigator: John Sarantopoulos
Phone: 210-450-3838
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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