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 |
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.
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
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Houston, Texas 77030
Principal Investigator: Aung Naing
Phone: 713-563-9033
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Nashville, Tennessee 37205
Principal Investigator: Todd M. Bauer
Phone: 615-289-9227
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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