Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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
  4. advanced pancreatic cancer
  5. advanced triple negative breast cancer,
  6. 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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BLZ945 single agent
  • Drug: BLZ945
Experimental
BLZ945 + PDR001
  • Drug: BLZ945
  • Drug: PDR001

Recruiting Locations

Novartis Investigative Site
San Antonio, Texas 78229
Contact:
Kathleen Rodriguez
210-450-3838
rodriguezk3@uthscsa.edu

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
Novartis.email@novartis.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.