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 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.

Inclusion Criteria:

1. 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.

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/recurrent isocitrate dehydrogenase (IDH)
wild-type glioblastoma, with at least one measurable lesion as determined by RANO

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.

7. 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).