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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02829723
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Novartis Pharmaceuticals
Principal Investigator Affiliation Novartis Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Terminated
Countries Israel, Italy, Japan, Singapore, Spain, Switzerland, Taiwan, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Advanced Solid Tumors
Additional Details

This study was a first in human, open-label, multi-center phase I/II study which consisted of a phase I dose escalation part of BLZ945 as single agent, and of BLZ945 in combination with PDR001, where alternative dosing regimens of BLZ945 were evaluated. The escalation was guided by a Bayesian logistic regression model with overdose control. Once the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) for BLZ945 as single agent was established, a phase II part could commence, should signs of antitumor activity had been seen during the phase

  • I. Once the MTD/RP2D for BLZ945 in combination with PDR001 was established, a phase II part could commence.
Phase I part of the study involved patients with advanced solid tumors, including patients with recurrent glioblastoma and patients with Hodgkin's lymphoma, and phase II part patients with relapsed or refractory glioblastoma. A separate Japanese single agent dose escalation was performed in order to ensure that the safety and pharmacokinetic profiles of BLZ945 single agent were adequately characterized in Japanese patients. The Japanese dose escalation for BLZ945 single agent run separately from the ongoing global dose escalation. No Japanese patients were enrolled in phase II part according to protocol. The enrollment of the Japanese cohort was halted per investigator letter, dated 18-Jun-2021.

Arms & Interventions

Arms

Experimental: BLZ945 single agent

BLZ945 administered as single agent

Experimental: BLZ945 + PDR001

BLZ945 administered in combination with PDR001

Interventions

Drug: - BLZ945

BLZ945 administered orally as a capsule. Up to five alternative dosing schedules were evaluated: once per day (QD) 7 days on/7 days off (i.e., administer BLZ945 for 7 days and suspend for 7 days), QD 4 days on/10 days off, twice per day (BID) 4 days on/10 days off, once weekly (Q1W) QD and Q1W BID. Each cycle consisted of 28 days.

Drug: - PDR001

PDR001 400 mg administered via intravenous (i.v.) infusion every 4 weeks (Q4W)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Boston, Massachusetts

Status

Address

Dana Farber Cancer Institute Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Nashville, Tennessee

Status

Address

Sarah Cannon Research Institute Sarah Cannon Research

Nashville, Tennessee, 37203

UT M.D Anderson Cancer Center, Houston, Texas

Status

Address

UT M.D Anderson Cancer Center

Houston, Texas, 77030

Mays Cancer Ctr Uthsa Mdacc, San Antonio, Texas

Status

Address

Mays Cancer Ctr Uthsa Mdacc

San Antonio, Texas, 78229

International Sites

Novartis Investigative Site, Tel Aviv, Israel

Status

Address

Novartis Investigative Site

Tel Aviv, , 6423906

Novartis Investigative Site, Rozzano, MI, Italy

Status

Address

Novartis Investigative Site

Rozzano, MI, 20089

Novartis Investigative Site, Nagoya, Aichi, Japan

Status

Address

Novartis Investigative Site

Nagoya, Aichi, 466 8560

Novartis Investigative Site, Koto ku, Tokyo, Japan

Status

Address

Novartis Investigative Site

Koto ku, Tokyo, 135 8550

Novartis Investigative Site, Singapore, Singapore

Status

Address

Novartis Investigative Site

Singapore, , 168583

Novartis Investigative Site, Barcelona, Catalunya, Spain

Status

Address

Novartis Investigative Site

Barcelona, Catalunya, 08035

Novartis Investigative Site, Hospitalet de LLobregat, Catalunya, Spain

Status

Address

Novartis Investigative Site

Hospitalet de LLobregat, Catalunya, 08907

Novartis Investigative Site, Madrid, Spain

Status

Address

Novartis Investigative Site

Madrid, , 28041

Novartis Investigative Site, Zurich, Switzerland

Status

Address

Novartis Investigative Site

Zurich, , 8091

Novartis Investigative Site, Taipei, Taiwan

Status

Address

Novartis Investigative Site

Taipei, , 10002

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