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Phase I/Ib Study of GWN323 Alone and in Combination With PDR001 in Patients With Advanced Malignancies and Lymphomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02740270
Recruitment Status : Completed
First Posted : April 15, 2016
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:

The purpose of this trial is to explore the clinical utility of two investigational antibodies in patients with advanced cancer or lymphomas.

This is a multi-center, open-label Phase I/Ib study. The study consists of two dose escalation parts and two dose expansion parts testing GWN323 as a single agent or GWN323 in combination with PDR001. The dose escalation parts will estimate the MTD and/or RDE and test different dosing schedules.

The dose expansion parts of the study will use the MTD/RDE determined in the dose escalation part to assess the activity, safety and tolerability of the investigational products in patients with specific types of cancer and lymphomas.

Approximately 264 adult patients with advanced solid tumors or lymphomas will be enrolled.


Condition or disease Intervention/treatment Phase
Solid Tumors Lymphomas Drug: GWN323 Drug: PDR001 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/Ib Open-label, Multi-center, Dose Escalation Study of GWN323 (Anti-GITR) as a Single Agent and in Combination With PDR001 (Anti-PD-1) in Patients With Advanced Solid Tumors and Lymphomas
Actual Study Start Date : July 22, 2016
Actual Primary Completion Date : March 3, 2020
Actual Study Completion Date : March 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A Drug: GWN323
Experimental: Arm B Drug: GWN323
Drug: PDR001


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Dose Limiting Toxicities (DLTs) - Single Agent [ Time Frame: 21 days ]
    Dose Limiting Toxicities

  2. Incidence of Dose Limiting Toxicities (DLTs) - Combination Agents [ Time Frame: 42 days ]
    Dose Limiting Toxicities


Secondary Outcome Measures :
  1. Best Overall Response (BOR), [ Time Frame: 36 months ]
  2. Progression Free Survival (PFS) [ Time Frame: 36 months ]
    per irRC and RECIST v1.1 or Cheson (2014)

  3. Serum concentration profiles of GWN323 as a single agent: Cmax [ Time Frame: 36 months ]
  4. Serum concentration profiles of GWN323 in combination with PDR001 and derived PK parameters: Cmax [ Time Frame: 36 months ]
  5. Presence and titer of anti-GWN323 antibodies [ Time Frame: 36 months ]
  6. Measurement of the effector/regulatory T cell ratio [ Time Frame: at screening, 36 months ]
  7. Serum concentration profiles of GWN323 as a single agent: AUC [ Time Frame: 36 months ]
  8. Serum concentration profiles of GWN323 in combination with PDR001 and derived PK parameters: AUC [ Time Frame: 36 months ]
  9. Presence and titer of anti-PDR001 antibodies [ Time Frame: 36 months ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with metastatic and/or advanced solid tumors or lymphomas not amenable to curative treatment by surgery.
  • Histologically documented advanced or metastatic solid tumors or lymphomas
  • Must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening
  • ECOG Performance Status ≤ 2.

Exclusion Criteria:

  • Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery).
  • Patients diagnosed with T-cell Lymphomas.
  • Patients with prior allogenic transplants.
  • Patients previously treated with anti-GITR therapy.
  • History of severe hypersensitivity reactions to other mAbs.
  • Patients intolerant to prior immunotherapy (unable to continue/receive due to immune-related AE).

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02740270


Locations
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United States, Illinois
Novartis Investigative Site
Chicago, Illinois, United States, 60637
United States, Massachusetts
Novartis Investigative Site
Boston, Massachusetts, United States, 02215
United States, New York
Novartis Investigative Site
New York, New York, United States, 10017
United States, Texas
Novartis Investigative Site
Houston, Texas, United States, 77030
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9
Israel
Novartis Investigative Site
Tel Aviv, Israel, 6423906
Japan
Novartis Investigative Site
Kashiwa, Chiba, Japan, 277 8577
Singapore
Novartis Investigative Site
Singapore, Singapore, 169610
Spain
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02740270    
Other Study ID Numbers: CGWN323X2101
2015-004206-42 ( EudraCT Number )
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
advanced solid tumors
lymphomas
GWN323
PDR001
 advanced malignancies
anti-GITR
anti-PD-1
adults
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Spartalizumab
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents