We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified November 2017 by Novartis ( Novartis Pharmaceuticals )
Sponsor:
ClinicalTrials.gov Identifier:
NCT02740270
First Posted: April 15, 2016
Last Update Posted: November 17, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
April 5, 2016
April 15, 2016
November 17, 2017
July 22, 2016
May 3, 2019   (Final data collection date for primary outcome measure)
  • Incidence of Dose Limiting Toxicities (DLTs) - Single Agent [ Time Frame: 21 days ]
    Dose Limiting Toxicities
  • Incidence of Dose Limiting Toxicities (DLTs) - Combination Agents [ Time Frame: 42 days ]
    Dose Limiting Toxicities
Same as current
Complete list of historical versions of study NCT02740270 on ClinicalTrials.gov Archive Site
  • Best Overall Response (BOR), [ Time Frame: 36 months ]
  • Progression Free Survival (PFS) [ Time Frame: 36 months ]
    per irRC and RECIST v1.1 or Cheson (2014)
  • Serum concentration profiles of GWN323 as a single agent: Cmax [ Time Frame: 36 months ]
  • Serum concentration profiles of GWN323 in combination with PDR001 and derived PK parameters: Cmax [ Time Frame: 36 months ]
  • Presence and titer of anti-GWN323 antibodies [ Time Frame: 36 months ]
  • Measurement of the effector/regulatory T cell ratio [ Time Frame: at screening, 36 months ]
  • Serum concentration profiles of GWN323 as a single agent: AUC [ Time Frame: 36 months ]
  • Serum concentration profiles of GWN323 in combination with PDR001 and derived PK parameters: AUC [ Time Frame: 36 months ]
  • Presence and titer of anti-PDR001 antibodies [ Time Frame: 36 months ]
Same as current
Not Provided
Not Provided
 
Phase I/Ib Study of GWN323 Alone and in Combination With PDR001 in Patients With Advanced Malignancies and Lymphomas
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Solid Tumors
  • Lymphomas
  • Drug: GWN323
  • Drug: PDR001
  • Experimental: Arm A
    Intervention: Drug: GWN323
  • Experimental: Arm B
    Interventions:
    • Drug: GWN323
    • Drug: PDR001
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
264
May 3, 2019
May 3, 2019   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Novartis Pharmaceuticals 1-888-669-6682 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111
Canada,   Israel,   Singapore,   Spain,   United States
 
 
NCT02740270
CGWN323X2101
2015-004206-42 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP