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NCT02740270 Clinical Trial

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

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02740270
Other study ID # CGWN323X2101
Secondary ID 2015-004206-42
Status Completed
Phase Phase 1
First received
Last updated
Start date July 22, 2016
Est. completion date March 3, 2020

Study information
Verified date February 2021
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 92
Est. completion date March 3, 2020
Est. primary completion date March 3, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• GWN323

• PDR001

Locations
Country Name City State
Canada Novartis Investigative Site Toronto Ontario
Israel Novartis Investigative Site Tel Aviv
Japan Novartis Investigative Site Kashiwa Chiba
Singapore Novartis Investigative Site Singapore
Spain Novartis Investigative Site Barcelona Catalunya
United States Novartis Investigative Site Boston Massachusetts
United States Novartis Investigative Site Chicago Illinois
United States Novartis Investigative Site Houston Texas
United States Novartis Investigative Site New York New York

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Israel,  Japan,  Singapore,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Dose Limiting Toxicities (DLTs) - Single Agent Dose Limiting Toxicities 21 days
Primary Incidence of Dose Limiting Toxicities (DLTs) - Combination Agents Dose Limiting Toxicities 42 days
Secondary Best Overall Response (BOR), 36 months
Secondary Progression Free Survival (PFS) per irRC and RECIST v1.1 or Cheson (2014) 36 months
Secondary Serum concentration profiles of GWN323 as a single agent: Cmax 36 months
Secondary Serum concentration profiles of GWN323 in combination with PDR001 and derived PK parameters: Cmax 36 months
Secondary Presence and titer of anti-GWN323 antibodies 36 months
Secondary Measurement of the effector/regulatory T cell ratio at screening, 36 months
Secondary Serum concentration profiles of GWN323 as a single agent: AUC 36 months
Secondary Serum concentration profiles of GWN323 in combination with PDR001 and derived PK parameters: AUC 36 months
Secondary Presence and titer of anti-PDR001 antibodies 36 months
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