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

February 18, 2021 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Novartis Investigative Site
  • Israel
      • Tel Aviv, Israel, 6423906
        • Novartis Investigative Site
  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan, 277 8577
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 169610
        • Novartis Investigative Site
  • Spain
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Novartis Investigative Site
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Novartis Investigative Site
    • New York
      • New York, New York, United States, 10017
        • Novartis Investigative Site
    • Texas
      • Houston, Texas, United States, 77030
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Drug: GWN323
Experimental: Arm B
Drug: PDR001
Drug: GWN323

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Dose Limiting Toxicities (DLTs) - Single Agent
Time Frame: 21 days
Dose Limiting Toxicities
21 days
Incidence of Dose Limiting Toxicities (DLTs) - Combination Agents
Time Frame: 42 days
Dose Limiting Toxicities
42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence and titer of anti-PDR001 antibodies
Time Frame: 36 months
36 months
Best Overall Response (BOR),
Time Frame: 36 months
36 months
Progression Free Survival (PFS)
Time Frame: 36 months
per irRC and RECIST v1.1 or Cheson (2014)
36 months
Serum concentration profiles of GWN323 as a single agent: Cmax
Time Frame: 36 months
36 months
Serum concentration profiles of GWN323 in combination with PDR001 and derived PK parameters: Cmax
Time Frame: 36 months
36 months
Presence and titer of anti-GWN323 antibodies
Time Frame: 36 months
36 months
Measurement of the effector/regulatory T cell ratio
Time Frame: at screening, 36 months
at screening, 36 months
Serum concentration profiles of GWN323 as a single agent: AUC
Time Frame: 36 months
36 months
Serum concentration profiles of GWN323 in combination with PDR001 and derived PK parameters: AUC
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2016

Primary Completion (Actual)

March 3, 2020

Study Completion (Actual)

March 3, 2020

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 11, 2016

First Posted (Estimate)

April 15, 2016

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGWN323X2101
  • 2015-004206-42 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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