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OpenTrials
Completed

NCT Number: NCT02740270

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

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Key information

Conditions

Solid Tumors Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphomas Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GWN323

Drug

PDR001

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 15, 2016
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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