NCT02740270

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2016

Typical duration for phase_1

Geographic Reach
6 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

July 22, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2020

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

3.6 years

First QC Date

April 5, 2016

Last Update Submit

February 18, 2021

Conditions

Solid TumorsLymphomas

Keywords

advanced solid tumorslymphomasGWN323PDR001advanced malignanciesanti-GITRanti-PD-1adults

Outcome Measures

Primary Outcomes (2)

  • Incidence of Dose Limiting Toxicities (DLTs) - Single Agent

    Dose Limiting Toxicities

    21 days

  • Incidence of Dose Limiting Toxicities (DLTs) - Combination Agents

    Dose Limiting Toxicities

    42 days

Secondary Outcomes (9)

  • Best Overall Response (BOR),

    36 months

  • Progression Free Survival (PFS)

    36 months

  • Serum concentration profiles of GWN323 as a single agent: Cmax

    36 months

  • Serum concentration profiles of GWN323 in combination with PDR001 and derived PK parameters: Cmax

    36 months

  • Presence and titer of anti-GWN323 antibodies

    36 months

  • +4 more secondary outcomes

Study Arms (2)

Arm A

EXPERIMENTAL
Drug: GWN323

Arm B

EXPERIMENTAL
Drug: GWN323Drug: PDR001

Interventions

GWN323DRUG
Arm AArm B
PDR001DRUG
Arm B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Novartis Investigative Site

Chicago, Illinois, 60637, United States

Location

Novartis Investigative Site

Boston, Massachusetts, 02215, United States

Location

Novartis Investigative Site

New York, New York, 10017, United States

Location

Novartis Investigative Site

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

Tel Aviv, 6423906, Israel

Location

Novartis Investigative Site

Kashiwa, Chiba, 277 8577, Japan

Location

Novartis Investigative Site

Singapore, 169610, Singapore

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Related Publications (1)

  • Piha-Paul SA, Geva R, Tan TJ, Lim DW, Hierro C, Doi T, Rahma O, Lesokhin A, Luke JJ, Otero J, Nardi L, Singh A, Xyrafas A, Chen X, Mataraza J, Bedard PL. First-in-human phase I/Ib open-label dose-escalation study of GWN323 (anti-GITR) as a single agent and in combination with spartalizumab (anti-PD-1) in patients with advanced solid tumors and lymphomas. J Immunother Cancer. 2021 Aug;9(8):e002863. doi: 10.1136/jitc-2021-002863.

    PMID: 34389618DERIVED

Related Links

MeSH Terms

Conditions

Lymphoma

Interventions

spartalizumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 15, 2016

Study Start

July 22, 2016

Primary Completion

March 3, 2020

Study Completion

March 3, 2020

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)ES(1)CA(1)SG(1)US(4)JP(1)