A Phase I Study of LJM716 in Squamous Cell Carcinoma of Head and Neck, or HER2+ Breast Cancer or Gastric Cancer

December 16, 2020 updated by: Novartis Pharmaceuticals

A Phase I Study of LJM716 in Patients With Squamous Cell Carcinoma of Head and Neck, or HER2 Overexpressing Metastatic Breast Cancer or Gastric Cancer

This primary purpose of this study is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) and preferred dosing schedule of LJM716 given by IV infusion in adult patients with squamous cell carcinoma of head and neck, or esophagus, or HER2 overexpressing metastatic breast cancer or gastric cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

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
  • Korea, Republic of
    • Korea
      • Seoul, Korea, Korea, Republic of, 110 744
        • Novartis Investigative Site
  • Spain
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Novartis Investigative Site
  • Taiwan
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60546
        • University of Chicago Medical Center University of Chicago (16)
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital SC-5
    • Texas
      • Houston, Texas, United States, 77030-4009
        • University of Texas/MD Anderson Cancer Center UT MD
    • Utah
      • Salt Lake City, Utah, United States, 84103
        • University of Utah / Huntsman Cancer Institute Huntsman

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 HER2+ breast cancer, or HER2+ gastric cancer, or squamous cell carcinoma of head and neck, or esophageal squamous cell carcinoma
  • Site of disease that can be safely biopsied

Exclusion criteria:

  • Patients received prior anti-HER3 antibody treatment
  • Patients with impaired cardiac function
  • Brain metastases that have not been adequately treated
  • Malignant disease other than that being treated in this study
  • Pregnant or nursing (lactating) women
  • Laboratory abnormalities as specified in the protocol 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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dose escalation and dose expansion
Drug: LJM716

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose-limiting toxicities (DLTs)
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 18 months
18 months
Duration of response
Time Frame: 18 months
18 months
Adverse events
Time Frame: 4 months
4 months
Serious adverse events
Time Frame: 4 months
4 months
Pharmacodynamic response to LJM716 in tumor tissue
Time Frame: 3 months
3 months
Frequency of partial responses, complete responses and stable disease according to RECIST
Time Frame: every 2 months
every 2 months
Serum concentration of antibodies to LJM716
Time Frame: 18 months
18 months
Serum concentration of LJM716,
Time Frame: 4 months
4 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

July 1, 2012

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

May 4, 2012

First Submitted That Met QC Criteria

May 14, 2012

First Posted (ESTIMATE)

May 15, 2012

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLJM716X2101
  • 2011-004865-33 (EUDRACT_NUMBER)

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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