Back to resultsA Phase I Study of LJM716 in Squamous Cell Carcinoma of Head and Neck, or HER2+ Breast Cancer or Gastric Cancer
Primary Purpose
HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, HER2 + Breast Cancer, HER2 + Gastric Cancer
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LJM716
Sponsored by
About this trial
This is an interventional treatment trial for HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma focused on measuring Breast cancer, gastric cancer, squamous cell carcinoma of head and neck, esophageal squamous cell carcinoma, Breast cancer, Gastric cancer, Squamous cell carcinoma of head and neck, Esophageal squamous cell carcinoma
Eligibility Criteria
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
Sites / Locations
- University of Chicago Medical Center University of Chicago (16)
- Massachusetts General Hospital SC-5
- University of Texas/MD Anderson Cancer Center UT MD
- University of Utah / Huntsman Cancer Institute Huntsman
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dose escalation and dose expansion
Arm Description
Outcomes
Primary Outcome Measures
Dose-limiting toxicities (DLTs)
Secondary Outcome Measures
Adverse events
Serious adverse events
Pharmacodynamic response to LJM716 in tumor tissue
Frequency of partial responses, complete responses and stable disease according to RECIST
Serum concentration of antibodies to LJM716
Progression-free survival
Duration of response
Serum concentration of LJM716,
Full Information
NCT ID
NCT01598077
First Posted
May 4, 2012
Last Updated
December 16, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01598077
Brief Title
A Phase I Study of LJM716 in Squamous Cell Carcinoma of Head and Neck, or HER2+ Breast Cancer or Gastric Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma
Keywords
Breast cancer, gastric cancer, squamous cell carcinoma of head and neck, esophageal squamous cell carcinoma, Breast cancer, Gastric cancer, Squamous cell carcinoma of head and neck, Esophageal squamous cell carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose escalation and dose expansion
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
LJM716
Primary Outcome Measure Information:
Title
Dose-limiting toxicities (DLTs)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
4 months
Title
Serious adverse events
Time Frame
4 months
Title
Pharmacodynamic response to LJM716 in tumor tissue
Time Frame
3 months
Title
Frequency of partial responses, complete responses and stable disease according to RECIST
Time Frame
every 2 months
Title
Serum concentration of antibodies to LJM716
Time Frame
18 months
Title
Progression-free survival
Time Frame
18 months
Title
Duration of response
Time Frame
18 months
Title
Serum concentration of LJM716,
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of Chicago Medical Center University of Chicago (16)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60546
Country
United States
Facility Name
Massachusetts General Hospital SC-5
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Texas/MD Anderson Cancer Center UT MD
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
University of Utah / Huntsman Cancer Institute Huntsman
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
110 744
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
28899363
Citation
Reynolds KL, Bedard PL, Lee SH, Lin CC, Tabernero J, Alsina M, Cohen E, Baselga J, Blumenschein G Jr, Graham DM, Garrido-Laguna I, Juric D, Sharma S, Salgia R, Seroutou A, Tian X, Fernandez R, Morozov A, Sheng Q, Ramkumar T, Zubel A, Bang YJ. A phase I open-label dose-escalation study of the anti-HER3 monoclonal antibody LJM716 in patients with advanced squamous cell carcinoma of the esophagus or head and neck and HER2-overexpressing breast or gastric cancer. BMC Cancer. 2017 Sep 12;17(1):646. doi: 10.1186/s12885-017-3641-6.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=13604
Description
Results for CLJM716X2101 can be found on the Novartis Clinical Trial Results Website
Learn more about this trial
A Phase I Study of LJM716 in Squamous Cell Carcinoma of Head and Neck, or HER2+ Breast Cancer or Gastric Cancer
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