NCT01598077

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

Trial Health

93
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2012

Geographic Reach
5 countries

8 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

May 4, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

December 19, 2020

Status Verified

April 1, 2014

Enrollment Period

1.7 years

First QC Date

May 4, 2012

Last Update Submit

December 16, 2020

Conditions

HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell CarcinomaHER2 + Breast CancerHER2 + Gastric CancerSquamous Cell Carcinoma of Head and NeckEsophageal Squamous Cell Carcinoma

Keywords

Breast cancer, gastric cancer, squamous cell carcinoma of head and neck, esophageal squamous cell carcinomaBreast cancerGastric cancerSquamous cell carcinoma of head and neckEsophageal squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • Dose-limiting toxicities (DLTs)

    4 weeks

Secondary Outcomes (8)

  • Adverse events

    4 months

  • Serious adverse events

    4 months

  • Pharmacodynamic response to LJM716 in tumor tissue

    3 months

  • Frequency of partial responses, complete responses and stable disease according to RECIST

    every 2 months

  • Serum concentration of antibodies to LJM716

    18 months

  • +3 more secondary outcomes

Study Arms (1)

Dose escalation and dose expansion

EXPERIMENTAL
Drug: LJM716

Interventions

LJM716DRUG
Dose escalation and dose expansion

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Chicago Medical Center University of Chicago (16)

Chicago, Illinois, 60546, United States

Location

Massachusetts General Hospital SC-5

Boston, Massachusetts, 02114, United States

Location

University of Texas/MD Anderson Cancer Center UT MD

Houston, Texas, 77030-4009, United States

Location

University of Utah / Huntsman Cancer Institute Huntsman

Salt Lake City, Utah, 84103, United States

Location

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

Seoul, Korea, 110 744, South Korea

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Taipei, 10002, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 28899363DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsStomach NeoplasmsEsophageal Squamous Cell CarcinomaSquamous Cell Carcinoma of Head and Neck

Interventions

elgemtumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous CellEsophageal NeoplasmsHead and Neck NeoplasmsEsophageal 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

May 4, 2012

First Posted

May 15, 2012

Study Start

July 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

December 19, 2020

Record last verified: 2014-04

Locations

CA(1)TW(1)US(4)KR(1)ES(1)