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

Study Overview
=================
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

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

Conditions
-----------------
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

Intervention / Treatment
-----------------
* Drug: LJM716


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose escalation and dose expansion<br> | Drug: LJM716<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Progression-free survival |  | 18 months | 
| Duration of response |  | 18 months | 
| Serum concentration of LJM716, |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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