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

Conditions

Esophageal Squamous Cell Carcinoma, HER2 + Breast Cancer, HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck

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

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

Reynolds KL, Bedard PL, Lee SH, Lin CC, Tabernero J, Alsina M, Cohen E, Baselga J, Blumenschein G, 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.

2017-09-1224 citations

10.1186/s12885-017-3641-6

LJM716 in Japanese patients with head and neck squamous cell carcinoma or HER2-overexpressing breast or gastric cancer.

Takahashi S, Kobayashi T, Tomomatsu J, Ito Y, Oda H, Kajitani T, Kakizume T, Tajima T, Takeuchi H, Maacke H, Esaki T.

2016-12-0911 citations

10.1007/s00280-016-3214-4

A phase 1 study of LJM716 in patients with esophageal squamous cell carcinoma, head and neck cancer, or HER2-overexpressing metastatic breast or gastric cancer.

Kerry L. Reynolds, Dejan Juric, José Baselga, María Alsina, Josep Tabernero et al. (19 authors)

Journal of Clinical Oncology2014-05-2015 citations

10.1200/jco.2014.32.15_suppl.2517

Interventions

DRUGLJM716

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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/

Design outcomes

Primary

Measure	Time frame
Dose-limiting toxicities (DLTs)	4 weeks

Secondary

Measure	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

Countries

Canada, South Korea, Spain, Taiwan, United States

Outcome results

None listed