A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors

Novartis

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Treatments

Drug: LM716

Study type

Interventional

Funder types

Industry

Identifiers

NCT01911936

CLJM716X1101

Details and patient eligibility

About

This study will evaluate safety and tolerability to estimate the MTDand/or recommended dose.

Full description

This is a phase I, open-label, dose-escalation study to establish the MTD and/or RDE of LJM716 as single agent in Japanese patients that have advanced solid tumors. The study consists of a dose escalation part and a dose expansion part.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Patients with the following indications:

i) (Dose escalation part only): HER2 overexpressing locally advanced/ metastatic breast cancer or gastric cancer for which no effective treatment option exists:
- For breast cancer: documented 3+ by immunohistochemistry, or amplification by in situ hybridization
- For gastric cancer (including GE junction tumors): documented 3+ by immunohistochemistry, or 2+ by immunohistochemistry and amplification by in situ hybridization OR, ii) (Dose escalation part only): Recurrent or metastatic SCCHN regardless of HER2 status for which no effective treatment option exists OR, iii) Recurrent or metastatic ESCC regardless of HER2 status for which no effective treatment option exists
ECOG Performance Status of 0-2
Must have recovered from the adverse effects of any prior surgery, radiotherapy or other antineoplastic therapy. Alopecia and CTCAE Grade 1 peripheral neuropathy is acceptable.
Willingness and ability to comply with all study procedures
Written informed consent obtained prior to any screening procedures
During dose expansion part of the study, patients must have at least one measurable lesion as defined by RECIST v1.1 criteria