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

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: LM716

• Registration Number: NCT01911936
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2013-07-24
• Study First Submitted QC: 2013-07-27
• Study First Posted: 2013-07-30
• Study Start: 2013-09
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-05
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. 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

2. ECOG Performance Status of 0-2

3. 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.

4. Willingness and ability to comply with all study procedures

5. Written informed consent obtained prior to any screening procedures

6. During dose expansion part of the study, patients must have at least one measurable lesion as defined by RECIST v1.1 criteria

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LJM716	LM716	-

Primary Outcome Measures

Name	Time	Method
Incidence of dose-limiting toxicities (DLTs) in the dose escalation part	First cycle (28 days)

Secondary Outcome Measures

Name	Time	Method
Tumor response according to RECIST 1.1	every 2 months until end of treatment up to 2 years
Incidence of antibodies against LJM716	up to 10 cycle ( 1cycle = 28 days)
Frequency and severity of adverse events, number of and reasons for	from informed consent till 30 days after end of treatment
LJM716 serum concentration-time- profile and estimated PK	up to 10 cycle (1 cycle = 28 days)

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Fukuoka, Japan