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

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

Detailed Description
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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.

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

Conditions
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Neoplasms

Intervention / Treatment
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* Drug: LM716


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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: LJM716<br> | Drug: LM716<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dose-limiting toxicities (DLTs) in the dose escalation part |  | First cycle (28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CLJM716,, Japanese patients,, Neoplasms