GP2013 in Japanese Patients With CD20 Positive Low Tumor Burden Indolent B-cell Non-Hodgkin's Lymphoma

Study Overview
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Brief Summary
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The purpose of this study is to evaluate safety and pharmacokinetic of GP2013 in Japanese patients with CD20 positive low tumor burden indolent B-cell NHL under weekly dosing schedule.

Official Title
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Phase I Trial to Assess the Safety and Pharmacokinetics of GP2013 Monotherapy Administered Weekly in Japanese Patients With CD20 Positive Low Tumor Burden Indolent B-cell Non-Hodgkin's Lymphoma

Conditions
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Indolent B-cell Non-Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: GP2013


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with CD20 positive low tumor burden indolent B-cell non- Hodgkin's lymphoma. Patient with at least one measurable lesion. Patient with ECOG performance status 0 or 1. Exclusion Criteria: Patient who has received radiotherapy within the last 28 days prior to administration, or are not recovered from previous radiotherapy. Patient who has received immunotherapy, chemotherapy, antibodies and experimental treatment within the last 28 days prior to administration, or are not recovered from previous therapy. Patient who has mAb therapy other than rituximab as prior line of therapy. Patient with evidence of any uncontrolled, acute or chronic active infection (viral, bacterial or fungal). Patient with any other malignancy within 5 years prior to date of screening, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or nonmelanomatous skin cancer. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GP2013<br> | Drug: GP2013<br>* GP2013<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate safety of GP2013 | Adverse events, laboratory abnormalities | 12 weeks | 
| Area under the curve calculated from start of dose to the end of the dosing interval (tau) of GP2013 |  | 12 weeks | 
| Maximum observed concentration of GP2013 |  | 12 weeks | 
| Time to reach maximum concentration of GP2013 |  | 12 weeks | 
| Minimum (trough) observed concentration during each dosing interval of GP2013 |  | 12 weeks | 
| Terminal elimination rate constant calculated as the slope of the linear regression of the terminal phase of the logarithmic concentration-time profile of GP2013 |  | 12 weeks | 
| Elimination half-life associated with the terminal slope of GP2013 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate efficacy of GP2013 | Antitumor activity | 12 weeks | 
| To evaluate the incidence of immunogenicity (ADA formation) against GP2013 | Immunogenicity (ADA formation) | 12 weeks | 
| To evaluate peripheral CD19+ B-cell count | CD19 + B-cell count | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GP2013, Japanese, indolent B-cell non-Hodgkin's lymphoma, biosimilar, CD20, GP13-101