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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01933516

Enrollment

Registered

2013-09-02

Start date

2013-05-31

Completion date

2014-08-31

Last updated

2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Indolent B-cell Non-Hodgkin's Lymphoma

Keywords

GP2013, Japanese, indolent B-cell non-Hodgkin's lymphoma, biosimilar, CD20, GP13-101

Brief summary

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.

Interventions

DRUGGP2013

GP2013

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame	Description
Elimination half-life associated with the terminal slope 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	—
To evaluate safety of GP2013	12 weeks	Adverse events, laboratory abnormalities
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	—

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026