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radiolabeled epratuzumab

Phase 1

Non-Hodgkin's Lymphoma | Monoclonal antibody | Oncology |Gilead Sciences, Inc.|Trials Updated: Aug 19, 2021

radiolabeled epratuzumab development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2003

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

radiolabeled epratuzumab clinical trials

radiolabeled epratuzumab · 1 trial · 2 indications

Phase 1 1
NCT00061425Treatment of Non-Hodgkin's Lymphoma With 90Y-hLL2 IgGNon-Hodgkin's Lymphoma
COMPLETED- Analytics
PHASE1COMPLETED
Treatment of Non-Hodgkin's Lymphoma With 90Y-hLL2 IgG
Non-Hodgkin's LymphomaUnlock trial analytics

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
radiolabeled epratuzumabDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion: * Histological or cytological diagnosis of B-cell lymphoma, and has failed at least one regimen of standard chemotherapy. (All histological grades of NHL will be eligible for this trial.) * Measureable via CT, with at least one lesion \> or = 1.5cm in one or both dimensions. (Splenic tum...

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Frequently asked questions about radiolabeled epratuzumab

What is radiolabeled epratuzumab used for?

Radiolabeled epratuzumab is being studied for the treatment of non-Hodgkin's lymphoma, including B-cell lymphoma. It is an oncology asset developed by Gilead Sciences, Inc. The program reached Phase 1 clinical development, and the single trial testing it in this setting has been completed.

Who is developing radiolabeled epratuzumab?

Radiolabeled epratuzumab is being developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. The company sponsored the Phase 1 study of the agent in non-Hodgkin's lymphoma. It is a monoclonal antibody-based oncology program.

What phase is radiolabeled epratuzumab in?

Radiolabeled epratuzumab is in Phase 1 development. One Phase 1 trial has been conducted in non-Hodgkin's lymphoma, and that study is now completed. No later-stage trials in this program have been registered, so the asset remains an investigational agent rather than an approved therapy.

What clinical trial studied radiolabeled epratuzumab?

The Phase 1 trial of radiolabeled epratuzumab is NCT00061425, titled "Treatment of Non-Hodgkin's Lymphoma With 90Y-hLL2 IgG." It enrolled adults aged 18 years and older of any sex and evaluated the agent in non-Hodgkin's lymphoma and B-cell lymphoma. The study is completed.

How was the radiolabeled epratuzumab trial designed?

NCT00061425 was an uncontrolled, open-label Phase 1 study of radiolabeled epratuzumab in non-Hodgkin's lymphoma. It was not randomized and did not use a double-blind design. Participants were adults 18 years and older, and healthy volunteers were not eligible for enrollment.

Is radiolabeled epratuzumab FDA approved?

Radiolabeled epratuzumab is not an approved product. It is an investigational monoclonal antibody that completed a Phase 1 trial in non-Hodgkin's lymphoma, and no Phase 2 or Phase 3 studies in this program have been registered. Gilead Sciences, Inc. is the developer of the asset.