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Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies

NCT02290951 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-10-10

No results posted yet for this study

Summary

This study has two parts with distinct study objectives and study design. In part A, odronextamab is studied as an intravenous (IV) administration with a dose escalation and a dose expansion phase for B-NHL and CLL. The dose escalation phase for B-NHL and the CLL study are closed at the time of protocol amendment 17. In part B, odronextamab is studied as a subcutaneous (SC) administration with a dose finding and a dose expansion phase for B-NHL.

Conditions

Interventions

DRUG

Odronextamab multiple dose levels

Administered by intravenous (IV) infusion

DRUG

Odronextamab multiple dose levels

Administered by subcutaneous (SC) injection

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-09
Primary Completion
2025-08-21
Completion
2025-08-21
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Israel
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02290951 on ClinicalTrials.gov