Study of TRM-1 (TRAIL-R1 Monoclonal Antibody) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)

A Multi-Center, Open-Label, Dose-Escalation Study to Evaluate the Safety, Efficacy, and Exposure to TRM-1 (Fully Human Monoclonal Antibody to the TRAIL-R1) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00094848

Enrollment

Unknown

Registered

2004-10-27

Start date

2004-06-30

Completion date

2007-05-31

Last updated

2013-08-02

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

Conditions

Lymphoma, Non-Hodgkin

Brief summary

The purpose of this study is to evaluate the safety, efficacy and exposure to TRM-1 in subjects with relapsed or refractory Non-Hodgkin's Lymphoma (NHL).

Interventions

DRUGTRAIL-R1 mAb (TRM-1; HGS-ETR1)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Primary Inclusion Criteria: * Relapsed or refractory histologically confirmed Non-Hodgkin's Lymphoma * Previously treated with at least 1 therapeutic regimen and relapsed or progressed or failed to achieve a response after the last regimen * 18 years of age or older Primary

Exclusion criteria

* Received a non-FDA approved investigational agent within the last 4 weeks * Received cancer therapies (chemotherapy, biological therapy \[including hormonotherapy\], radiation therapy or immunosuppressants within the last 3 weeks, 8 weeks for monoclonal antibodies, radioimmunotherapy or nitrosourea * Eligible for a hematopoietic stem cell transplant (HSCT) or have had an autologous HSCT within the last 16 weeks * Prior history of an allogeneic HSCT * HIV, AIDS-related lymphoma, central nervous system (CNS) lymphoma, Hepatitis-B or Hepatitis-C * Infection requiring antibiotics within the last 4 weeks * Major surgery within the last 4 weeks * Pregnant or breast-feeding women * History of other cancers within the past 5 years

Countries

United States

Outcome results

None listed

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