Safety, Efficacy, Dose-finding Study of a Monoclonal Antibody in Patients With Multiple Myeloma

A Phase I, Dose-finding Trial of HCD122, an Anti-CD40 Monoclonal Antibody, in Patients With Multiple Myeloma That is Relapsed or Has Not Responded to Prior Therapy (CHIR1212-C12101)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00231166

Enrollment

Registered

2005-10-04

Start date

2005-09-30

Completion date

2009-05-31

Last updated

2018-10-11

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

Conditions

Multiple Myeloma

Keywords

dose-finding, monoclonal antibody, Multiple Myeloma

Brief summary

The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with Multiple Myeloma who are relapsed after receiving prior treatment.

Interventions

DRUGHCD122

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* Clinical Diagnosis of MM requiring treatment * Refractory or Relapsed Disease * At least one prior treatment regimen * Male or Female * \>18 years of age

Exclusion criteria

* Prior Allogeneic bone marrow transplant (prior autologous transplant allowed) * Intracranial disease or epidural disease * Clinically significant cardiac dysfunction or other significant organ dysfunction

Design outcomes

Primary

Measure	Time frame
Safety, pharmacokinetics and pharmacodynamics at multiple doses	At the completion of each dose escalation cohort

Secondary

Measure	Time frame
Clinical response after various doses	Once a month

Countries

Australia, United States

Outcome results

None listed

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