Last updated on September 2018

Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies


Brief description of study

Primary Objective:

Phase 1:

To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984 (Isatuximab).

Phase 2 (stage 1):

To evaluate the activity of single-agent Isatuximab at different doses/schedules and to select dose and regimen to further evaluate the overall response rate (ORR) of Isatuximab as single agent or in combination with dexamethasone.

Phase 2 (stage 2):

To evaluate the activity in terms of overall response rate (ORR) of Isatuximab at the selected dose/schedule from stage1, as single agent (ISA arm) and in combination with dexamethasone (ISAdex arm).

Secondary Objectives:

Phase 1:

  • To characterize the global safety profile including cumulative toxicities.
  • To evaluate the pharmacokinetic (PK) profile of Isatuximab in the proposed dosing schedule(s).
  • To assess the pharmacodynamics (PD), immune response, and preliminary disease response.

Phase 2 (stage 1): to evaluate the following objectives for Isatuximab as single agent:

  • Safety
  • Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival.

Phase 2 (stage 2): to evaluate the following objectives in each arm (ISA and ISAdex):

  • Safety
  • Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival.

Detailed Study Description

The Phase 1 study duration for an individual patient will include a screening period for inclusion of up to 2 weeks, treatment with Isatuximab QW (every week) or Q2W (every 2 weeks) unless discontinued earlier due to safety or disease progression. Patients will be followed for a minimum of 30 days following the last use of study drug or more than 30 days in case of unresolved toxicity, or up to initiation of another anticancer treatment.

The Phase 2 study duration for an individual patient will include a screening period for inclusion of up to 3 weeks, then a treatment period and a follow up period. Treatment will continue until disease progression, unacceptable adverse reactions or other reasons for discontinuation. Patients will be followed every 3 months following the last use of study drug until death or study cutoff whichever comes first.

Clinical Study Identifier: NCT01084252

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Investigational Site Number 604001
Arequipa, Peru