Clinical Trials /

A Phase 1/2 Study of AMG 701 in Subjects With Multiple Myeloma

NCT03287908

Description:

The primary purpose of the phase 1 part of the study is to estimate the maximum tolerated dose (MTD) and/or a biologically active dose (eg, RP2D) and to confirm the safety and tolerability of the RP2D. The dose escalation part of the study will be conducted at multiple sites and test increasing doses and dosing schedules of AMG 701. This will be followed by Phase 1b dose confirmation and Phase 2 dose expansion parts to gain further efficacy and safety experience with AMG 701. The safety of subjects will be monitored by intensive assessments of vital signs, electrocardiograms, physical examinations, and laboratory tests.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Phase 1 Study of AMG 701 in Subjects With Multiple Myeloma
  • Official Title: A Phase 1 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 701 in Subjects With Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: 20170122
  • SECONDARY ID: 2017-001997-41
  • NCT ID: NCT03287908

Conditions

  • Relapsed/Refractory Multiple Myeloma

Interventions

DrugSynonymsArms
AMG 701AMG 701

Purpose

The purpose of this First-in-Human Phase 1 study is to determine during the escalation part if AMG 701 given as weekly short term IV infusions is safe and tolerable followed by a dose expansion part to gain further efficacy and safety experience with AMG 701 in adult subjects with relapsed / refractory multiple myeloma. The study will be conducted in multiple sites and test increasing doses of AMG 701. The safety of subjects will be monitored by intensive assessments of vital signs, electrocardiograms, physical examinations, and laboratory tests.

Trial Arms

NameTypeDescriptionInterventions
AMG 701ExperimentalComparison of different dosages of drug
  • AMG 701

Eligibility Criteria

        Inclusion Criteria:

          -  Multiple myeloma meeting the following criteria:

               -  Pathologically-documented diagnosis of multiple myeloma that is relapsed or is
                  refractory as defined by the following:

                    -  Relapsed after > or = 2 lines of prior therapy that must include a
                       proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and, where
                       approved and available, a CD38-directed cytolytic antibody in any order
                       during the course of treatment OR refractory to PI, IMiD, and CD38- directed
                       cytolytic antibody,

                    -  Subjects who could not tolerate a PI, IMiDs, or a CD38-directed cytolytic
                       antibody are eligible to enroll in the study.

               -  Measurable disease as per IMWG response criteria

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2

        Exclusion Criteria:

          -  Extramedullary disease in the absence of any measurable medullary involvement

          -  Known central nervous system involvement by multiple myeloma

          -  Autologous stem cell transplantation less than 90 days prior to study day 1

          -  Multiple myeloma with IgM subtype

          -  POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and
             skin changes)

          -  Known history of primary plasma cell leukemia or evidence of primary or secondary
             plasma cell leukemia at the time of screening

          -  Waldenstrom's macroglobulinemia

          -  Amyloidosis

          -  Treatment with systemic immune modulators including, but not limited to, nontopical
             systemic corticosteroids (unless the dose is ≤ 10 mg/day prednisone or equivalent),
             cyclosporine, and tacrolimus within 2 weeks before study day 1

          -  Last anticancer treatment (chemotherapy, IMiD, PI, molecular targeted therapy) < 2
             weeks prior to study day 1 or treatment with a therapeutic antibody less than 4 weeks
             prior to study day 1 as well as systemic radiation therapy within 28 days prior to
             study day 1 or focal radiotherapy within 14 days prior to study day 1.

          -  Prior treatment with a drug that targets BCMA on tumor cells or any other bi specific
             antibody construct or chimeric antigen receptor T cell (CAR-T) infusion for the
             treatment of multiple myeloma
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Subject incidence of adverse events as a Measure of Safety
Time Frame:48 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Anti-tumor activity
Time Frame:48 months
Safety Issue:
Description:Efficacy parameter measured by IMWG response criteria: stringent Complete Response (CR)
Measure:Anti-tumor activity
Time Frame:48 months
Safety Issue:
Description:Progression-free survival
Measure:Pharmacokinetic parameter of AMG 701
Time Frame:12 weeks
Safety Issue:
Description:Maximum concentration (Cmax)
Measure:Pharmacokinetic parameter of AMG 701
Time Frame:12 weeks
Safety Issue:
Description:Time of maximum concentration (Tmax)
Measure:Pharmacokinetic parameter of AMG 701
Time Frame:12 weeks
Safety Issue:
Description:Area under the concentration-time curve (AUC)
Measure:Anti-tumor activity
Time Frame:48 months
Safety Issue:
Description:Efficacy parameter measured by IMWG response criteria: CR
Measure:Anti-tumor activity
Time Frame:48 months
Safety Issue:
Description:Efficacy parameter measured by IMWG response criteria: very good Partial Response (PR)
Measure:Anti-tumor activity
Time Frame:48 months
Safety Issue:
Description:Efficacy parameter measured by IMWG response criteria: PR
Measure:Anti-tumor activity
Time Frame:48 months
Safety Issue:
Description:Overall survival

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Amgen

Trial Keywords

  • Amgen
  • Phase 1
  • Clinical Trial
  • Oncology/Hematology
  • Relapsed/Refractory Multiple Myeloma
  • Immunotherapy

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