Clinical Trials /

Phase 1 Study Of PF-06863135, A BCMA- CD3 Bispecific Ab, In Relapse/ Refractory Multiple Myeloma

NCT03269136

Description:

To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Phase 1 Study Of PF-06863135, A BCMA- CD3 Bispecific Ab, In Relapse/ Refractory Multiple Myeloma
  • Official Title: A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETIC, PHARMACODYNAMIC AND CLINICAL ACTIVITY OF PF-06863135, A B-CELL MATURATION ANTIGEN (BCMA)-CD3 BISPECIFIC ANTIBODY, IN PATIENTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA (MM)

Clinical Trial IDs

  • ORG STUDY ID: C1071001
  • NCT ID: NCT03269136

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
PF-06863135PF-06863135
PF-06863135PF-06863135

Purpose

To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Detailed Description

      Study C1071001 is a Phase 1, open label, multi dose, multi center, dose escalation, safety,
      pharmacokinetic (PK) and pharmacodynamic study of PF-06863135 in adult patients with advanced
      multiple myeloma who have relapsed from or are refractory to standard therapy. This two part
      study will assess the safety and tolerability of increasing dose levels of PF-06863135 in
      Part 1, and establish the recommended Phase 2 dose (RP2D) in Part 2.
    

Trial Arms

NameTypeDescriptionInterventions
PF-06863135ExperimentalBCMA-CD3 bispecific antibody
  • PF-06863135
  • PF-06863135

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with relapse/ refractory multiple myeloma

          -  Performance Status of 0- 2 (unless due to bone pain)

          -  Adequate bone marrow, kidney and liver function

        Exclusion Criteria:

          -  History of active autoimmune disorders

          -  Active and clinically significant bacterial, fungal, or viral infection

          -  Major surgery within 4 weeks of study treatment start

          -  Radiation therapy within 2 weeks of study treatment start

          -  Less than 30 days since last dose of anti CD38 therapy, elotuzumab or other anti-CD319
             therapy or less than 5 half-lives since last dose of previous systemic therapy.

          -  Stem cell transplant (autologous or allogeneic) within 100 days of study treatment
             start
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose Escalation: Number of participants with Dose-limiting toxicities (DLT)
Time Frame:21 days
Safety Issue:
Description:First cycle DLTs during dose escalation in order to determine the maximum tolerated dose (MTD).

Secondary Outcome Measures

Measure:To evaluate incidence of treatment emergent adverse events and laboratory abnormalities
Time Frame:From baseline until 1 month after end of treatment
Safety Issue:
Description:Type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities
Measure:To evaluate anti myeloma activity.
Time Frame:Baseline, 1, 3, 9 and every 6 months thereafter until disease progression, unacceptable toxicity or end of study (average of 2 years).
Safety Issue:
Description:Overall response rate
Measure:Maximum Observed Plasma Concentration (Cmax)
Time Frame:From baseline and scheduled timepoints post dose through study completion, on average 2 years
Safety Issue:
Description:Cmax will be calculated for PF-06863135.
Measure:Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast)
Time Frame:From baseline and scheduled timepoints post dose through study completion, on average 2 years
Safety Issue:
Description:Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose of PF-06863135 will be calculated.
Measure:Incidence of anti-drug antibodies
Time Frame:From baseline and scheduled timepoints post dose through study completion, on average 2 years
Safety Issue:
Description:Number of participants with the presence of anti-PF-06863135 antibodies.
Measure:Impact of PF 06863135 on systemic soluble immune factors.
Time Frame:From baseline and scheduled timepoints post dose through study completion, on average 2 years
Safety Issue:
Description:Pre and post dose quantification of soluble cytokines in serum.
Measure:To evaluate anti myeloma activity.
Time Frame:Baseline, 1, 3, 9 and every 6 months thereafter until disease progression, unacceptable toxicity or end of study (average of 2 years).
Safety Issue:
Description:Time to event endpoints including duration of response.

Details

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

Trial Keywords

  • Multiple Myeloma
  • relapse/ refractory multiple myeloma
  • bispecific antibody
  • bispecific
  • BCMA
  • BCMA- CD3 bispecific
  • Phase 1
  • PF-06863135

Last Updated