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

  • Interventional
  • Recruiting
  • NCT03269136
Eligibility Details Visit Clinicaltrials.gov

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)

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.

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT03269136

IRB#IRB17-1082

Lead SponsorPfizer

Lead PhysicianAndrzej Jakubowiak

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting