Phase 1 Study Of PF-06863135, A BCMA- CD3 Bispecific Ab, As A Single Agent And In Combination With Either PF-06801591 Or Lenalidomide In Relapse/ Refractory Multiple Myeloma

Titre officiel

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, AS A SINGLE AGENT AND IN COMBINATION WITH EITHER PF-06801591 OR LENALIDOMIDE IN PATIENTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA (MM)

Sommaire:

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.

Description de l'essai

Primary Outcome:

  • Dose Escalation: Number of participants with Dose-limiting toxicities (DLT)
  • To evaluate anti-myeloma activity by objective response rate (ORR) in dose expansion
  • To evaluate anti-myeloma activity by duration of response (DOR) in dose expansion
Secondary Outcome:
  • To evaluate incidence of treatment emergent adverse events and laboratory abnormalities
  • To evaluate anti-myeloma activity by objective response rate (ORR) in dose escalation
  • To evaluate anti-myeloma activity by time to event endpoints
  • To evaluate anti-myeloma activity by duration of event endpoints
  • Impact of treatment on systemic soluble immune factors
  • Maximum plasma concentration (Cmax) of PF-06863135
  • Trough serum concentrations of PF-06863135 and PF-06801591
  • Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-06863135
  • Incidence and titers of anti-drug antibodies and neutralizing antibodies against PF-06863135 and PF-06801591 when combined with PF-06863135
Study C1071001 is a Phase 1, open label, multi dose, multi centre, 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.

Voir cet essai sur ClinicalTrials.gov

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