A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Official Title

A Phase 1b Dose Escalation Study of the Combination of the Bispecific T Cell Redirection Antibodies Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Summary:

The purpose of this study is to identify the recommended Phase 2 regimen(s) (RP2R[s]) and schedule for the study treatment (Part 1) and to characterize the safety of the RP2R(s) for the study treatment (Part 2). The RP2R will describe the combination doses and schedules of talquetamab and teclistamab to be pursued in Phase 2.

Trial Description

Primary Outcome:

  • Part 1: Number of Participants with Dose Limiting Toxicity (DLT)
  • Part 1: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
  • Part 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
  • Part 2: Number of Participants with Adverse Events and SAEs by Severity
Secondary Outcome:
  • Part 1 and Part 2: Serum Concentration of Talquetamab
  • Part 1 and Part 2: Serum Concentration of Teclistamab
  • Part 1 and Part 2: Number of Participants with Anti-Drug Antibodies to Talquetamab
  • Part 1 and Part 2: Number of Participants with Anti-Drug Antibodies to Teclistamab
  • Part 1 and Part 2: Overall Response Rate (ORR)
  • Part 1 and Part 2: Very Good Partial Response (VGPR) or Better Response Rate
  • Part 1 and Part 2: Complete Response (CR) or Better Response Rate
  • Part 1 and Part 2: Stringent Complete Response (sCR) Rate
  • Part 1 and Part 2: Duration of Response (DOR)
  • Part 1 and Part 2: Time to Response
Multiple myeloma is a malignant plasma cell disorder characterized by production of monoclonal proteins (M proteins), which are comprised of pathologic immunoglobulins (Ig) or fragments of such, which have subsequently lost their normal function. Talquetamab is a humanized IgG4PAA bispecific antibody designed to target G protein-coupled receptor family C group 5-member D (GPRC5D) and the CD3 molecule found on T lymphocytes (T cell). Teclistamab is a humanized IgG4PAA bispecific antibody designed to target B cell maturation antigen (BCMA) and the CD3 molecule found on T cells. Rationale for combining talquetamab and teclistamab is that, these agents promote the activation of T cells and induce myeloma cell lysis mediated by secreted perforin and various granzymes stored in the secretory vesicles of cytotoxic T cells. This study consists 3 periods: screening phase (up to 28 days), treatment phase (start of study drug administration and continues until the completion of the end of treatment [EOT] visit); and a post-treatment follow-up phase (after end of treatment and up to 16 weeks after last dose of study drug(s) for each participant). End of study is defined as last study assessment for last participant in study. Total duration of study is up to 1 years. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points during this study. Participants safety and study conduct will be monitored throughout the study.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society