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Clinical Trial 21550

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT04975399

Phase: Phase I
Principal Investigator: Baz, Rachid

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or 1-800-679-0775 Learn More
Overview

Study Title

A Phase 1, Multi-center, Open-label, Dose Finding Study of CC-92328 in Subjects with Relapsed and/or Refractory Multiple Myeloma

Summary

This Phase 1, first-in-human (FIH), clinical study of CC-92328 will explore the safety, tolerability and preliminary biological and clinical activity of CC-92328 as a single-agent in the setting of relapsed and/or refractory multiple myeloma (R/R MM). The study will be conducted in two parts: monotherapy dose escalation (Part A) and monotherapy dose expansion (Part B).

Objective

1. To determine the safety and tolerability of CC-92328 in subjects with R/R MM; 2. To define the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of CC-92328 in subjects with R/R MM; 3. To evaluate the preliminary efficacy of CC-92328 in R/R MM; 4. To characterize the pharmacokinetics (PK) of CC-92328; 5. To determine the presence, frequency, and functional impact of anti-CC-92328 antibodies (ADA).

Treatments

Therapies

Therapy (NOS)

Medications

CC-92328 ()

Inclusion Criteria

  • Must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
  • Willing and able to adhere to the study visit schedule and other protocol requirements.
  • Participant is > 18 years of age the time of signing the ICF.
  • Participant has a history of multiple myeloma (MM) with relapsed and/or refractory disease who have failed or who are ineligible or intolerant to available therapies that may provide clinical benefit.
  • Have documented disease progression on or within 12 months from the last dose of their last myeloma therapy.
  • Participant must have measurable disease.
  • Participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
  • Females of childbearing potential (FCBP) must commit to true abstinence from heterosexual contact or agree to use at least one method of highly effective contraception without interruption from screening to at least 9 weeks after the last dose of CC-92328
  • Males must practice true abstinence or agree to use a condom
  • FCBP and males must avoid conceiving from signing the ICF, while participating in the study, during dose interruptions, and for at least 9 weeks after the last dose of CC-92328.

  • Exclusion Criteria

  • Participant has symptomatic central nervous system involvement of MM.
  • Participant had a prior autologous stem cell transplant ≤ 90 days prior to starting CC-92328.
  • Participant had a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 12 months prior to starting CC-92328.
  • Participant had prior systemic cancer-directed treatments or investigational modalities ≤ 5 half-lives or 4 weeks prior to starting CC-92328, whichever is shorter.
  • Participant is a pregnant or lactating female.
  • Participant received live virus vaccines within at least 4 weeks prior to starting study drug.
  • Participant has known active human immunodeficiency virus (HIV) infection.
  • Participant has active hepatitis B or C (HBV/HCV) infection.
  • Participant weight is < 40 kg at screening.

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.