A Phase 1, Multi-center, Open-label, Dose Finding Study of CC-92328 in Subjects with Relapsed and/or Refractory Multiple Myeloma
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).
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
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.
Please call 1-888-663-3488 for support from a Moffitt representative. New Patients and Healthcare Professionals can submit an online form by selecting the appropriate button below. Existing patients can call 1-888-663-3488. Click here for a current list of insurances accepted at Moffitt.
NEW PATIENTS To request a new patient appointment, please fill out the online form or call 1-888-663-3488.
REFERRING PHYSICIANS Providers and medical staff can refer patients by submitting our online referral form.
Moffit now offers Virtual Visits for patients. If you are eligible for a virtual appointment, our scheduling team will discuss this option further with you.
Moffitt Cancer Center is committed to the health and safety of our patients and their families. For more information on how we’re protecting our new and existing patients, visit our COVID-19 Info Hub