Description:
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).
Title
- Brief Title: Study to Evaluate the Safety and Tolerability of CC-92328 in Participants With Relapsed and/or Refractory Multiple Myeloma
- Official Title: A Phase 1, Multi-center, Open-label, Dose Finding Study of CC-92328 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Clinical Trial IDs
- ORG STUDY ID:
CC-92328-MM-001
- SECONDARY ID:
2020-005968-64
- NCT ID:
NCT04975399
Conditions
Interventions
Drug | Synonyms | Arms |
---|
CC-92328 | | Administration of CC-92328 |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
Administration of CC-92328 | Experimental | CC-92328 administered intravenously in 28-day cycles | |
Eligibility Criteria
Inclusion Criteria:
Participants must satisfy the following criteria to be enrolled in the study:
1. must understand and voluntarily sign an informed consent form (ICF) prior to any
study-related assessments/procedures being conducted.
2. willing and able to adhere to the study visit schedule and other protocol
requirements.
3. Participant is ≥ 18 years of age the time of signing the ICF.
4. 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.
5. Have documented disease progression on or within 12 months from the last dose of their
last myeloma therapy.
6. Participant must have measurable disease.
7. Participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of
0 or 1.
8. 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
9. Males must practice true abstinence or agree to use a condom
10. 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:
The presence of any of the following will exclude a participant from enrollment:
1. Participant has symptomatic central nervous system involvement of MM.
2. Participant had a prior autologous stem cell transplant ≤ 90 days prior to starting
CC-92328.
3. Participant had a prior allogeneic stem cell transplant with either standard or
reduced intensity conditioning ≤ 12 months prior to starting CC-92328.
4. Participant had prior systemic cancer-directed treatments or investigational
modalities ≤ 5 half-lives or 4 weeks prior to starting CC-92328, whichever is shorter.
5. Participant is a pregnant or lactating female.
6. Participant received live virus vaccines within at least 4 weeks prior to starting
study drug.
7. Participant has known active human immunodeficiency virus (HIV) infection.
8. Participant has active hepatitis B or C (HBV/HCV) infection.
9. Participant weight is ≤ 40 kg at screening.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Dose-Limiting Toxicities (DLTs) |
Time Frame: | Up to 28 days after the first dose |
Safety Issue: | |
Description: | Are defined as toxicities that meet the protocol-specified criteria occurring within the DLT assessment window (Cycle 1, Days 1 to 28) except those that are clearly and incontrovertibly due to the underlying disease or extraneous causes. |
Secondary Outcome Measures
Measure: | Preliminary Efficacy - Overall Response Rate (ORR) |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Defined as the proportion of participants who achieve a partial response (PR) or better according to IMWG response criteria. |
Measure: | Preliminary Efficacy - Time to response |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Defined as the time from the first CC-92328 dose date to the date of first documented response (PR or better). |
Measure: | Preliminary Efficacy - Duration of response |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Defined as the time from the earliest date of documented response (≥ PR) to the first documented disease progression or death, whichever occurs first. |
Measure: | Preliminary Efficacy - Progression-free Survival (PFS) |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Defined as the time from the first dose of CC-92328 to pharmacodynamics (PD) or death from any cause, whichever occurs first. |
Measure: | Preliminary Efficacy - Overall Survival (OS) |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Defined as the time from the first dose of CC-92328 to death from any cause. |
Measure: | Pharmacokinetics - Cmax |
Time Frame: | Day 1 to 9 weeks after last dose of study drug |
Safety Issue: | |
Description: | Maximum serum concentration of drug. |
Measure: | Pharmacokinetics - Cmin |
Time Frame: | Day 1 to 9 weeks after last dose of study drug |
Safety Issue: | |
Description: | Minimum serum concentration of drug. |
Measure: | Pharmacokinetics - AUC |
Time Frame: | Day 1 to 9 weeks after last dose of study drug |
Safety Issue: | |
Description: | Area under the curve. |
Measure: | Pharmacokinetics - tmax |
Time Frame: | Day 1 to 9 weeks after last dose of study drug |
Safety Issue: | |
Description: | Time to peak (maximum) serum concentration. |
Measure: | Pharmacokinetics - t1/2 |
Time Frame: | Day 1 to 9 weeks after last dose of study drug |
Safety Issue: | |
Description: | Half-life. |
Measure: | Pharmacokinetics - CL |
Time Frame: | Day 1 to 9 weeks after last dose of study drug |
Safety Issue: | |
Description: | Total body clearance of the drug from the serum. |
Measure: | Pharmacokinetics - Vd |
Time Frame: | Day 1 to 9 weeks after last dose of study drug |
Safety Issue: | |
Description: | Volume of distribution. |
Measure: | Pharmacokinetics - Accumulation index of CC-92328 |
Time Frame: | Day 1 to 9 weeks after last dose of study drug |
Safety Issue: | |
Description: | Calculated from the serum concentration-time data of CC-92328 using non-compartment methods. |
Measure: | Presence of Anti-CC92328 antibodies (ADA) |
Time Frame: | Day 1 to 9 weeks after last dose of study drug |
Safety Issue: | |
Description: | Determined using a validated bridging immunoassay with electrochemiluminescence detection. |
Measure: | Frequency of Anti-CC92328 antibodies (ADA) |
Time Frame: | Day 1 to 9 weeks after last dose of study drug |
Safety Issue: | |
Description: | Determined using a validated bridging immunoassay with electrochemiluminescence detection. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Celgene |
Trial Keywords
- Multiple Myeloma
- First-in-human
- Phase 1
- Relapsed or Refractory
- CC-92328
Last Updated
July 23, 2021