Study to Evaluate the Safety and Tolerability of CC-92328 in Participants With Relapsed and/or Refractory Multiple Myeloma

Sponsor

Celgene (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04975399

Collaborator

(none)

Enrollment

Locations

Arm

52.2

Anticipated Duration (Months)

4.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: CC-92328	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 5, 2021

Anticipated Primary Completion Date :

Feb 10, 2026

Anticipated Study Completion Date :

Feb 10, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Administration of CC-92328 CC-92328 administered intravenously in 28-day cycles	Drug: CC-92328 CC-92328

Arm

Intervention/Treatment

Experimental: Administration of CC-92328

CC-92328 administered intravenously in 28-day cycles

Drug: CC-92328

CC-92328

Outcome Measures

Primary Outcome Measures

Dose-Limiting Toxicities (DLTs) [Up to 28 days after the first dose]
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.
Maximum Tolerated Dose (MTD) [Up to 9 weeks after the last dose]
Defined as the highest dose at which less than 33% of the population treated with CC-92328 experience a dose-limiting toxicity (DLT) in the first cycle and at least 6 evaluable participants have been treated at this dose level.
Incidence of Adverse Events (AEs) [Up to 9 weeks after the last dose]
Type, frequency, seriousness, severity and relationship of AEs to CC-92328.

Secondary Outcome Measures

Preliminary Efficacy - Overall Response Rate (ORR) [Up to approximately 2 years]
Defined as the proportion of participants who achieve a partial response (PR) or better according to IMWG response criteria.
Preliminary Efficacy - Time to response [Up to approximately 2 years]
Defined as the time from the first CC-92328 dose date to the date of first documented response (PR or better).
Preliminary Efficacy - Duration of response [Up to approximately 2 years]
Defined as the time from the earliest date of documented response (≥ PR) to the first documented disease progression or death, whichever occurs first.
Preliminary Efficacy - Progression-free Survival (PFS) [Up to approximately 2 years]
Defined as the time from the first dose of CC-92328 to pharmacodynamics (PD) or death from any cause, whichever occurs first.
Preliminary Efficacy - Overall Survival (OS) [Up to approximately 2 years]
Defined as the time from the first dose of CC-92328 to death from any cause.
Pharmacokinetics - Cmax [Day 1 to 9 weeks after last dose of study drug]
Maximum serum concentration of drug.
Pharmacokinetics - Cmin [Day 1 to 9 weeks after last dose of study drug]
Minimum serum concentration of drug.
Pharmacokinetics - AUC [Day 1 to 9 weeks after last dose of study drug]
Area under the curve.
Pharmacokinetics - tmax [Day 1 to 9 weeks after last dose of study drug]
Time to peak (maximum) serum concentration.
Pharmacokinetics - t1/2 [Day 1 to 9 weeks after last dose of study drug]
Half-life.
Pharmacokinetics - CL [Day 1 to 9 weeks after last dose of study drug]
Total body clearance of the drug from the serum.
Pharmacokinetics - Vd [Day 1 to 9 weeks after last dose of study drug]
Volume of distribution.
Pharmacokinetics - Accumulation index of CC-92328 [Day 1 to 9 weeks after last dose of study drug]
Calculated from the serum concentration-time data of CC-92328 using non-compartment methods.
Presence of Anti-CC92328 antibodies (ADA) [Day 1 to 9 weeks after last dose of study drug]
Determined using a validated bridging immunoassay with electrochemiluminescence detection.
Frequency of Anti-CC92328 antibodies (ADA) [Day 1 to 9 weeks after last dose of study drug]
Determined using a validated bridging immunoassay with electrochemiluminescence detection.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants must satisfy the following criteria to be enrolled in the study:

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:

The presence of any of the following will exclude a participant from enrollment:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Hospital	Birmingham	Alabama	United States	35233
2	HonorHealth Research Institute	Scottsdale	Arizona	United States	85258
3	University of South Florida (USF)	Tampa	Florida	United States	33612
4	Johns Hopkins Oncology Center	Baltimore	Maryland	United States	21231
5	Memorial Sloan-Kettering Cancer Center - David H. Koch Center for Cancer Care	New York	New York	United States	10021
6	Mt. Sinai Medical Center Division of Hematology/Oncology	New York	New York	United States	10029
7	Froedtert Hospital BMT Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226-3522
8	Tom Baker Cancer Center	Calgary	Alberta	Canada	T2N 4N2
9	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
10	Dalhousie University	Halifax	Nova Scotia	Canada	B3H 2Y9
11	Princess Margaret Hospital University Health Network	Toronto	Ontario	Canada	M5G 2M9
12	McGill University Health Center (MUHC)	Montreal	Quebec	Canada	H4A 3J1
13	Hospital Germans Trias I Pujol	Badalona		Spain	8916
14	Clinica Universidad de Navarra	Pamplona		Spain	31008
15	Hospital Universitario de Salamanca	Salamanca		Spain	37007
16	Hospital Universtario Marques de Valdecilla	Santander		Spain	39008
17	Sahlgrenska Universitetssjukhus	Göteborg		Sweden	SE-41685