Clinical trial NCT04975399: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
First-in-human
Phase 1
Relapsed or Refractory
CC-92328
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2021-07-23
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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 12 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 12 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.

Primary outcomes:
measure: Dose-Limiting Toxicities (DLTs)
timeFrame: Up to 28 days after the first dose
measure: Maximum Tolerated Dose (MTD)
timeFrame: Up to 12 weeks after the last dose
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 12 weeks after the last dose
Secondary outcomes:
measure: Preliminary Efficacy - Overall Response Rate (ORR)
timeFrame: Up to approximately 2 years
measure: Preliminary Efficacy - Time to response
timeFrame: Up to approximately 2 years
measure: Preliminary Efficacy - Duration of response
timeFrame: Up to approximately 2 years
measure: Preliminary Efficacy - Progression-free Survival (PFS)
timeFrame: Up to approximately 2 years
measure: Preliminary Efficacy - Overall Survival (OS)
timeFrame: Up to approximately 2 years
measure: Pharmacokinetics - Cmax
timeFrame: Day 1 to 9 weeks after last dose of study drug
measure: Pharmacokinetics - Cmin
timeFrame: Day 1 to 9 weeks after last dose of study drug
measure: Pharmacokinetics - AUC
timeFrame: Day 1 to 9 weeks after last dose of study drug
measure: Pharmacokinetics - tmax
timeFrame: Day 1 to 9 weeks after last dose of study drug
measure: Pharmacokinetics - t1/2
timeFrame: Day 1 to 9 weeks after last dose of study drug
measure: Pharmacokinetics - CL
timeFrame: Day 1 to 9 weeks after last dose of study drug
measure: Pharmacokinetics - Vd
timeFrame: Day 1 to 9 weeks after last dose of study drug
measure: Pharmacokinetics - Accumulation index of CC-92328
timeFrame: Day 1 to 9 weeks after last dose of study drug
measure: Presence of Anti-CC92328 antibodies (ADA)
timeFrame: Day 1 to 9 weeks after last dose of study drug
measure: Frequency of Anti-CC92328 antibodies (ADA)
timeFrame: Day 1 to 9 weeks after last dose of study drug
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 104
state: Alabama
city: Scottsdale
country: United States
facility: Local Institution - 105
state: Arizona
city: Tampa
country: United States
facility: Local Institution - 106
state: Florida
city: New York
country: United States
facility: Local Institution - 108
state: New York
city: New York
country: United States
facility: Local Institution - 107
state: New York
city: Milwaukee
country: United States
facility: Local Institution - 101
state: Wisconsin
city: Calgary
country: Canada
facility: Local Institution - 201
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution - 204
state: Alberta
city: Halifax
country: Canada
facility: Local Institution - 203
state: Nova Scotia
city: Toronto
country: Canada
facility: Local Institution - 202
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 205
state: Quebec
city: Pamplona
country: Spain
facility: Local Institution - 302
state: Navarra
city: Badalona
country: Spain
facility: Local Institution - 301
city: Salamanca
country: Spain
facility: Local Institution - 303
city: Santander
country: Spain
facility: Local Institution - 304
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: