A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Teva Branded Pharmaceutical Products R&D LLC
Study ID
NCT05590377
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Modakafusp Alfa — DRUG
    Modakafusp alfa intravenous infusion
  • Daratumumab — DRUG
    Daratumumab SC injection

Study Details

The main aim of this study is to determine safety and tolerability of modakafusp alfa given together with daratumumab to find out the best treatment dose. Another aim of this study is to learn more about the characteristics of modakafusp alfa.

Key Dates

Start date
Jan 23, 2023
Status verified
Jan 2026
Primary completion
May 22, 2024
Completion
May 22, 2024

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab
    Modakafusp alfa 80 mg, infusion, intravenously (IV), once every 4 weeks (Q4W) with daratumumab 1800 mg, subcutaneously (SC), once weekly (QW) in Cycles 1 and 2, twice weekly (Q2W) in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.
  • Experimental: Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab
    Modakafusp alfa 120 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.
  • Experimental: Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Modakafusp alfa 240 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.
  • Experimental: Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab
    Modakafusp alfa at dose level 1 (DL1) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.
  • Experimental: Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
    Modakafusp alfa at dose level 2 (DL2) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.

Primary Outcome Measure

Phase 1: Number of Participants With Dose Limiting Toxicities (DLT) [ Time Frame: Phase 1: Cycle 1 (cycle length=28 days) ]

Locations (13)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
Cedars-Sinai Medical CenterLos AngelesCalifornia77598-
Fort Wayne Medical Oncology and Hematology, IncFort WayneIndiana46060-
HCA Midwest Health (Midwest Ventures Group HCA MidAmerica Division)Overland ParkKansas66211-
Tulane University Health Sciences CenterNew OrleansLouisiana70112-
Floating Hospital for Children at Tufts Medical CenterBostonMassachusetts02111-
Washington University School of MedicineSt LouisMissouri63130-
University of Nebraska Medical CenterOmahaNebraska68198-
Summit Medical Group PAFlorham ParkNew Jersey07932-
New York Cancer and Blood SpecialistsBay ShoreNew York11706-
Stony Brook University HospitalStony BrookNew York11794-
University of Cincinnati - Vontz Center for Molecular StudiesCincinnatiOhio45267-
Tranquil Clinical ResearchWebsterTexas78041-

Find similar trials in Gilbert, AZ

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Banner MD Anderson Cancer Center· Gilbert, AZCedars-Sinai Medical Center· Los Angeles, CAFort Wayne Medical Oncology and Hematology, Inc· Fort Wayne, INHCA Midwest Health (Midwest Ventures Group HCA MidAmerica Division)· Overland Park, KSTulane University Health Sciences Center· New Orleans, LAFloating Hospital for Children at Tufts Medical Center· Boston, MA

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