Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS

Part of paid clinical trials in Duarte, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04810611
Phase
PHASE1
Status
Terminated

Conditions

  • Myelodysplastic Syndromes

Eligibility Criteria

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

Interventions

  • MBG453 — DRUG
    Anti-TIM3 monoclonal antibody
  • NIS793 — DRUG
    Anti-TGF-β monoclonal antibody
  • canakinumab — DRUG
    Anti-IL-1β monoclonal antibody

Study Details

The purpose of this study was to characterize the safety, tolerability and confirm the dose for select single agents and combinations in patients with lower risk (very low, low, and intermediate risk) MDS.

Key Dates

Start date
Jun 18, 2021
Status verified
Oct 2025
Primary completion
Apr 19, 2024
Completion
Apr 19, 2024

Study Design

Enrollment
33 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: MBG453 single agent
    Treatment with MBG453 single agent Q4W to confirm safety and tolerability of RD.
  • Experimental: Arm 2: NIS793 single agent
    Treatment with NIS793 single agent Q3W to establish RD in this indication and confirm safety and tolerability.
  • Experimental: Arm 3: canakinumab single agent
    Treatment with single agent canakinumab Q4W to confirm safety and tolerability of RD.
  • Experimental: Arm 4: MBG453 + NIS793 combination
    Treatment with combination of MBG453 and NIS793 Q3W to confirm safety and tolerability of combination RD.
  • Experimental: Arm 5: MBG453 + canakinumab combination
    Treatment with MBG453 + canakinumab combination Q4W to confirm safety and tolerability of combination RD.

Primary Outcome Measure

Dose interruption reduction [ Time Frame: 30 Months ]

Locations (5)

FacilityCityStateZIPSite coordinators
City Of Hope National Med Center OncologyDuarteCalifornia91010-
H Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Massachusetts General Hospital .BostonMassachusetts02114-
The Ohio State University Wexner Medical Center .ColumbusOhio43210-
MD Anderson Cancer Center/University of Texas MD AndersonHoustonTexas77030-

Find similar trials in Duarte, CA

By research site
City Of Hope National Med Center Oncology· Duarte, CAH Lee Moffitt Cancer Center and Research Institute· Tampa, FLMassachusetts General Hospital .· Boston, MAThe Ohio State University Wexner Medical Center .· Columbus, OHMD Anderson Cancer Center/University of Texas MD Anderson· Houston, TX

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