A Study Of The Selective PKC-β Inhibitor MS- 553

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
MingSight Pharmaceuticals, Inc
Study ID
NCT03492125
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • MS-553 — DRUG
    Oral, multiple dose levels
  • MS-553 — DRUG
    Oral recommended phase 2 dose of MS-553
  • acalabrutinib — DRUG
    Oral
  • venetoclax — DRUG
    Oral
  • Rituximab — DRUG
    IV
  • obinutuzumab — DRUG
    IV

Study Details

A Phase I/II Dose-Escalation and Expansion Study Of The Selective PKC-Β Inhibitor MS-553 In Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Key Dates

Start date
May 25, 2018
Status verified
Apr 2025
Primary completion
Nov 28, 2023
Completion
Nov 28, 2023

Study Design

Enrollment
60 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I Dose Escalation Cohort A1 (MS-553 Monotherapy)
    R/R CLL/SLL patients
  • Experimental: Phase II Expansion Cohort A2 (MS-553 Monotherapy)
    R/R CLL/SLL patients
  • Experimental: Phase II Expansion Cohort A3 (MS-553 Monotherapy)
    patients with aggressive lymphoma
  • Experimental: Phase I Combination Dose Escalation Cohort B1
    BTK inhibitor naïve CLL/SLL patients
  • Experimental: Phase II Expansion Cohort B2
    BTK inhibitor naïve CLL/SLL patients
  • Experimental: Phase II Expansion Cohort B3
    BTK inhibitor naïve CLL/SLL patients with certain gene mutations
  • Experimental: Phase I Combination Dose Escalation Cohort C1
    Bcl-2 inhibitor naïve CLL/SLL patients
  • Experimental: Experimental: Phase II Expansion Cohort C2
    Bcl-2 inhibitor naïve CLL/SLL patients

Primary Outcome Measure

The Incidence Rate of DLT and TEAE Requiring Study Drug Discontinuation [ Time Frame: Assessments for DLT and TEAE will occur during Cycle 1 (28 days) for A1 Cohort and B1 Cohort and Cycles 1-4 (up to 112 days) for C1 Cohort. ]

Locations (5)

FacilityCityStateZIPSite coordinators
University Of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Columbia University, Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
The Ohio State University, James Comprehensive Cancer CenterColumbusOhio43210-
MD Anderson Cancer Center, Department of LeukemiaHoustonTexas77030-
Huntsman Cancer InstituteSalt Lake CityUtah84112-

Find similar trials in Ann Arbor, MI

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University Of Michigan Comprehensive Cancer Center· Ann Arbor, MIColumbia University, Herbert Irving Comprehensive Cancer Center· New York, NYThe Ohio State University, James Comprehensive Cancer Center· Columbus, OHMD Anderson Cancer Center, Department of Leukemia· Houston, TXHuntsman Cancer Institute· Salt Lake City, UT

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