Clinical trial

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

Name

MS-553-103

Description

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

Trial arms

Trial start

2018-05-25

Estimated PCD

2024-04-15

Trial end

2024-06-15

Status

Recruiting

Phase

Early phase I

Treatment

MS-553

Oral, multiple dose levels

Arms:

Phase I Combination Dose Escalation Cohort B1, Phase I Combination Dose Escalation Cohort C1, Phase I Dose Escalation Cohort A1 (MS-553 Monotherapy)

MS-553

Oral recommended phase 2 dose of MS-553

Arms:

Experimental: Phase II Expansion Cohort C2, Phase II Expansion Cohort A2 (MS-553 Monotherapy), Phase II Expansion Cohort A3 (MS-553 Monotherapy), Phase II Expansion Cohort B2, Phase II Expansion Cohort B3

acalabrutinib

Oral

Arms:

Phase I Combination Dose Escalation Cohort B1, Phase II Expansion Cohort B2, Phase II Expansion Cohort B3

venetoclax

Oral

Arms:

Experimental: Phase II Expansion Cohort C2, Phase I Combination Dose Escalation Cohort C1

Other names:

Venclexta, Venclyxto

Rituximab

Arms:

Experimental: Phase II Expansion Cohort C2, Phase I Combination Dose Escalation Cohort C1

Other names:

Rituxan, MabThera

obinutuzumab

Arms:

Experimental: Phase II Expansion Cohort C2, Phase I Combination Dose Escalation Cohort C1

Other names:

Gazyva

Size

117

Primary endpoint

The primary objective of this study is to evaluate the safety of MS-553 in patients with CLL/SLL whose disease relapsed after or was refractory to at least one prior therapy.

Assessments for DLT and TEAE will occur during cycle 1. The primary endpoint will be the rate of DLT and TEAE requiring study drug discontinuation in the first 28 days

Eligibility criteria

Inclusion Criteria: To be eligible for inclusion in the primary escalation and expansion cohort 1 in this study, patients must meet all of the following criteria: 1. Age 18 years or older 2. Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL): 1. History of histologically documented CLL or SLL that meets IWCLL diagnostic criteria according to the 2008 guidelines, and 2. Indication for treatment as defined by the 2008 IWCLL guidelines, or the need for disease reduction prior to allogeneic transplantation Exclusion Criteria: Patients who meet any of the following criteria are not eligible for the primary escalation and expansion cohorts of this study: 1. Current or past transformation of CLL/SLL to prolymphocytic leukemia (PLL), non-Hodgkin lymphoma, or Hodgkin lymphoma aggressive lymphoma outlined in the inclusion criteria for the optional cohort. 2. Active and uncontrolled autoimmune cytopenia(s) 3. Any of the following prior therapies within 14 days prior to cycle 1, day 1: 1. Major surgery 2. Corticosteroids greater than 20 mg / day prednisone (or equivalent), unless used by inhalation or topical route, or unless necessary for premedication before iodinated contrast dye, or for autoimmune hemolytic anemia 3. Cytotoxic chemotherapy or biologic therapy, excepting BCR pathway kinase inhibitors for which no wash out is required (but must be stopped before cycle 1 day 1)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'a limited 3+3 phase 1 dose escalation study with expansion cohorts', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 117, 'type': 'ESTIMATED'}}

Updated at

2023-03-15

1 organization

5 products

3 indications

Organization

MingSight Pharmaceuticals

Product

MS-553

Indication

Chronic Lymphocytic Leukemia

Indication