Dose Escalation/ Expansion Study of CA-4948 as Monotherapy in Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

366

Participants

Timeline

Start Date

July 6, 2020

Primary Completion Date

April 1, 2026

Study Completion Date

April 1, 2026

Conditions
Acute Myelogenous LeukemiaMyelodysplastic Syndrome
Interventions
DRUG

Emavusertib

Emavusertib is formulated as a tablet for oral administration for BID dosing in consecutive 28-day cycles. Emavusertib is a novel small molecule inhibitor of interleukin-1 receptor-associated kinase 4 (IRAK4). IRAK4 kinase plays an essential role in toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways and these pathways are frequently dysregulated in non-Hodgkin's lymphoma and AML/MDS malignancies.

DRUG

Venetoclax

"Ventoclax is B-cell lymphoma-2 (BCL-2) inhibitor. Venetoclax will be administered at 100 mg orally (Day 1) per the product label at the same time each day with a ramp up over 3 days to 400 mg for 21days of a 28-day Cycle. Second and subsequent cycles start with target dose level.~This arm of the study has been closed to enrollment."

DRUG

Emavusertib

Emavusertib is formulated as a tablet for oral administration for BID dosing for 21 days (Days 1-21) of a 28-day Cycle.

Trial Locations (32)

6200

COMPLETED

Service d'hématologie clinique CHU de Nice, Nice

10461

ACTIVE_NOT_RECRUITING

Albert Einstein Medical College, The Bronx

14642

COMPLETED

University of Rochester Medical Center, Rochester

20246

COMPLETED

Universitätsklinikum Hamburg-Eppendorf (UKE), Hamburg

27103

COMPLETED

Novant Health Hematology - Forsyth, Winston-Salem

28006

COMPLETED

Hospital Universitaro del a Princesa, Madrid

30322

COMPLETED

Winship Cancer Institute, Atlanta

33612

ACTIVE_NOT_RECRUITING

Moffitt Cancer Center, Tampa

40479

COMPLETED

Marien Hospital Dusseldorf; Klinik fur Onkologie und Hamatologie, Palliativmedizin, Düsseldorf

43210

COMPLETED

The Ohio State University Wexner Medical Center - James Cancer Hospital, Columbus

48149

COMPLETED

Universitatsklinikum Munster, Münster

48201

COMPLETED

Karmanos Cancer Institute, Detroit

60611

ACTIVE_NOT_RECRUITING

Northwestern Memorial Hospital, Chicago

60637

COMPLETED

University of Chicago Medical Center, Chicago

68130

COMPLETED

Oncology Hematology West, PC dba Nebraska Cancer Specialists, Omaha

75012

COMPLETED

APHP - Sorbonne Universite, Paris

75475

COMPLETED

APHP - Hopital Saint Louis, Paris

77030

ACTIVE_NOT_RECRUITING

The University of Texas MD Anderson Cancer Center, Houston

81675

COMPLETED

Klinikum rechts der Isar der Technischen Universitat Munchen, München

84100

COMPLETED

Soroka University MC, Beersheba

5822012

COMPLETED

Edith Wolfson Medical Center, Holon

9112001

COMPLETED

Hadassah University MC, Jerusalem

02215

RECRUITING

Dana Farber Cancer Institute, Boston

12 808

COMPLETED

Vseobecna Fakultni nemocnice v Praze, Prague

04103

COMPLETED

Universitatsklinikum Leipzig; Medizinische Klinik und Poliklinik I, Leipzig

Unknown

COMPLETED

Azienda Ospedaliera Santa Croce e Carle, Cuneo

COMPLETED

"Instituto Romagnolo per lo Studio dei Tumori Dino Amadori", Meldola

COMPLETED

Hospital de la Santa Creu I Sant Pau (Neuvo Hospital), Barcelona

COMPLETED

MD Anderson Cancer Center Madrid, Madrid

COMPLETED

Hospital Universitario Virgen del Rocio, Seville

80-214

COMPLETED

Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz, Gdansk

31 501

COMPLETED

University Hospital in Krakow, Krakow

All Listed Sponsors
lead

Curis, Inc.

INDUSTRY