Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers

PHASE1CompletedINTERVENTIONAL
Enrollment

279

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

October 31, 2024

Study Completion Date

October 31, 2024

Conditions
HER2-expressing Cancers
Interventions
DRUG

ZW25 (Zanidatamab)

ZW25 administered IV once weekly, once every 2 weeks, or once every 3 weeks. Part 1: in multiple increasing doses; Part 2: ZW25 given at the MTD, OBD, or an RD identified in Part 1; Part 3: ZW25 given at the MTD, OBD, or an RD combined with one of the following selected drug combination:

DRUG

Paclitaxel

Combination therapy with ZW25 - Part 3 Treatment Groups 1 and 4

DRUG

Capecitabine

Combination therapy with ZW25 - Part 3 Treatment Groups 2 and 5

DRUG

Vinorelbine

Combination therapy with ZW25 - Part 3 Treatment Groups 3 and 6

DRUG

Tucatinib

Combination therapy with ZW25 and Capecitabine - Part 3 Treatment Group 7

DRUG

Tucatinib

Combination therapy with ZW25 - Part 3 Treatment Group 8 (may be opened if recommended by the Safety Monitoring Committee and/or the sponsor)

Trial Locations (17)

13620

Seoul National University Bundang Hospital, Seongnam-si

35294

University of Alabama, Birmingham

37203

Sarah Cannon - Tennessee Oncology, Nashville

60612

Rush University Medical Center, Chicago

77030

MD Anderson Cancer Center, Houston

78229

South Texas Accelerated Research Therapeutics (START), San Antonio

80045

University of Colorado Cancer Center, Aurora

90033

USC/Norris Cancer Center, Los Angeles

92663

Hoag Family Cancer Institute, Newport Beach

98405

Northwest Medical Specialties, Tacoma

K1H 8L6

University of Ottawa, Ottawa

M5G 2M9

Princess Margaret Cancer Centre, Toronto

H3T1E2

Jewish General Hospital, Montreal

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY