A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

August 29, 2019

Primary Completion Date

August 30, 2025

Study Completion Date

August 30, 2025

Conditions
HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
Interventions
DRUG

ZW25 (Zanidatamab)

"* Part 1: administered IV at dose levels and schedules determined by the Safety Monitoring Committee (SMC)~* Part 2: RD identified in Part 1"

DRUG

Capecitabine

Administered orally twice daily (PO bid)

DRUG

Cisplatin

Administered IV

DRUG

Fluorouracil

Administered IV

DRUG

Leucovorin

Administered IV

DRUG

Oxaliplatin

Administered IV

DRUG

Bevacizumab

Administered IV

DRUG

Gemcitabine

Administered IV

Trial Locations (23)

10065

Memorial Sloan Kettering Cancer Center, New York

13620

Seoul National University Bundang Hospital, Seongnam-si

19111

Fox Chase Cancer Center, Philadelphia

33612

H. Lee Moffitt Cancer Center, Tampa

37203

Sarah Cannon Research Institute, Nashville

49241

Pusan National University, Busan

49503

The Cancer and Hematology Centers, Grand Rapids

60637

University of Chicago, Chicago

68114

Nebraska Methodist Hospital, Omaha

77030

MD Anderson Cancer Center, Houston

90033

USC/Norris Comprehensive Cancer Center, Los Angeles

92663

Hoag Memorial Hospital Presbyterian, Newport Beach

98101

Virginia Mason Medical Center, Seattle

7500653

Centro de Investigacion Clinica SAGA, Santiago

8241479

Icegclinic Research & Care, Santiago

8320000

CECIM Biocinetic, Santiago

8420383

Centro Internacional de Estudios Clínicos, Santiago

K1H 8L6

The Ottawa Hospital Cancer Centre, Ottawa

M5G 2C1

Princess Margaret Cancer Center, Toronto

02841

Korea University Anam Hospital, Seoul

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Seoul

05505

Asan Medical Center, Seoul

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY