HERIZON-GEA-01: A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers

• Sponsor: Zymeworks Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05152147
• Collaborator: BeiGene, Ltd. (Other)
• Enrollment: 714
• Locations: 294
• Arms: 3
• Anticipated Duration (Months): 42.9
• Patients Per Site: 2.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy.

The patients in this study will have advanced human epidermal growth factor 2 (HER2)-positive stomach and esophageal cancers that are no longer treatable with surgery (unresectable) or chemoradiation, and/or have grown or spread to other parts of the body (metastatic).

Condition or Disease	Intervention/Treatment	Phase
Gastric Neoplasms; Gastroesophageal Adenocarcinoma; Esophageal Adenocarcinoma	Drug: Zanidatamab; Drug: Tislelizumab; Drug: Trastuzumab; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Cisplatin; Drug: 5-Fluorouracil; Diagnostic Test: In situ hybridization (ISH)-based companion diagnostic assay; Diagnostic Test: Immunohistochemistry (IHC)-based companion diagnostic assay	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 714 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: multi-cohort, open-label, multicenter studymulti-cohort, open-label, multicenter study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination With Chemotherapy With or Without Tislelizumab in Subjects With HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA)
• Actual Study Start Date: Dec 2, 2021
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm A Trastuzumab (Herceptin®) plus physician's choice of capecitabine plus oxaliplatin (CAPOX) or 5-fluorouracil (5-FU) plus cisplatin (FP)	Drug: Trastuzumab; Administered intravenously (IV); Other Names: Herceptin® ; Drug: Capecitabine; Administered orally (PO bid); Drug: Oxaliplatin; Administered IV; Drug: Cisplatin; Administered IV; Drug: 5-Fluorouracil; Administered IV; Diagnostic Test: In situ hybridization (ISH)-based companion diagnostic assay; Subjects will be tested for HER2 gene-amplification using the ISH-based companion diagnostic assay; Diagnostic Test: Immunohistochemistry (IHC)-based companion diagnostic assay; Subjects will be tested for HER2 protein-expression using the IHC-based companion diagnostic assay
Experimental: Arm B Zanidatamab plus physician's choice of CAPOX or FP	Drug: Zanidatamab; Administered IV; Other Names: ZW25 ; Drug: Capecitabine; Administered orally (PO bid); Drug: Oxaliplatin; Administered IV; Drug: Cisplatin; Administered IV; Drug: 5-Fluorouracil; Administered IV; Diagnostic Test: In situ hybridization (ISH)-based companion diagnostic assay; Subjects will be tested for HER2 gene-amplification using the ISH-based companion diagnostic assay; Diagnostic Test: Immunohistochemistry (IHC)-based companion diagnostic assay; Subjects will be tested for HER2 protein-expression using the IHC-based companion diagnostic assay
Experimental: Arm C Zanidatamab and tislelizumab plus physician's choice of CAPOX or FP	Drug: Zanidatamab; Administered IV; Other Names: ZW25 ; Drug: Tislelizumab; Administered IV; Drug: Capecitabine; Administered orally (PO bid); Drug: Oxaliplatin; Administered IV; Drug: Cisplatin; Administered IV; Drug: 5-Fluorouracil; Administered IV; Diagnostic Test: In situ hybridization (ISH)-based companion diagnostic assay; Subjects will be tested for HER2 gene-amplification using the ISH-based companion diagnostic assay; Diagnostic Test: Immunohistochemistry (IHC)-based companion diagnostic assay; Subjects will be tested for HER2 protein-expression using the IHC-based companion diagnostic assay

Outcome Measures

Primary Outcome Measures

1. Progression-free survival (PFS) by blinded independent central review (BICR) [Up to 2.5 years]

   The time from randomization to the date of documented disease progression (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) as assessed by BICR or death from any cause

2. Overall survival [Up to 3.5 years]

   The time from randomization to death due to any cause

Secondary Outcome Measures

1. Confirmed objective response rate (ORR) by BICR [Up to 2.5 years]

   Number of patients who achieved a best overall response of complete response (CR) or (PR) as determined per RECIST 1.1 as assessed by BICR

2. Duration of response (DOR) by BICR [Up to 2.5 years]

   The time from the first objective response (CR or PR) per BICR to documented progressive disease per RECIST 1.1 as assessed by BICR or death from any cause

3. PFS per Investigator assessment [Up to 2.5 years]

   The time from randomization to the date of documented disease progression (per RECIST 1.1) as assessed by Investigator or death from any cause

4. ORR per Investigator assessment [Up to 2.5 years]

   Number of patients who achieved a best overall response of CR or PR as determined per RECIST 1.1 as assessed by Investigator

5. DOR per Investigator assessment [Up to 2.5 years]

   The time from the first objective response (CR or PR) per Investigator to documented progressive disease per RECIST 1.1 as assessed by Investigator or death from any cause

6. Incidence of adverse events [Up to 2 years]

   Number of subjects who experienced adverse events or serious adverse events

7. Incidence of clinical laboratory abnormalities [Up to 2 years]

   Number of patients who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0

8. Health-related quality of life (HRQoL) as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (core cancer questionnaire) C30 (QLQ-C30) [Up to 2.5 years]

   Changes from baseline in the EORTC QLQ-C30 scores

9. HRQoL as assessed by the EORTC Quality of Life Questionnaire (oesophago-gastric module) OG25 (QLQ-OG25) [Up to 2.5 years]

   Changes from baseline in the EORTC QLQ-OG25 scores

10. HRQoL as assessed by the EuroQol 5-dimensions 5-levels (EQ-5D-5L) questionnaire [Up to 2.5 years]

    Changes from baseline in the EORTC EQ-5D-5L questionnaire scores

11. Serum concentration of zanidatamab, tislelizumab, and trastuzumab [Up to 2 years]

12. Incidence of anti-drug antibodies (ADAs) [Up to 2 years]

    Number of patients who develop ADAs

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically confirmed unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment. Subjects with esophageal adenocarcinoma must not be eligible for combined chemoradiotherapy at the time of enrollment

• Assessable (measurable or non-measurable) disease as defined by RECIST 1.1

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, assessed within 3 days prior to randomization

• Adequate organ function

• Left ventricular ejection fraction (LVEF) ≥ 50% as determined by either echocardiogram or multiple gated acquisition scan (MUGA)

Exclusion Criteria:

• Prior treatment with a HER2-targeted agent, with the exception of subjects who received HER2-targeted treatment for breast cancer > 5 years prior to initial diagnosis of GEA

• Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

• Prior treatment with systemic antineoplastic therapy for unresectable locally advanced, recurrent or metastatic GEA

• Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks prior to randomization. Stable, treated brain metastases are allowed (defined as subjects who are off steroids and anticonvulsants and are neurologically stable with no evidence of radiographic progression for at least 4 weeks prior to randomization)

• Known history of or ongoing leptomeningeal disease (LMD)

• Known additional malignancy that is not considered cured or that has required treatment within the past 3 years

• Known active hepatitis

• Any history of human immunodeficiency virus (HIV) infection

• Known SARS-CoV-2 infection; subjects with prior infection that has resolved per local institutions' requirements and screening guidance are eligible

• QTc Fridericia (QTcF) > 470 ms

• Clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension or any history of symptomatic congestive heart failure (CHF)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto de Investigaciones Metabólicas - IDIM	Ciudad Autónoma de Buenos Aires		Argentina	C1012
2	Fundación Centro de Medicina Nuclear y Molecular ER	Córdoba		Argentina	X5000HXL
3	Centro Médico Privado CEMAIC	Córdoba		Argentina	X5008HHW
4	Research Site	Parque Patricios		Argentina
5	Centro de Investigación Pergamino S.A.	Pergamino		Argentina	2700
6	Centro de Investigaciones Médicas Tucumán	San Miguel De Tucumán		Argentina	T4000AXL
7	Research Site	Viedma		Argentina
8	Border Medical Oncology Research Unit	Albury		Australia	2640
9	Flinders Medical Centre	Bedford Park		Australia	5042
10	Austin Health	Heidelberg		Australia	3084
11	Liverpool Hospital	Liverpool		Australia	2170
12	Fiona Stanley Hospital	Murdoch		Australia	6150
13	Imelda VZW	Bonheiden		Belgium	2820
14	Cliniques Universitaires Saint-Luc	Brussels		Belgium	1200
15	UZ Gent	Gent		Belgium	9000
16	UZ Leuven	Leuven		Belgium	3000
17	Research Site	Liège		Belgium
18	Research Site 1	Barretos		Brazil
19	Research Site 2	Barretos		Brazil
20	Research Site	Belo Horizonte		Brazil
21	Research Site	Brasília		Brazil
22	Research Site	Fortaleza		Brazil
23	Research Site	Ijuí		Brazil
24	Research Site 1	Porto Alegre		Brazil
25	Research Site 2	Porto Alegre		Brazil
26	Research Site 3	Porto Alegre		Brazil
27	Research Site 4	Porto Alegre		Brazil
28	Research Site	Rio De Janeiro		Brazil
29	Research Site	Santo André		Brazil
30	Research Site	Sorocaba		Brazil
31	Research Site	São Paulo		Brazil
32	Research Site	Toronto		Canada
33	Corporacion de Beneficencia Osorno	Osorno		Chile	5290000
34	Centro de Estudios Clínicos SAGA SpA	Providencia		Chile	7500000
35	Research Site	Providencia		Chile
36	Meditek Ltda	Recoleta		Chile	8420000
37	Sociedad Oncovida S.A	Santiago		Chile	7500000
38	Icegclinic	Santiago		Chile	8150513
39	BIOCINETIC SpA	Santiago		Chile	8330336
40	Sociedad de Investigaciones Medicas Limitada	Temuco		Chile	4810469
41	Beijing Chao-Yang Hospital, Capital Medical University	Beijing		China	100020
42	Beijing Tiantan Hospital, Capital Medical University	Beijing		China	100050
43	Beijing Cancer Hospital	Beijing		China	100142
44	Peking University Third Hospital	Beijing		China	100191
45	Beijing Luhe Hospital, Capital Medical University	Beijing		China	101199
46	Research Site 1	Beijing		China
47	Research Site 2	Beijing		China
48	Research Site 3	Beijing		China
49	The First Affiliated Hospital of Bengbu Medical College	Bengbu		China	233004
50	Research Site	Changchun		China
51	Hunan Cancer Hospital	Changsha		China	410031
52	Changzhi People Hospital	Changzhi		China	046099
53	Research Site	Changzhou		China
54	Sichuan Cancer Hospital & Institute	Chengdu		China	610042
55	Foshan First People's Hospital	Foshan		China	528000
56	The First Affiliated Hospital of Fujian Medical University	Fuzhou		China	350005
57	Fujian Cancer Hospital	Fuzhou		China	350014
58	Guangdong Provincial People's Hospital	Guangzhou		China	510055
59	The Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou		China	510655
60	Hainan General Hospital	Haikou		China	570311
61	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou		China	310016
62	Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou		China	310017
63	Zhejiang Cancer Hospital	Hangzhou		China	310022
64	Research Site	Hangzhou		China
65	Harbin Medical University Cancer Hospital	Harbin		China	150081
66	Anhui Provincial Cancer Hospital	Hefei		China	230031
67	The Second Affiliated Hospital of Anhui Medical University	Hefei		China	230601
68	Research Site	Hohhot		China
69	Shandong Cancer Hospital	Jinan		China	250000
70	Jinan Cancer Hospital	Jinan		China	250013
71	Research Site	Jining		China
72	Yunnan Cancer Hospital	Kunming		China	650118
73	The First Hospital of Lanzhou University	Lanzhou		China	730013
74	Gansu Provincial Cancer Hospital	Lanzhou		China	730050
75	The First Affiliated Hospital of Nanchang University	Nanchang		China	330052
76	Nanjing Drum Tower Hospital ,The Affiliated Hospital of Nanjing University Medical School	Nanjing		China	210008
77	The Affiliated Hospital of Qingdao University	Qingdao		China	266003
78	Ruijin hospital Shanghai Jiao Tong University School of Medicine	Shanghai		China	200025
79	Fudan University Affiliated Zhongshan Hospital	Shanghai		China	200032
80	Shanghai East Hospital	Shanghai		China	200120
81	Research Site 1	Shanghai		China
82	Research Site 2	Shanghai		China
83	Research Site 3	Shanghai		China
84	Research Site	Shangrao		China
85	Liaoning Cancer Hospital & Institute	Shenyang		China	110801
86	Research Site 1	Shenyang		China
87	Peking University Shenzhen Hospital	Shenzhen		China	518035
88	Research Site	Shenzhen		China
89	The Fourth Hospital of Hebei Medical University	Shijiazhuang		China	50011
90	Tianjin Medical University General Hospital	Tianjin		China	300041
91	Tianjin Medical University Cancer Institute & Hospital	Tianjin		China	300060
92	The Tonghua Central Hospital	Tonghua		China	143099
93	Weihai Municipal Hospital	Weihai		China	264200
94	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou		China	325000
95	Union Hospital Tongji Medical College HuaZhong University of Science and Technology	Wuhan		China	430023
96	Hubei Cancer Hospital	Wuhan		China	430079
97	Affiliated Hospital of Jiangnan University	Wuxi		China	214062
98	First Affiliated Hospital of Xi 'an Jiaotong University	Xi'an		China	710061
99	Research Site	Xi'an		China
100	Research Site	Xiamen		China
101	Northern Jiangsu People's Hospital	Yangzhou		China	225001
102	Research Site	Yangzhou		China
103	Henan Cancer Hospital	Zhengzhou		China	450003
104	The First Affiliated Hospital of Zhengzhou University	Zhengzhou		China	450052
105	Research Site	Zhengzhou		China
106	Cancer Hospital affiliated to Xinjiang Medical University	Ürümqi		China	830026
107	Fakultni nemocnice Olomouc	Hradec Králové		Czechia	500 05
108	East Tallinn Central Hospital	Tallinn		Estonia	11312
109	North Estonia Medical Centre Foundation	Tallinn		Estonia	13419
110	Institut Sainte Catherine	Avignon		France	84000
111	Hopital Jean Minjoz	Besançon		France	25030
112	EDOG - Institut Bergonie - PPDS	Bordeaux		France	33000
113	Universite de Bourgogne - Faculte de Medecine - IN	Dijon		France	21079
114	Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon	Grenoble		France	38043
115	Research Site	Lyon		France
116	Research Site	Nantes		France
117	CHRU de Poitiers La Miletrie	Poitiers		France	86021
118	EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS	Rennes		France	35000
119	CHRU de Brest - Hopital Morvan	Saint-Priest-en-Jarez		France	42270
120	Hôpital de Rangueil	Toulouse		France	69437
121	Hôpital Saint Antoine	Villejuif		France	94800
122	Research Site 1	Tbilisi		Georgia
123	Research Site 2	Tbilisi		Georgia
124	Research Site 3	Tbilisi		Georgia
125	Research Site 4	Tbilisi		Georgia
126	Research Site	Frankfurt am Main		Germany
127	Research Site	Hannover		Germany
128	Research Site	Leipzig		Germany
129	Research Site	Trier		Germany
130	Research Site	Ulm		Germany
131	Aretaieio Hospital of Athens	Athens		Greece	115 28
132	Attikon University General Hospital	Athens		Greece	124 64
133	Research Site	Piraeus		Greece
134	Bioclinic Thessaloniki Oncology Department	Thessaloniki		Greece	54622
135	Agios Loucas Clinic SA	Thessaloniki		Greece	552 36
136	Interbalkan Medical Center of Thessaloniki Oncology Department	Thessaloniki		Greece	57001
137	Celan S.A.	Guatemala City		Guatemala	01010
138	Integra Cancer Institute	Guatemala City		Guatemala	01010
139	Grupo Medico Angeles	Guatemala City		Guatemala	01015
140	Centro Medico Integral de Cancerologia CEMIC	Salcaja		Guatemala	09002
141	Research Site	Hong Kong		Hong Kong
142	Research Site	Kowloon		Hong Kong
143	Research Site	Bangalore		India
144	Research Site	Bhubaneswar		India
145	Research Site	Gurgaon		India
146	Research Site	Hyderabad		India
147	Research Site	Jaipur		India
148	Research Site	Nashik		India
149	Research Site	New Delhi		India
150	Research Site	Patna		India
151	Research Site	Pune		India
152	Research Site	Vijayawada		India
153	Research Site	Dublin		Ireland
154	Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi	Bologna		Italy	40138
155	Fondazione del Piemonte per l'Oncologia (IRCCS)	Candiolo		Italy	10060
156	Research Site	Genova		Italy
157	Research Site	Meldola		Italy
158	Research Site 1	Milano		Italy
159	Research Site 2	Milano		Italy
160	Research Site 3	Milano		Italy
161	Research Site	Modena		Italy
162	Research Site	Reggio Emilia		Italy
163	Fondazione Policlinico Universitario A Gemelli	Rome		Italy	00168
164	Research Site	Torino		Italy
165	Centro Ricerche Cliniche Di Verona	Verona		Italy	37134
166	Azienda ULSS 8 "Berica" - Ospedale San Bortolo	Vicenza		Italy	36100
167	Hallym University Sacred Heart Hospital	Anyang-si		Korea, Republic of	14068
168	Dong-A University Hospital	Busan		Korea, Republic of	49201
169	Kyungpook National University Chilgok Hospital	Daegu		Korea, Republic of	41404
170	National Cancer Center	Goyang-si		Korea, Republic of	10408
171	Gachon University Gil Medical Center	Incheon		Korea, Republic of	21565
172	CHA Bundang Medical Center, CHA University	Seongnam-si		Korea, Republic of	13496
173	Seoul National University Bundang Hospital	Seongnam-si		Korea, Republic of	13620
174	Korea University Anam Hospital	Seoul		Korea, Republic of	02841
175	Seoul National University Hospital	Seoul		Korea, Republic of	03080
176	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul		Korea, Republic of	03080
177	Kangbuk Samsung Hospital	Seoul		Korea, Republic of	03181
178	Severance Hospital Yonsei University Health System - PPDS	Seoul		Korea, Republic of	03686
179	Asan Medical Center	Seoul		Korea, Republic of	05505
180	Gangnam Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	06229
181	Samsung Medical Center	Seoul		Korea, Republic of	06351
182	Korea University Guro Hospital	Seoul		Korea, Republic of	08308
183	Research Site	George Town		Malaysia
184	Research Site 1	Kuala Lumpur		Malaysia
185	Research Site 2	Kuala Lumpur		Malaysia
186	Research Site	Kuching		Malaysia
187	Research Site	Putrajaya		Malaysia
188	Cryptex Investigación Clínica, S.A. de C.V.	Mexico City		Mexico	06100
189	Research Site 1	Mexico City		Mexico
190	Research Site 2	Mexico City		Mexico
191	Hospital Universitario Dr. Jose Eleuterio González	Monterrey		Mexico	64460
192	Centro de Investigacion Clinica de Oaxaca	Oaxaca		Mexico	68020
193	Research Site	Eindhoven		Netherlands
194	Universitair Medisch Centrum Groningen	Groningen		Netherlands	9713 GZ
195	Research Site	Leiden		Netherlands
196	ETZ-Elisabeth	Tilburg		Netherlands	5042 AD
197	Research Site	Arequipa		Peru
198	Research site	Bellavista		Peru
199	Research Site	Chiclayo		Peru
200	Research Site	Jesús María		Peru
201	Research Site 1	Lima		Peru
202	Research Site 2	Lima		Peru
203	Research Site 3	Lima		Peru
204	Research Site 4	Lima		Peru
205	Research Site	Santiago de Surco		Peru
206	Research Site 1	Trujillo		Peru
207	Research Site 2	Trujillo		Peru
208	Centrum Medyczne Poznan - PRATIA - PPDS	Skórzewo		Poland	60-185
209	Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi	Łódź		Poland	93-513
210	Hospital Garcia de Orta	Almada		Portugal	2801-951
211	Centro Hospitalar E Universitário de Coimbra EPE	Coimbra		Portugal	3000-459
212	Hospital Senhora da Oliveira - Guimaraes, E.P.E	Guimarães		Portugal	4830-044
213	Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria	Lisboa		Portugal	1649-035
214	Hospital Beatriz Angelo	Loures		Portugal	2674-514
215	Unidade Local de Saúde de Matosinhos SA	Matosinhos		Portugal	4454-509
216	Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS	Porto		Portugal	4200-072
217	Research Site 1	Porto		Portugal
218	Research Site 2	Porto		Portugal
219	Fundeni Clinical Institute	București		Romania	022328
220	Cardiomed SRL	Cluj-Napoca		Romania	400015
221	Prof Dr I Chiricuta Institute of Oncology - PPDS	Cluj-Napoca		Romania	400015
222	Medisprof SRL	Cluj-Napoca		Romania	400641
223	Onco Clinic Consult SA	Craiova		Romania	200094
224	Oncology Center Sfantul Nectarie	Craiova		Romania	200347
225	Institutul Regional de Oncologie Iasi	Iasi		Romania	700483
226	Research Site 1	Belgrade		Serbia
227	Research Site 2	Belgrade		Serbia
228	Research Site 3	Belgrade		Serbia
229	Research Site 4	Belgrade		Serbia
230	Research site	Niš		Serbia
231	Research Site	Sremska Kamenica		Serbia
232	Research site 1	Singapore		Singapore
233	Research site 2	Singapore		Singapore
234	Cape Town Oncology Trials	Cape Town		South Africa	7570
235	Research site	Mogale City		South Africa
236	Wilgers Oncology Centre	Pretoria		South Africa	0184
237	Research site	Pretoria		South Africa
238	Corporacio Sanitaria Parc Tauli	Sabadell	Barcelona	Spain	08208
239	Complejo Hospitalario de Navarra	Pamplona	Navarra	Spain	31008
240	Hospital Universitario Germans Trias i Pujol	Badalona		Spain	8915
241	Hospital Universitario Vall d'Hebron - PPDS	Barcelona		Spain	08035
242	Hospital Universitari de Girona Dr Josep Trueta	Girona		Spain	17007
243	ICO l'Hospitalet - Hospital Duran i Reynals	L'Hospitalet de Llobregat		Spain	08908
244	Hospital Universitario Ramon y Cajal	Madrid		Spain	28034
245	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
246	Hospital Universitario La Paz - PPDS	Madrid		Spain	28046
247	Hospital Regional Universitario de Malaga - Hospital General	Málaga		Spain	29010
248	Complejo Asistencial Universitario de Salamanca - H. Clinico	Salamanca		Spain	32911
249	Hospital Universitario Marques de Valdecilla	Santander		Spain	39008
250	Hospital Universitario Virgen Macarena	Sevilla		Spain	41009
251	Hospital Clinico Universitario de Valencia	Valencia		Spain	46010
252	Hospital Universitario Miguel Servet	Zaragoza		Spain	50009
253	China Medical University Hospital	Taichung		Taiwan	404472
254	Chi Mei Medical Center	Tainan		Taiwan	71004
255	Mackay Memorial Hospital	Taipei		Taiwan	104
256	Taipei Veterans General Hospital	Taipei		Taiwan	11217
257	Research site	Bangkok Noi		Thailand
258	Research Site 1	Bangkok		Thailand
259	Research Site 2	Bangkok		Thailand
260	Research site	Hat Yai		Thailand
261	Research Site	Khon Kaen		Thailand
262	Research site	Lak Si		Thailand
263	Research site 1	Phitsanulok		Thailand
264	Research site 2	Phitsanulok		Thailand
265	Research site	Antalya		Turkey
266	Research site	Balçova		Turkey
267	Research site	Bursa		Turkey
268	Research site	Denizli		Turkey
269	Research site	Edirne		Turkey
270	Research site	Fatih		Turkey
271	Research site	Sur		Turkey
272	Research site	Tarabya		Turkey
273	Research site	Trabzon		Turkey
274	Research site	Yenimahalle		Turkey
275	Research site	Çankaya		Turkey
276	Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS	Dnipropetrovsk		Ukraine	49102
277	Communal Non-profit Enterprise Regional Center of Oncology	Kharkiv		Ukraine	61070
278	MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council	Kryvyi Rih		Ukraine	50048
279	Medical Center of Limited Liability Company "Medical center "VERUM EXPERT"	Kyiv		Ukraine	03039
280	Treatment and Diagnostic Center of LLC Specialized Clinic Prognosis Optima	Kyiv		Ukraine	03126
281	SI "National Institute of Surgery and Transplantology n.a. O.O. Shalimov " of NAMS of Ukraine	Kyiv		Ukraine	03680
282	Communal Nonprofit Enterprise Kyiv City Clinical Oncological Center	Kyiv		Ukraine	3115
283	The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council	Lutsk		Ukraine	43018
284	Municipal Non-profit Enterprise "Odessa Regional Oncology Dispensary" of Odesa RC	Odesa		Ukraine	65055
285	Bristol Haematology and Oncology Centre	Bristol		United Kingdom	BS2 8ED
286	Research site	Edgbaston		United Kingdom
287	Western General Hospital Edinburgh - PPDS	Edinburgh		United Kingdom	EH4 2XU
288	St James University Hospital	Leeds		United Kingdom	LS9 7TF
289	Research site 1	London		United Kingdom
290	Research site 2	London		United Kingdom
291	Research site 3	London		United Kingdom
292	Research site	Northwood		United Kingdom
293	Edith Cavell Hospital	Peterborough		United Kingdom	PE3 9GZ
294	Research site	Sheffield		United Kingdom

Sponsors and Collaborators

• Zymeworks Inc.
• BeiGene, Ltd.

Investigators

• Study Director: Jonathan Grim, MD, PhD, Zymeworks Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zymeworks Inc.
• ClinicalTrials.gov Identifier: NCT05152147
• Other Study ID Numbers: ZWI-ZW25-301; 2021-000296-36
• First Posted: Dec 9, 2021
• Last Update Posted: Aug 11, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Zymeworks Inc.: HER2; Bispecific antibody; Biparatopic antibody; Immunotherapy; Gastric cancers; Esophageal cancers; Chemotherapy; FP; Capecitabine; Cisplatin; 5-FU; Oxaliplatin; Gastroesophageal adenocarcinoma; CAPOX; Programmed cell death receptor 1 (PD-1); Anti-PD-1; Anti PD-1
• Additional relevant MeSH terms: Adenocarcinoma; Stomach Neoplasms; Fluorouracil; Capecitabine; Oxaliplatin; Trastuzumab

Study Results

No Results Posted as of Aug 11, 2022