Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Esophageal Neoplasms

Cholangiocarcinoma

Colorectal Neoplasms

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Intestinal Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Biliary Tract Diseases

Stomach Cancer

Esophageal Cancer

Bile Duct Cancer

Biliary Tract Cancer

Intrahepatic Cholangiocarcinoma

All Drugs and Chemicals

Antineoplastic Agents

Micronutrients

Hematinics

Vitamins

Antibodies

Gemcitabine

Capecitabine

Bevacizumab

Leucovorin

Fluorouracil

Levoleucovorin

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Immunomodulating Agents

Oxaliplatin

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Antibodies, Bispecific

Immunoglobulins

Antineoplastic Agents, Immunological

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Growth Inhibitors

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

ZW25 plus fluorouracil (5-FU) and cisplatin

ZW25 plus 5-FU, leucovorin, and oxaliplatin

ZW25 plus 5-FU, leucovorin, oxaliplatin, and bevacizumab

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

ZW25 (Zanidatamab)

Phillip Garfin, MD, PhD

This is a multicenter, global, Phase 2, open-label, 2-part, first-line study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) plus standard first-line combination chemotherapy regimens for selected gastrointestinal (GI) cancers. Eligible patients include those with unresectable, locally advanced, recurrent or metastatic HER2-expressing gastroesophageal adenocarcinoma (GEA), biliary tract cancer (BTC), or colorectal cancer (CRC).

Part 1 of the study will first evaluate the safety and tolerability of ZW25 plus standard first-line combination chemotherapy (XELOX, FP, or mFOLFOX6 for GEA; mFOLFOX6 with or without bevacizumab for CRC; and CisGem for BTC) and will confirm the recommended dosage (RD) of ZW25 when administered in combination with each of these multi-agent chemotherapy regimens. Then, Part 2 of the study will evaluate the anti-tumor activity of ZW25 plus combination chemotherapy in HER2-expressing GEA, BTC, and CRC.

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

Phase 2 Study of ZW25 Plus First-line Combination Chemotherapy in HER2-Expressing Gastrointestinal (GI) Cancers, Including Gastroesophageal Adenocarcinoma (GEA), Biliary Tract Cancer (BTC), and Colorectal Cancer (CRC)

Number of participants who experienced a DLT. DLTs include adverse events considered to be related to study treatment, including the evaluated dose level of ZW25, any component or combination of the components of a chemotherapy regimen, or the combination of ZW25 plus a chemotherapy regimen.

Number of participants who experienced an adverse event

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

Number of participants who achieved a best response of either complete response (CR) or partial response (PR) during treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Number of participants who achieved a best response of either CR or PR during treatment per RECIST 1.1

Number of participants who achieved a best response of CR, PR, or stable disease (SD) during treatment per RECIST 1.1

Median duration of response (in months) and range (minimum, maximum)

Number of participants with SD for ≥ 24 weeks or a confirmed, best overall response of CR or PR per RECIST 1.1

Median progression-free survival (in months) and range (minimum, maximum)

Median overall survival (in months) and range (minimum, maximum)

Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology and chemistry. Grades are defined using National Cancer Institute's CTCAE, version 5.0.

Jazz Pharmaceuticals

Symptoms and General Pathology

Death

Stomach Diseases

Trastuzumab

Tislelizumab

Trastuzumab (Herceptin®) plus physician's choice of capecitabine plus oxaliplatin (CAPOX) or 5-fluorouracil (5-FU) plus cisplatin (FP)

Zanidatamab plus physician's choice of CAPOX or FP

Zanidatamab and tislelizumab plus physician's choice of CAPOX or FP

Zanidatamab

5-Fluorouracil

Clinical Trial Disclosure & Transparency

Guillermo Mendez, MD

Dolores Gomez Bradley

Martín Paskevicius, MD

Aldo Riso, MD

Jorge Salinas, MD

Susana Kahl, MD

Luisa Susana Medina, MD

Rubén Kowalyszyn, MD

Amitesh Roy, MD, MSc

Niall Tebbutt, BA, BM, BCh, PhD

Weng Ng, MSc, MBBS, PhD

Andrew Kiberu, MBChB

Pieter-Jan Cuyle, MD

Marc Van den Eynde, MD

Karen Geboes, MD

Eric Van Cutsem, MD, PhD

Joelle Collignon, MD

Arinilda Campos Bragagnoli

Kathia Abdalla, MD

Andre Murad, MD, PhD

Patricia Medeiros

Maria Marcela Monteiro

Fabio Franke, MD

Rodrigo Perez Pereira, MD

Katsuki Arima Tiscoski, MD

Luciana Viola, MD

Juliana Janoski de Menezes, MD

Cristiano Duque, MD

Felipe Jose Silva Melo Cruz, MD

Luis Pires, MD, PhD

Camila Moniz, MD

Elena Elimova, MD

Christian Lorenzo Caglevic Medina

Ariel Zwenger, MD

Mauricio Reyes, MD

Pamela Salman, MD

Anrried Escalante, MD

Marco Bernaschina Olivares, MD

Patricio Yanez Weber, MD

Guangyu An

Lin Yang

Lin Shen, MD

Baoshan Cao

Yunbo Zhao

Dong Yan, MD, PhD

Zhengquan Han

Zhenyang Liu

Jun Zhao

Jun Wu

Jingdong Lu

Xi Shi

Rongbo Lin

Yong Li

Yanhong Deng, MD, PhD

Lin Wang

Haiping Jiang

Hongming Pan

Ying Yuan, MD, PhD

Jieer Ying

Yanqiao Zhang

Yifu He, MD, PhD

Zhendong Chen

Wuyun Su

Changzheng Li, MD

Meili Sun

Lin Xie

Xiaoming Hou

Yan Yang

Xiaojun Xiang, MD

Baorui Liu

Wensheng Qiu

Jun Zhang

Tianshu Liu

Xiao Dong Zhu

Qing Xu

Qi Li

Kairong Huang

Xiujuan Qu

Jingdong Zhang

Shubin Wang, MD, PhD

Ruixing Zhang

Diansheng Zhong

Yi Ba

Feng Liu, MD, PhD

Hongyan Xu, MD

Yin Jin, MD

Tao Zhang

Huiting Xu, MD

Yong Mao

Enxiao Li

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).

multi-cohort, open-label, multicenter study

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

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)

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 blinded independent central review (BICR) or death from any cause

The time from randomization to death due to any cause

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

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

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

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

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

Number of subjects who experienced adverse events or serious adverse events

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

Changes from baseline in the EORTC QLQ-C30 scores

Changes from baseline in the EORTC QLQ-OG25 scores

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

BeiGene, Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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	NCT03929666	HER2-expressing...	ZW25 (Zanidatam... Capecitabine Cisplatin Fluorouracil Leucovorin Oxaliplatin Bevacizumab Gemcitabine	18 Years -	Jazz Pharmaceuticals
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	NCT03929666	HER2-expressing...	ZW25 (Zanidatam... Capecitabine Cisplatin Fluorouracil Leucovorin Oxaliplatin Bevacizumab Gemcitabine	18 Years -	Jazz Pharmaceuticals
A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers	NCT05152147	Gastric Neoplas... Gastroesophagea... Esophageal Aden...	Zanidatamab Tislelizumab Trastuzumab Capecitabine Oxaliplatin Cisplatin 5-Fluorouracil	18 Years -	Jazz Pharmaceuticals

Spots Global Cancer Trial Database for fp

Every month we try and update this database with for fp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fp

Every month we try and update this database with for fp cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.