Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Cholangiocarcinoma

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Bile Duct Cancer

Biliary Tract Cancer

Gallbladder Cancer

Intrahepatic Cholangiocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Pembrolizumab

Cisplatin

Durvalumab

Antimetabolites

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Zanidatamab plus standard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations.

Standard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations.

Zanidatamab

Clinical Trial Disclosure & Transparency

The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer.

Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer

An Open-label Randomized Trial of the Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy Alone for Advanced HER2-positive Biliary Tract Cancer

PFS is defined as the time from the date of randomization to the date of documented disease progression, or death from any cause.

OS is defined as the time from randomization to death, due to any cause.

Confirmed objective response rate is defined as achieving a confirmed best overall response of Complete Response (CR) or Partial Response (PR)

Duration of response is defined as the time from the first objective response (CR or PR) to documented Progressive Disease (PD) or death, from any cause.

TDD is defined as the time from randomization to the first confirmed clinical meaningful deterioration or death. European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) final scores range from 0 to 100, where higher scores reflect better functioning

TDD is defined as the time from randomization to the first confirmed clinical meaningful deterioration or death. EORTC QLQ-C30 final scores range from 0 to 100, where higher scores reflect better functioning.

TDD is defined as the time from randomization to the first confirmed clinical meaningful deterioration or death. EORTC Quality of Life Questionnaire - Cholangiocarcinoma and Gallbladder Cancer module (QLQ-BIL21) (Pain, Jaundice, Abdominal Pain, and Pruritis) final scores range from 0 to 100, where higher scores reflect better functioning.

TDD is defined as the time from randomization to the first confirmed clinical meaningful deterioration or death. EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain, and Pruritis) final scores range from 0 to 100, where higher scores reflect better functioning.

Jazz Pharmaceuticals

Evorpacept

This study is being done to find out if zanidatamab when given with evorpacept (ALX148) is safe and can treat patients with advanced (locally advanced \[inoperable\] and/or metastatic) human epidermal growth factor receptor 2 (HER2)-expressing cancer.

Part 1 of the study will first evaluate the safety and tolerability and establish the recommended doses (RDs) of zanidatamab in combination with evorpacept (ALX148). Part 2 of the study will evaluate the anti-tumor activity of the combination of zanidatamab plus evorpacept (ALX148) at the RD levels in indication-specific expansion cohorts.

single-arm, open-label, multi-cohort, multi-center study

A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer

A Phase 1b/2, 2-part Open-label Study to Assess the Safety and Antitumor Activity of Zanidatamab in Combination With ALX148 in Advanced HER2-expressing Cancer

Number of patients who experienced a DLT. DLTs include specifically defined adverse events (AEs) considered to be related to zanidatamab or evorpacept (ALX148), including combination of zanidatamab with evorpacept (ALX148)

Number of patients who experienced AEs, serious adverse events (SAEs), or adverse events of special interest (AESIs)

Number of patients who experienced a 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 (NCI-CTCAE), version 5.0

Number of patients who achieved a confirmed best overall response (BOR) of either complete response (CR) or partial response (PR) during treatment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

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

Number of patients who achieved a SD for ≥ 24 weeks or a confirmed BOR of CR or PR during treatment per RECIST 1.1

The time from the first objective response (CR or PR) to documented progressive disease per RECIST 1.1, clinical progression, or death within 30 days of last dose of study drug (zanidatamab and/or evorpacept \[ALX148\]) from any cause

The time from the first dose of study treatment to the date of documented disease progression (per RECIST 1.1), clinical progression, or death from any cause

Number of patients with a PFS time ≥ 24 weeks

The time from first dose of study treatment until death from any cause

Number of patients who experienced AEs, SAEs, or AESIs

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 NCI-CTCAE, version 5.0

Minimum observed serum concentration (trough)

ALX Oncology Inc.

Antibodies

Immunomodulating Agents

Antibodies, Bispecific

Immunoglobulins

ZW25 (Zanidatamab)

This multicenter, open-label, single-arm trial will evaluate the anti-tumor activity of ZW25 (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2 (HER2)-amplified, inoperable and advanced or metastatic biliary tract cancer (BTC), including intra-hepatic cholangiocarcinoma (ICC), extra-hepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).

single-arm, open-label, multi-cohort, multicenter study

A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers

A Phase 2b, Open-label, Single-arm Study of ZW25 Monotherapy in Subjects With Advanced or Metastatic HER2-amplified Biliary Tract Cancers

Number of subjects who achieved a confirmed best overall response (BOR) of either complete response (CR) or partial response (PR) during treatment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

The time from the first objective response (CR or PR) to documented progressive disease (PD) per RECIST 1.1, clinical progression, or death from any cause

Proportion of subjects with a DOR ≥ 16 weeks per RECIST 1.1

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

Number of subjects who achieved a BOR of either CR or PR during treatment per RECIST 1.1

The time from the first objective response (CR or PR) to documented PD per RECIST 1.1, clinical progression, or death from any cause

Number of subjects who achieved a best response of CR, PR, or SD during treatment per RECIST 1.1

The time from the first dose of study treatment until the date of death from any cause

Number of subjects who experienced AEs or serious adverse events

Number of subjects 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

BeiGene, Ltd.

Symptoms and General Pathology

Esophageal Neoplasms

Death

Adenocarcinoma

Stomach Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Stomach Diseases

Esophageal Cancer

Stomach Cancer

Trastuzumab

Oxaliplatin

Fluorouracil

Capecitabine

Tislelizumab

Immunosuppressive Agents

Immunologic Factors

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

5-Fluorouracil

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer	NCT06282575	Biliary Tract C... HER2 Gene Mutat...	Zanidatamab Cisplatin Gemcitabine Pembrolizumab Durvalumab	18 Years -	Jazz Pharmaceuticals
A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer	NCT05027139	HER2-expressing...	Zanidatamab Evorpacept	18 Years -	Jazz Pharmaceuticals
A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer	NCT05027139	HER2-expressing...	Zanidatamab Evorpacept	18 Years -	Jazz Pharmaceuticals
A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers	NCT04466891	HER2-amplified ...	ZW25 (Zanidatam...	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
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer	NCT06282575	Biliary Tract C... HER2 Gene Mutat...	Zanidatamab Cisplatin Gemcitabine Pembrolizumab Durvalumab	18 Years -	Jazz Pharmaceuticals

Spots Global Cancer Trial Database for jzp598

Every month we try and update this database with for jzp598 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 jzp598

Every month we try and update this database with for jzp598 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 jzp598 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.