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

Cisplatin

Immunomodulating Agents

Oxaliplatin

Folic Acid

Antibodies, Bispecific

Immunoglobulins

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

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

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Pancreatic Cancer

BOLD-100 in combination with FOLFOX Chemotherapy (Dose Expansion)

320 mg/m2 IV over 30 minutes, q2weeks; 420 mg/m2 IV over 30 minutes, q2weeks; 500 mg/m2 IV over 30 minutes, q2weeks; 625 mg/m2 IV over 30 minutes, q2weeks

BOLD-100 in combination with FOLFOX Chemotherapy (Dose Escalation)

BOLD-100 is an intravenously administered sterile solution containing the ruthenium-based small molecule. BOLD-100 has been shown to preferentially decrease the expression of GRP78 in tumour cells and ER stressed cells when compared to normal cells. BOLD-100 will be combined with cytotoxic FOLFOX chemotherapy in this study, with a dose escalation cohort to ensure tolerability and safety, followed by a cohort expansion phase.

BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours

A Phase 1b/2a Dose Escalation Study of BOLD-100 in Combination With FOLFOX Chemotherapy in Patients With Advanced Solid Tumours

Bold Therapeutics, Inc.

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Breast Neoplasms

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

* Dose Escalation: ZW49 administered intravenously at dose levels determined by the SMC
* Expansion: MTD or RD identified in the dose-escalation part of the study

ZW49

Joseph Woolery, PharmD, BCOP

This is a first-in-human, Phase 1, multicenter, open-label, dose-escalation study to establish the maximum-tolerated dose (MTD) or recommended dosage (RD) of ZW49, the investigational agent under study, and to assess the safety and tolerability of ZW49. Eligible patients include those with locally advanced (unresectable) or metastatic HER2-expressing cancers.

The study will use a 3+3 dose-escalation study design to evaluate the safety and tolerability of ZW49 and to determine the MTD or RD of ZW49 for further study. Selected expansion cohorts will be subsequently opened based upon Safety Monitoring Committee (SMC) recommendation and sponsor approval to further evaluate the safety and tolerability of ZW49 at the MTD or RD and to assess preliminary anti-tumor activity.

A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers

A Phase 1 Study of ZW49 in Patients With Locally Advanced (Unresectable) or Metastatic HER2-Expressing Cancers

Number of participants who experienced a DLT. DLTs are events that occur following administration of any amount of ZW49 and are considered related to ZW49 per the investigator. DLTs will include only events considered related to ZW49.

Number of participants who experienced an abnormal ECG or LVEF

Number of doses reduced and number of participants who require a dose reduction

End of infusion concentration, maximum serum concentration, and trough concentration of ZW49

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

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

Zymeworks BC Inc.

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

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
BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours	NCT04421820	Colorectal Canc... Pancreatic Canc... Gastric Cancers Cholangiocarcin...	BOLD-100 in com... BOLD-100 in com...	18 Years -	Bold Therapeutics, Inc.
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 Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers	NCT03821233	HER2-expressing...	ZW49	18 Years -	Zymeworks BC Inc.
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

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