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

Skin and Connective Tissue Diseases

Breast Neoplasms

Adenocarcinoma

Stomach Neoplasms

Breast Diseases

Skin Diseases

Stomach Cancer

Docetaxel

Oxaliplatin

Antibodies

Capecitabine

Tislelizumab

Antibodies, Bispecific

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

ZW25 intravenous (IV) infusion followed by docetaxel IV infusion first-line therapy once every three weeks (Q3W) in female participants with metastatic breast cancer

ZW25 intravenous (IV) infusion followed by tiselizumab IV infusion and CAPOX chemotherapy (oral capecitabine + IV oxaliplatin) first-line therapy once every three weeks (Q3W) in participants with metastatic gastric / GEJ adenocarcinoma

Administered as specified in the treatment arm

ZW25

Study Director

The purpose of the study is to assess the safety, tolerability and preliminary antitumor activity of ZW25 in combination with docetaxel in participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer, and ZW25 in combination with tislelizumab and chemotherapy in participants with HER2-positive gastric/gastroesophageal Junction (GEJ) adenocarcinoma

Anti-HER2 Bispecific Antibody ZW25 Activity in Combination With Chemotherapy With/Without Tislelizumab

Phase 1b/2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-HER2 Bispecific Antibody ZW25 in Combination With Chemotherapy With/Without Tislelizumab in Patients With Advanced HER2-positive Breast Cancer or Gastric/Gastroesophageal Junction Adenocarcinoma

Defined as the proportion of participants who had a best overall response of complete response or partial response per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

Time from the start date of study drug to the first determination of an objective response by investigator per RECIST Version 1.1

Proportion of participants with best overall response of complete response, partial response, and stable disease by investigator per RECIST Version 1.1

Time from the start date of study drug to the date of death due to any cause

BeiGene

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinosarcoma

Mixed Tumor, Mullerian

Endometrial Neoplasms

Adenoma, Pleomorphic

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms by Histologic Type

Sarcoma

Neoplasms, Connective and Soft Tissue

Malignant Mixed Mullerian Tumor

Soft Tissue Sarcoma

Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy. 16 participants will be accrued. If 2 or greater responses are seen, Stage 2 will accrue additional participants.

If 2 or greater responses are seen during Stage 1, Stage 2 will accrue an additional 9 participants. Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy.

ZW25 at 20mg/kg intravenously (IV) every two weeks.

Vikky Makker, MD

This study is being done to test the drug ZW25 and look at whether this drug is effective in women with HER2-overexpressed endometrial cancer or carcinosarcoma that has been treated in the past.

The study will be conducted in two stages. Stage 1 will accrue 16 patients and if two or greater responses are seen, Stage 2 will accrue an additional 9 patients.

ZW25 in Women With Endometrial Cancers

A Phase 2 Trial of ZW25 in HER2 Overexpressed Advanced Endometrial Cancers and Carcinosarcomas (ZW25-IST-2)

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

ORR = Compete Response (CR) + Partial Response (PR) by RECIST v 1.1 \</= 24 weeks from the start of treatment

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
Anti-HER2 Bispecific Antibody ZW25 Activity in Combination With Chemotherapy With/Without Tislelizumab	NCT04276493	Breast Cancer Gastric Cancer Gastroesophagea...	ZW25 Docetaxel Tislelizumab Capecitabine Oxaliplatin	18 Years -	BeiGene
ZW25 in Women With Endometrial Cancers	NCT04513665	Endometrial Can... Carcinosarcoma	ZW25	18 Years -	Memorial Sloan Kettering Cancer Center
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 zw25

Every month we try and update this database with for zw25 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 zw25

Every month we try and update this database with for zw25 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 zw25 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.