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

STATUS

Recruiting
End date

Aug 31, 2025
participants needed

50
sponsor

BeiGene

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Updated on 19 February 2024

See if I qualify

cancer

drug evaluation

breast cancer

epidermal growth factor receptor

measurable disease

metastasis

docetaxel

glomerular filtration rate

growth factor

oxaliplatin

adenocarcinoma

ejection fraction

human epidermal growth factor

cancer treatment

capecitabine

adenocarcinoma of the breast

gastric cancer

gastric adenocarcinoma

metastatic adenocarcinoma

drug test

epidermal growth factor

cancer therapy

erbb2

cytotoxic chemotherapy

recurrent disease

adenocarcinoma of the gastroesophageal junction

her1

bispecific antibody

tislelizumab

breast cancer, treatment

HER2

EGFR

Summary

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

Details

Condition	Breast Cancer, Breast Cancer, Gastropathy, Gastric Cancer, Gastric Cancer, Gastroesophageal Junction Cancer
Age	18years - 100years
Treatment	Capecitabine, ZW25, tislelizumab, Oxaliplatin, Docetaxel
Clinical Study Identifier	NCT04276493
Sponsor	BeiGene
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Disease diagnosis and prior treatment
	Cohort 1 (the first-line breast cancer treatment cohort)
	Female participants with histologically or cytologically confirmed unresectable, locally advanced, recurrent or metastatic adenocarcinoma of the breast and candidate for chemotherapy. Locally recurrent disease must not be amenable to resection with curative intent
	Human epidermal growth factor receptor 2 (HER2) IHC 3+ or in situ hybridization positive on the archival tumor tissue or fresh biopsy sample
	Have not received previous systemic anticancer therapy for locally advanced unresectable or metastatic disease
	Cohort 2 (the first-line gastric/gastroesophageal junction adenocarcinoma treatment cohort)
	Histologically or cytologically confirmed unresectable, locally advanced, recurrent or metastatic adenocarcinoma of the stomach or gastroesophageal junction
	HER2 IHC 3+ or HER2 IHC 2+ together with in situ hybridization positive on the archival tumor tissue or fresh biopsy sample
	Have not received previous systemic anticancer therapy for locally advanced unresectable or metastatic disease, including any approved or investigational estimated glomerular filtration rate (EGFR) or anti-HER2 agents or vaccines, cytotoxic chemotherapy or checkpoint inhibitors
	At least 1 measurable lesion as defined per RECIST Version 1.1
	Eastern Cooperative Oncology Group (ECOG) Performance Status 1
	Adequate organ function as indicated by the following laboratory values during
	screening
	Left ventricular ejection fraction (LVEF) 50% at baseline as determined by either echocardiogram or multigated acquisition scan (MUGA) (echocardiogram is the preferred method) within 28 days before the first dose of study drug
Exclusion Criteria
	Prior therapy 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
	History of approved or investigative tyrosine kinase/HER inhibitors in any treatment setting
	except trastuzumab with or without pertuzumab used in neoadjuvant or adjuvant setting for Cohort 1
	Active leptomeningeal disease or uncontrolled brain metastasis. Participants with equivocal findings or with confirmed brain metastases are eligible for enrollment provided that they are asymptomatic and radiologically stable without the need for corticosteroid treatment for 4 weeks before the first dose of study drug
	Any active malignancy 2 years before the first dose of study drug, except for the specific cancer under investigation in this trial and any localized cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
	Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication 14 days before the first dose of study drug
	Note: Participants who are currently or have previously been on any of the
	following steroid regimens are not excluded
	Adrenal replacement steroid (dose 10 mg daily of prednisone or equivalent)
	Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption
	Short course ( 7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a non-autoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen)
	NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

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cancer

drug evaluation

breast cancer

epidermal growth factor receptor

measurable disease

metastasis

docetaxel

glomerular filtration rate

human epidermal growth factor

cancer treatment

capecitabine

adenocarcinoma of the breast

gastric cancer

gastric adenocarcinoma

metastatic adenocarcinoma

drug test

epidermal growth factor

cancer therapy

erbb2

cytotoxic chemotherapy

recurrent disease

adenocarcinoma of the gastroesophageal junction

her1

bispecific antibody

tislelizumab

breast cancer, treatment

HER2

EGFR

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