Anti-HER2 Bispecific Antibody Zanidatamab (ZW25) Activity in Combination With Chemotherapy With/W… (NCT04276493) | Clinical Trial Compass
CompletedPhase 1/2
Anti-HER2 Bispecific Antibody Zanidatamab (ZW25) Activity in Combination With Chemotherapy With/Without Tislelizumab
China71 participantsStarted 2020-03-26
Plain-language summary
The purpose of the study is to assess the safety, tolerability and preliminary antitumor activity of zanidatamab in combination with docetaxel in participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer, and zanidatamab in combination with tislelizumab and chemotherapy in participants with HER2-positive gastric/gastroesophageal Junction (GEJ) adenocarcinoma
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Disease diagnosis and prior treatment:
✓. Cohort 1 (the first-line breast cancer treatment cohort):
✓. Cohort 2 (the first-line gastric/gastroesophageal junction adenocarcinoma treatment cohort):
✓. At least 1 measurable lesion as defined per RECIST Version 1.1
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
✓. Adequate organ function
✓. 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
✕. Active leptomeningeal disease, untreated or uncontrolled brain metastasis
✕. 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)
What they're measuring
1
Number of Participants experiencing Adverse Events (AEs)
Timeframe: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 41 months
2
Number of Participants experiencing Serious Adverse Events (SAEs) as assessed by the investigator.
Timeframe: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 41 months
3
Objective response rate (ORR)
Timeframe: From the start date of study treatment to the first documentation of progression or death, whichever occurs first, up to approximately 41 months
✕. 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
✕. 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)