This phase Ib study aims to assess the safety and feasibility of combination of chimeric receptor T cells with trastuzumab in patients with HER2+ solid tumors, with further expansion of study population in HER2+ metastatic breast cancer once safety has been established.
Age ≥ 21 years.
Phase I: HER2-positive breast or gastric cancer or other treatment-refractory HER2-positive solid tumors
Phase II : HER2-positive breast carcinoma
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Treatment within the last 30 days with any investigational drug.
Concurrent administration of any other tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
Major surgery within 28 days of study drug administration.
Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
National University Hospital, Singapore
Lead sponsor