Abstract 1439TiP
Background
Standard second-line therapy for patients with recurrent or metastatic gastric or gastroesophageal junction (G/GEJ) cancer includes taxane or irinotecan monotherapy, ramucirumab alone or in combination with paclitaxel. HX008 is a novel highly selective, fully humanized anti-PD-1 monoclonal antibody with an engineered Fc domain. Previous report of HX008 plus irinotecan has demonstrated promising efficacy and manageable safety profile in patients with advanced G/GEJ adenocarcinoma. A phase III trial has been conducted to evaluate the efficacy and safety of HX008 plus irinotecan versus placebo plus irinotecan as second-line treatment in patients advanced G/GEJ adenocarcinoma.
Trial design
Key patient eligibility criteria are histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic G/GEJ adenocarcinoma, has experienced documented objective radiographic or clinical disease progression during or after first-line therapy containing platinum and/or fluoropyrimidine therapy, measurable or non-measurable evaluable disease per RECIST v1.1, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Patients will be randomly assigned 1:1 to HX008 or placebo plus irinotecan. Randomization will be stratified by ECOG performance status (0 vs 1), PD-L1 tumor expression status (combined positive score < 1 vs ≥ 1), time to progression on firstline therapy (<6 months vs ≥ 6 months). HX008 200 mg or placebo will be administered intravenously (IV) every 3 weeks (Q3W), and irinotecan 160 mg/m2 will be administered intravenously (IV) every 2 weeks (Q2W). Patients will continue to receive treatment until disease progression, unaccepted toxicity, physician decision or patient withdrawal of consent, whichever comes first. The primary endpoint is overall survival in all patients and patients with PD-L1 CPS ≥ 1. Secondary endpoints include progression free survival, objective response rate, disease control rate and duration of response per RECIST v1.1 as assessed by investigators as well as safety and tolerability. This trial is currently enrolling.
Clinical trial identification
NCT04486651.
Editorial acknowledgement
Legal entity responsible for the study
Taizhou Hanzhong Biomedical Co., Ltd.
Funding
Taizhou Hanzhong Biomedical Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.