Innovent Biologics and Laekna Therapeutics have dosed the first subject in a Phase I/II clinical trial of a three-drug combination therapy comprising afuresertib (LAE002), sintilimab (TYVYT) and chemotherapy in specific solid tumour patients.
The first patient with cervical cancer was dosed at the West China Second Hospital of Sichuan University.
The single-arm, multicentre, open-label, dose-escalation Phase I/II clinical trial will analyse recommended Phase II dose (RP2D), safety, tolerability and anti-tumour activity of the triple combination therapy in solid tumour patients who were resistant to previous anti-PD-1/PD-L1 therapy.
Maximum tolerated dose (MTD) and RP2D are the Phase I dose escalation study’s primary endpoints while overall response rate (ORR) is the primary endpoint of the Phase II trial.
The companies plan to expand the trial as a multi-regional study at the pivotal stage.
Five kinds of solid tumours will be analysed in the trial, including non-small cell lung cancer, gastric cancer/gastroesophageal junction cancer, oesophageal cancer, cervical cancer and endometrial cancer.
Laekna Therapeutics chief medical officer Dr Yong Yue said: “There are three main considerations in selecting the five types of solid tumours: PD-1/PD-L1 inhibitors have been approved as the standard-of-care treatments for those cancers in multiple countries; higher rates of biomarkers that activate the AKT pathway in patients with resistance to anti-PD-1/PD-L1 therapy were observed in those cancers and the incidence rates and death rates are relatively high in China.
“We hope this innovative three-drug combination therapy will benefit patients with these solid tumours.”
An investigational highly selective adenosine triphosphate (ATP) competitive AKT inhibitor, Laekna’s afuresertib is being analysed as a potential new treatment for drug resistant-cancer.
Sintilimab is a PD-1 immunoglobulin G4 monoclonal antibody of Innovent. It is currently approved for six indications in China.
Chemotherapy treatment included either nab-paclitaxel or docetaxel.
In July this year, Innovent dosed the first subject in a Phase II trial of IBI112 in moderate-to-severe active ulcerative colitis patients in China.