The phase 2 clinical trial of the combination therapy, GT90001 and nivolumab, for the treatment of patients with advanced hepatocellular carcinoma has dosed its first patient.
The first patient has been dosed in the multi-regional, global, phase 2 clinical trial (NCT05178043) of the combination therapy, ALK-1 antibody (GT90001) and nivolumab (Opdivo), for the treatment of patients with advanced hepatocellular carcinoma (HCC), according to Kintor Pharmaceutical Limited.
"We are delighted to complete the first patient dosing in the phase 2 multi-regional clinical trial of GT90001 combined with nivolumab for the treatment of advanced HCC. We expect this phase 2 MRCT study would position GT90001 well as a combination candidate with I/O for the second-line treatment of HCC. We are also selecting clinical strategies for GT90001 in other solid tumors and hope to bring more innovative treatment options for patients with unmet needs," said Tong Youzhi, MD, founder, chairman, and chief executive officer of Kintor Pharmaceutical Limited, in the press release.
Though recent years have shown developments of innovative therapies for patients with liver cancer, the treatment and the prognosis remains relatively poor.
One of the most recently created options for patients with advanced liver cancers is the combination treatment of atezolizumab (Tecentriq) and bevacizumab (Avastin) which was approved in 2020 in the United States. The combination was put in place to replace sorafenib (Nexavar) or Lenvatinib (Lenvima) as the standard of care for patients with advanced HCC, used in the first-line.
An unmet need remains within the second-line for treatment options available for patients who failed treatment with or did not tolerate the combination of atezolizumab and bevacizumab.
The open-label, multi-regional phase 2 clinical trial of GT90001 plus nivolumab was authorized by the FDA in February 2021, to examine the safety and efficacy of the combination in patients with advanced HCC who were intolerant of, or who had progressed after first-line treatment with immune checkpoint inhibitors (ICI).
Enrollment in the trial is open to patients aged 18 and older with a confirmed diagnosis of advanced HCC. Those enrolled are also required to have Barcelona Clinic Liver Cancer (BCLC) stage C disease or BCLC stage B which cannot be helped by locoregional therapy or refractory to locoregional therapy, documented disease progression after or intolerance to first line treatment of ICI, an ECOG performance status of 0 or 1, a life expectancy of greater than 3 months, and adequate hematologic and organ function.
This study aims to enroll 105 patients who will receive the combination therapy of GT90001 at 7mg/kg and nivolumab at 240 mg, given by infusion every 2 weeks. The intravenous (IV) infusion of nivolumab will be given first and will take place over 30 minutes. Following, patients will be given an IV infusion of GT90001 for 60 min.
The primary end point of the trial is to assess the overall response rate (ORR) as evaluated by an independent review committee according to RECIST v1.1, with secondary end points including duration of response, progression-free survival, time to response, time to progression, disease control rate, overall survival, safety, and tolerability.
The FDA had previously granted an investigational new drug application to GT90001 in February 2021, as a second-line treatment for patients with HCC. Following this, the clinical trial examining the combination therapy of GT90001 for the treatment of advanced HCC was approved by the National Medical Products Administration of China in October 2021.