Phase 2 hepatocellular carcinoma therapy.
Kintor Pharmaceutical has dosed the first subject in the US under the Phase II clinical trial of a combination of ALK-1 antibody, GT90001, and nivolumab (Opdivo) to treat advanced hepatocellular carcinoma (HCC).
A fully human IgG2 neutralizing monoclonal antibody, GT90001 hinders BMP9 and TGFβ through ALK-1 receptor-mediated signal transduction and angiogenesis of tumors.
The multi-regional, open-label trial obtained clearance from the US Food and Drug Administration in February last year.
It will assess the safety and efficacy of GT90001 plus Nivolumab in advanced HCC patients who were not tolerant or have advanced following first-line treatment with immune checkpoint inhibitors (ICI) such as Atezolizumab and/or Bevacizumab, or ICI plus tyrosine kinase inhibitor (TKI).
This trial will have 105 subjects who will be given an infusion of the combination therapy every two weeks.
Evaluating the overall response rate (ORR) as analyzed by an independent review committee (IRC) in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is the trial’s primary endpoint.
Kintor Pharma founder, chairman and CEO Dr Tong Youzhi said: “We are delighted to complete the first patient dosing in the Phase II multi-regional clinical trial of GT90001 combined with Nivolumab for the treatment of advanced HCC.
“We expect this Phase II MRCT study would position GT90001 well as a combination candidate with I/O for the second-line treatment of HCC.”
According to the initial findings from an ongoing Phase II trial for advanced HCC in Taiwan, the ALK-1 antibody demonstrated favorable safety data.