First Patient Dosed in Phase II/III Clinical Trial of Henlius Anti-PD-1 mAb HLX10 Combined with Bevacizumab for the First-line Treatment of mCRC
With the continuous development of "Combo+Global" strategy of HLX10 and diversified pipeline of innovative drug candidates of Company, Henlius is actively accelerating innovation transformation, improving innovation efficiency, and committing to bringing high-quality and affordable innovative biologics to patients around the world.
About NCT04547166
This is a multi-centre, randomised, double-blind, parallel-controlled, three-stage phase II/III study, aimed to evaluate HLX10 combined with HLX04 and chemotherapy (XELOX) versus placebo combined with Avastin??and chemotherapy (XELOX), as first-line treatment for metastatic colorectal cancer (mCRC). Stage 1 is a single-arm safety run-in study primarily aimed to evaluate the safety and tolerability of HLX10 combined with HLX04 and chemotherapy as first-line treatment in mCRC patients. Stage 2 is a multicentre, randomised, double-blind, parallel-controlled phase II study whose primary objective is to compare the efficacy between two treatment groups through the evaluation of progression-free survival (PFS). Secondary objectives include the evaluation of other efficacy endpoints, pharmacokinetic profiles, safety, and tolerability. Stage 3 is a phase III study that will be conducted based on the phase II primary efficacy results, and it follows the study design and has the same primary and secondary objectives as phase II study.
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