Shanghai Henlius Biotech doses first patient in Phase 1b/2 HLX701 combo trial for advanced colorectal cancer in Chinese mainland; study compares HLX701 plus cetuximab and FOLFOX/FOLFIRI versus placebo combo

Reuters03-26
<a href="https://laohu8.com/S/SGBCF">Shanghai Henlius Biotech</a> doses first patient in Phase 1b/2 HLX701 combo trial for advanced colorectal cancer in Chinese mainland; study compares HLX701 plus cetuximab and FOLFOX/FOLFIRI versus placebo combo
  • Henlius reported that the first patient has been dosed in a Phase 1b/2 study of HLX701, a recombinant human SIRPα-IgG4 Fc fusion protein, in combination with cetuximab and chemotherapy for advanced colorectal cancer in Chinese Mainland.
  • The trial compares HLX701 plus cetuximab and FOLFOX or FOLFIRI versus placebo plus cetuximab and the same chemotherapy in patients with recurrent, unresectable, or metastatic RAS/BRAF wild-type colorectal cancer previously treated with chemotherapy.
  • Stage 1 uses a 3+3 dose-escalation design across 4 weekly IV dose levels from 5 mg/kg to 18 mg/kg, with a primary endpoint of dose-limiting toxicities.
  • Stages 2 and 3 assess objective response rate and progression-free survival by blinded independent central review, and Stage 3 is randomized, double-blind, and multi-center.
  • No clinical results were reported in the announcement, and future presentation of results was not specified.


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