- 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.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Shanghai Henlius Biotech Inc. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260326-12068806), on March 26, 2026, and is solely responsible for the information contained therein.
Comments