First Patient Dosed in Phase 1b/2 Trial of HLX701 Combination Therapy for Advanced Colorectal Cancer
Shanghai Henlius Biotech announced on March 26, 2026, that the first patient was dosed in the HLX701-CRC201 Phase 1b/2 trial.
The trial evaluates HLX701 (recombinant human SIRPα-Fc fusion protein) combined with cetuximab and chemotherapy (FOLFOX/FOLFIRI) versus placebo in patients with advanced RAS/BRAF wild-type metastatic colorectal cancer who have prior chemotherapy.
The study is in mainland China and includes safety run-in (Stage 1:
dose escalation 5-18 mg/kg), expansion (Stage 2), and randomized efficacy (Stage 3) phases.
HLX701 targets CD47-SIRPα pathway, promoting phagocytosis with high tumor affinity and low hematological risks; preclinical synergy shown with EGFR inhibitors like cetuximab.
NMPA approved the IND application in January 2026; no SIRPα-Fc fusion proteins targeting CD47 are approved globally.