Shanghai Henlius Biotech Reports the First Patient Dosing of HLX15 (biosimilar, daratumumab) in P-I Clinical Trial for Multiple Myeloma


The first patient has been dosed in the P-I trial that consists of 2 parts (parts 1 & 2) evaluating HLX15 (anti-CD38 IgG1κ mAb) vs daratumumab in 234 patients with MM
Part 1 is an open-label, two-arm P-Ia study & part 2 is a three-arm P-Ib study evaluating HLX15 (8mg/kg) vs China & US-sourced daratumumab in a ratio (1:1) & (1:1:1) in 24 & 204 patients while part 2 is a three-arm P-Ib study. The early phase of part 1 includes a safety run-in period with 3-6 patients to receive HLX15 (IV), monitored for safety for 1wk.
The 1EP is the area under the serum drug concentration-time curve from time 0 to infinity & 2EPs incl. other PK parameters, safety & immunogenicity. In preclinical studies, HLX15 is highly similar to daratumumab

Ref: Henlius | Image: Henlius

Related News:- Henlius’ HLX15 (biosimilar- daratumumab) Receives IND Approval for Multiple Myeloma in China