Transcenta Holding Limited (HKEX:06628), a China-based clinical stage biopharmaceutical company, announced on Wednesday that it has dosed its first subject in the United States phase one study of TST003 (NCT05731271), its first-in-class, high affinity humanised monoclonal antibody targeting Gremlin1, intended to treat solid tumours.

NCT05731271 is an open-label, dose escalation, FIH study designed to evaluate the safety, tolerability, and pharmacokinetics profile of TST003 as a treatment in patients with solid tumours. The company said that TST003 has demonstrated promising single agent and combination activities in patient-derived xenograft tumour models from the difficult-to-treat solid tumours resistant to checkpoint inhibitors including castration resistant prostate cancer and microsatellite stable colorectal cancer.

Dr Caroline Germa, Transcenta's EVP, Global Medicine Development and CMO, said, 'The enrolment and dosing of the first patient in the US marks a very significant milestone for TST003: our carefully designed Phase 1 will provide the necessary clinical and translational data to achieve the full potential of targeting Gremlin1 as a single agent or in combinations with standard of care, in particular in indications with high unmet need like MSS CRC or CRPC.'