A Phase 1 dose-escalation study to evaluate safety, pharmacokinetics, and pharmacodynamics of OSE-279, an anti-PD-1 monoclonal antibody in patients with advanced solid tumours
Published report from the trial registered as NCT05751798, in European Journal of Cancer (2026), chosen as the most cited paper whose own text cites the registry id.
Overview
Background: OSE-279 is a high affinity humanized monoclonal bivalent antibody against PD-1 with potent antitumor activity in vivo in syngeneic non-clinical models.
Methods: This phase I study assessed the safety, pharmacokinetics, pharmacodynamics and antitumor activity of OSE-279 in advanced solid tumours.
Results: Twenty patients received OSE-279 intravenously at 100 mg q3w (n = 2), 300 mg q3w (n = 7) and 600 mg q6w (n = 11). Median age was 61.5 (range 3-81) years, 50% were female, median number of prior metastatic lines was 2 (range 1-6). Most frequent tumour types were soft tissue sarcoma (n = 4) and anal squamous cell carcinoma (n = 3). OSE-279 monotherapy was safe. Two recommended phase 2 doses were established: 300 mg q3w and 600 mg q6w. The most common (≥10%) related TEAEs were diarrhoea, dry mouth, pruritus, chills, fatigue, headache, dysgeusia and hyperthyroidism. OSE-279 PK exhibited linear dose proportionality and mean receptor occupancy was maintained above 80% in all tested doses. There were 1 CR at 300 mg q3w, 4 PRs at 600 mg q6w and 7 SD with response duration ranging from 6.8 to 18.4 months.
Conclusion: OSE-279 monotherapy was well tolerated with durable responses in patients with advanced solid tumours. The trial is continuing with OSE-279 combined with OSE2101, a therapeutic cancer vaccine in 1st line HLA-A2 positive PD-L1 ≥ 50% NSCLC. CLINICAL TRIAL REGISTRATION (NCT NUMBER: NCT05751798).
Indexed on Europe PMC as PubMed record 42034003 (DOI 10.1016/j.ejca.2026.116729). Its abstract cites the registry id NCT05751798, which is how it was matched to this trial; no figure has been checked by an editor.
This is the paper Europe PMC returns for registry id NCT05751798 with the most citations, so it is the natural first reading for anyone following the trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
- Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.