Phase 1b/2 study of ADG106, a 4-1BB/CD137 agonist, in combination with toripalimab in patients with advanced solid tumors.

ABSTRACT: This phase 1b/2 clinical trial (NCT04775680) evaluated the safety, efficacy, pharmacokinetics and pharmacodynamics of ADG106, a ligand-blocking agonistic antibody targeting CD137 (4-1BB), combined with toripalimab in patients with advanced malignancies. ADG106 0.75-3 mg/kg plus toripalimab 240 mg were administered every 3 weeks. One dose-limiting toxicity occurred in 1 subject at 1.5 mg/kg and 2 in another subject at 3 mg/kg. Grade ≥ 3 treatment related adverse events occurred in 4/25 patients (16%). The overall disease control rate was 29.2% (7/24), including 1 partial response (PR) patient with a duration of response and a progression-free survival of 17.6 and 24.5 months. Circulating biomarkers suggested increased soluble CD137, CD3^-CD16⁺CD56⁺ natural ki

SUBMITTER: Lin S 

PROVIDER: S-EPMC12104636 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature