BEIJING (dpa-AFX) - I-Mab (IMAB) said that an expanded Phase 1 monotherapy study of givastomig, a Claudin 18.2 X 4-1BB bispecific antibody immunostimulant, demonstrated promising single-agent activity in heavily pre-treated patients with gastric cancers expressing Claudin 18.2 at low and high levels. The recommended Phase 2 dose for givastomig was determined to be 8-12 mg/kg; givastomig was well tolerated up to the highest study doses. A Phase 1b study, which evaluates givastomig in combination with standard-of-care treatment (nivolumab + chemotherapy (FOLFOX)) in front-line gastric cancer patients, is ongoing.
Key observations from Phase 1 monotherapy study of givastomig include among the 43 patients with CLDN18.2+ gastric cancers who received givastomig monotherapy at doses ranging from 5 to 18 mg/kg, seven patients achieved partial responses (one at 5 mg/kg, one at 8 mg/kg, four at 12 mg/kg, and one at 18 mg/kg), resulting in an objective response rate (ORR) of 16.3% (7/43 patients) for the single agent. Of these seven patients with partial responses, five (71%) had previously received a checkpoint inhibitor. Stable disease (SD) was reported in 14 patients, yielding a disease control rate (DCR) of 48.8% (21/43 patients).
The company noted that no dose-limiting toxicity was observed up to 15 mg/kg administered every two weeks (Q2W) and 18 mg/kg administered every three weeks (Q3W), and a maximum tolerated dose (MTD) was not determined. The most common treatment-related adverse events (TRAEs) were primarily grade 1 or 2.
Givastomig demonstrated linear pharmacokinetics (PK) at doses greater than or equal to 5 mg/kg and exhibited a dose-dependent increase in soluble 4-1BB levels, reaching a plateau at doses between 8 mg/kg and 18 mg/kg.
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