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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May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.