Sign in Subscribe
Cancer research

I-Mab Biopharma Announces Completion of Phase 1b Dose Expansion Cohorts for Givastomig in Combination with Nivolumab and mFOLFOX6

Strategic Insights

— 1 min read

I-Mab Biopharma has announced the completion of enrollment in the planned Phase 1b dose expansion cohorts evaluating givastomig, a bispecific Claudin 18.2 x 4-1BB antibody, in combination with nivolumab and mFOLFOX6, for the treatment of gastric cancer. The Phase 1b study, which enrolled 40 patients in the U.S., evaluated the safety, efficacy, pharmacokinetics, and pharmacodynamics of givastomig in patients with CLDN18.2-positive gastric cancers. The data from the dose escalation cohorts showed an 83% objective response rate (ORR) at the selected doses, with rapid, durable, and deepened responses over time.

Key Takeaways:

  • I-Mab Biopharma has completed enrollment in the Phase 1b dose expansion cohorts for givastomig in combination with nivolumab and mFOLFOX6, a treatment for gastric cancer.
  • The study enrolled a total of 40 patients in the U.S. across two doses (8 mg/kg and 12 mg/kg).
  • The primary endpoint of the study is safety, with secondary endpoints including efficacy, pharmacokinetics, and pharmacodynamics.
  • The data from the dose escalation cohorts showed an 83% objective response rate (ORR) at the selected doses, with rapid, durable, and deepened responses over time.
  • The study's investigators and I-Mab's management have expressed optimism about the potential of givastomig to become a new treatment option for patients with Claudin 18.2-positive gastric cancers.
  • Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab, thanked the patients, their families, investigators, and study sites for their support and expressed hope that givastomig can become a new treatment option.
  • The data were presented on July 2, 2025, at the European Society for Medical Oncology Gastrointestinal Cancers Congress (ESMO GI) 2025 in Barcelona, Spain.

Statistics:

  • 40 patients were enrolled in the Phase 1b dose expansion cohorts.
  • 10/12 patients (83%) achieved an objective response rate (ORR) at the selected doses.
  • The study enrolled patients with CLDN18.2-positive gastric cancers, with [?]1% of cells displaying [?]1+ intensity.

Sources:

  • "I-Mab (NASDAQ: IMAB) Press Release"
  • NCT04900818 (Phase 1b study of givastomig in combination with nivolumab and mFOLFOX6)
  • European Society for Medical Oncology Gastrointestinal Cancers Congress (ESMO GI) 2025 in Barcelona, Spain
  • I-Mab hosted a virtual investor event on July 8, 2025, reviewing the Phase 1b dose escalation data (accessible for viewing here)

Read more