A Phase I Study of PF-07062119, an Anti-GUCY2C/Anti-CD3 Bispecific Fc Antibody, in Patients with Advanced Gastrointestinal Cancers.
Cancer Res CommunOct 1, 2026
Marwan Fakih, Toshihiko Doi, Anthony Tolcher et al.
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In 30 seconds
This Phase I multicenter study evaluated PF-07062119, an anti-GUCY2C/anti-CD3 bispecific antibody, in 79 patients with advanced gastrointestinal cancers. The study assessed safety, tolerability, and antitumor activity, finding a maximum tolerated dose of 800 μg without a priming dose. The overall response rate was 2.5%, indicating limited clinical activity.
Key findings
- Maximum tolerated dose without a priming dose was 800 μg, with dose-limiting toxicities including grade 3 cytokine release syndrome.
- Treatment-related grade 3/4 adverse events occurred in 34.2% of patients, with diarrhea being the most significant.
- A 400 μg priming dose reduced the incidence of cytokine release syndrome.
- The overall response rate across all cohorts was 2.5%.
Why it matters
Understanding the safety and efficacy of new treatments like PF-07062119 is crucial for advancing therapeutic options in patients with advanced gastrointestinal cancers, particularly given the limited response rates observed.