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Colorectal Cancer Treatments and Studies / Monoclonal and Polyclonal Antibodies Research / HER2/EGFR in Cancer Research · Journal article
Cancer Research Communications · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This first-in-human Phase 1 study of PF-07062119, a bispecific antibody targeting GUCY2C and CD3, established a maximum tolerated dose of 800 μg without priming, with a recommended expansion dose of 2100 μg following a 400 μg priming dose and premedication strategy. Safety was the primary focus; grade 3/4 treatment-related adverse events occurred in 34.2% of patients, dominated by diarrhea, cytokine release syndrome, and colitis, with no treatment-related deaths. Objective anti-tumor activity was minimal (2.5% overall response rate), typical for early-phase bispecific antibody studies.
Phase 1, first-in-human, open-label dose-escalation study with combination expansion cohorts. Patients with advanced gastrointestinal cancers expressing GUCY2C. Intervention: PF-07062119 (anti-GUCY2C/anti-CD3ε bispecific Fc antibody), escalating doses 45–3700 μg SC, with or without priming dose and premedication; in Part 1B combined with sasanlimab or bevacizumab. n = 79.
Maximum tolerated dose without priming: 800 μg; recommended expansion dose: 2100 μg with 400 μg priming dose and premedication Grade 3/4 treatment-related TEAEs in 27 (34.2%) of 79 patients; no grade 5 treatment-related TEAEs Dose-limiting toxicities at MTD: grade 3 cytokine release syndrome, colitis, and diarrhea
Primary endpoints were safety and tolerability; anti-tumor activity is a secondary endpoint with no comparator arm Dose-limiting toxicities at MTD: grade 3 cytokine release syndrome, colitis, and diarrhea
This Phase 1 establishes a tolerable dosing strategy and safety profile for PF-07062119, informing future development in this patient population. The low response rate at this stage does not preclude clinical utility; optimal dosing and combination strategies require further evaluation in Phase 2 studies.
First-in-human Phase 1 dose escalation with primary focus on safety and tolerability; anti-tumor activity is secondary and minimal (2.5% ORR), consistent with early-phase exploratory work.
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Quoted from the source exactly as published.
This Phase 1 establishes a tolerable dosing strategy and safety profile for PF-07062119, informing future development in this patient population. The low response rate at this stage does not preclude clinical utility; optimal dosing and combination strategies require further evaluation in Phase 2 studies.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Abstract Purpose: PF-07062119 is an anti-GUCY2C/anti-CD3ε bispecific Fc antibody designed to elicit systemic anti-tumor immunity. This phase 1, first-in-human study evaluated the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, immunogenicity, and anti-tumor activity of PF-07062119 as monotherapy and in combination with sasanlimab or bevacizumab in patients with advanced gastrointestinal cancers expressing GUCY2C. Patients and Methods: Patients received escalating doses of PF-07062119 (45–3700 μg subcutaneously [SC]) in Part 1A. In Part 1B, PF-07062119 was administered with either sasanlimab (300 mg SC) or bevacizumab (5 mg/kg intravenously). Primary endpoints were safety and tolerability; secondary endpoints included PK, immunogenicity and efficacy. Results: A total of 79 patients were enrolled. In Part 1A, maximum tolerated dose without a priming dose was 800 μg. Dose-limiting toxicities observed at this level were grade 3 cytokine release syndrome (CRS), colitis, and diarrhea. A 400 μg priming dose with premedication reduced CRS incidence and recommended dose for expansion was 2100 μg. Treatment-related grade 3/4 treatment-emergent adverse events (TEAEs) were observed in 27 (34.2%) patients, with no grade 5 treatment-related TEAEs. Diarrhea remained the most clinically significant toxicity in Part 1A. Combination therapy in Part 1B did not result in significant additional toxicity. PK analyses demonstrated dose-proportional increases in exposure. The overall response rate was 2.5% across all cohorts. Conclusions: PF-07062119 monotherapy demonstrated a generally tolerable safety profile within the context of this early-phase study with evidence of clinical activity in patients with advanced/metastatic gastrointestinal cancers. Clinical trial information: NCT04171141
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