ArticleESMO open2026
Safety, pharmacokinetics, pharmacodynamics, and antitumor activity of cergutuzumab amunaleukin: a phase I study in patients with advanced and/or metastatic solid tumors.
Article in ESMO open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Biomarkers of activity from a phase I study of cergutuzumab amunaleukin in patients with advanced solid tumors.Journal for immunotherapy of cancer · 2026Article
- Immunocytokines in cancer: a safety perspective.Frontiers in immunology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
25 authors.
Funding
Abstract
backgroundCergutuzumab amunaleukin (CA) is a novel immunocytokine comprising an interleukin-2 variant moiety with abolished CD25 (interleukin-2 receptor α) binding, fused to a bivalent anti-carcinoembryonic antigen (CEA) monoclonal antibody. This first-in-human phase I study evaluated the maximum tolerated dose (MTD), safety, pharmacokinetics, pharmacodynamics, and antitumor activity of CA. MATERIAL AND
methodsPatients had CEA-positive advanced and/or metastatic solid tumors that had progressed on standard-of-care treatment. The study consisted of two parts: patients received single-dose CA 0.1-6 mg (n = 5) in part I and multiple ascending doses of 10-40 mg every 2 weeks (q2w; n = 31) or 6-30 mg weekly (qw; n = 24) in part II. Patients with advanced renal cell carcinoma or melanoma (CEA-negative) were permitted in part II.
resultsSixty patients were enrolled. Most common primary tumor sites in part I, part II q2w, and part II qw were the colon (40%, 44%, and 57%, respectively) and rectum (40%, 19%, and 14%, respectively). Four dose-limiting toxicities (DLTs) established an MTD of 30 mg q2w [grade (Gr)4 hypophosphatemia and thrombocytopenia at 40 mg; Gr2 capillary leak syndrome and Gr3 fatigue at 30 mg]. Dose escalation was halted in the qw regimen due to DLTs at 25 mg (Gr3 hypotension and thrombocytopenia). The most frequently reported adverse events were pyrexia (68%) and infusion-related reaction (52%). The pharmacokinetics of CA were consistent with target-mediated drug disposition, but approximate dose-proportional exposure was observed at 6-40 mg doses. In the blood, CA preferentially and significantly expanded CD8+ T cells and natural killer cells, but not regulatory T cells (T
conclusionsConsistent with its mechanism of action, CA had a manageable safety profile and expanded immune effector cells but not T
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