What question did this study set out to answer?

To assess the safety, maximum tolerated dose, pharmacokinetics, and preliminary clinical efficacy of the humanized anti-glypican-3 monoclonal antibody GC33 in patients with advanced hepatocellular carcinoma.

January 30, 2013Clinical Cancer ResearchOpen Access

First-in-Man Phase I Study of GC33, a Novel Recombinant Humanized Antibody Against Glypican-3, in Patients with Advanced Hepatocellular Carcinoma

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To assess the safety, maximum tolerated dose, pharmacokinetics, and preliminary clinical efficacy of the humanized anti-glypican-3 monoclonal antibody GC33 in patients with advanced hepatocellular carcinoma.
Enrolled 20 patients with histologically confirmed, advanced hepatocellular carcinoma into a phase I dose-escalation trial evaluating weekly intravenous GC33 at doses ranging from 2.5 to 20 mg/kg.
Assessed pharmacokinetics in serum samples, measured tumor glypican-3 (GPC3) expression using immunohistochemistry on biopsies, and evaluated radiographic tumor response every 8 weeks via RECIST.
No dose-limiting toxicities were observed up to the maximum planned dose of 20 mg/kg, and the maximum tolerated dose was not reached.
Most frequent adverse events across all grades were fatigue (50%), constipation (35%), headache (35%), and hyponatremia (35%), with no apparent dose dependency.
Median time to progression was significantly longer in the GPC3 high expression group at 26.0 weeks versus 7.1 weeks in the low expression group (P = 0.033).

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Implication

Phase I trial demonstrates safety and prolonged time to progression in glypican-3-high advanced hepatocellular carcinoma, indicating potential biomarker-driven efficacy.

Cite This Study

Zhu et al. (2013) studied this question.

synapsesocial.com/papers/6a0fee7b9e54838161fd6cb5 https://doi.org/10.1158/1078-0432.ccr-12-2616

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Implication

Phase I trial demonstrates safety and prolonged time to progression in glypican-3-high advanced hepatocellular carcinoma, indicating potential biomarker-driven efficacy.

First-in-Man Phase I Study of GC33, a Novel Recombinant Humanized Antibody Against Glypican-3, in Patients with Advanced Hepatocellular Carcinoma

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Discussion

Implication

Cite This Study

First-in-Man Phase I Study of GC33, a Novel Recombinant Humanized Antibody Against Glypican-3, in Patients with Advanced Hepatocellular Carcinoma

Key Points

Discussion

Implication

Cite This Study

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