US-based clinical-stage biopharmaceutical company MacroGenics has dosed the first patient in a Phase I study of its investigational therapy, MGC030, for advanced solid tumours.
MGC030 is an antibody-drug conjugate (ADC) directed at an undisclosed antigen found on multiple types of solid tumours.
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The open-label, multi-centre trial incorporates dose escalation, dose optimisation, and cohort expansion stages.
Up to 54 individuals will be enrolled in the initial escalation phase, with the potential to increase enrolment further at chosen dosing tiers.
Eligible participants must have unresectable, locally advanced, or metastatic solid tumours that have relapsed or proved refractory to prior care.
Enrolment encompasses colorectal, oesophageal, gastric or gastroesophageal junction, pancreatic, and urothelial cancers.
Investigators designed the trial to determine the pharmacokinetics, preliminary antitumour activity, tolerability, safety, and immunogenicity of MGC030. The protocol also evaluates potential biological markers connected to these clinical measures.
MacroGenics senior vice-president and chief scientific officer Ezio Bonvini said: “MGC030 demonstrated encouraging antitumour activity in multiple preclinical models, and we look forward to advancing this product candidate through the Phase I study.
“We expect that this trial will deepen our understanding of how the molecule may help address the unmet needs of patients with selected advanced solid tumours.
“The dosing of a first patient with MGC030 builds upon the strong early-stage clinical momentum we have sustained across our innovative ADC pipeline, as this molecule is now our third ADC in active clinical development.”
MGC030 integrates technology licensed from Synaffix alongside the SYNtecan E linker-payload, a topoisomerase I inhibitor construct featuring an exatecan cytotoxic agent joined at a drug-to-antibody ratio of 4.
Laboratory testing before the trial showed antitumour responses across several animal models, alongside safety and tolerability observations recorded during toxicology assessments in cynomolgus monkeys.
MacroGenics uses internal antibody engineering platforms to create monoclonal antibody-based cancer treatments and maintains partnerships with international biotechnology and pharmaceutical corporations.
