On October 15, 2026 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, reported that the first patient has been dosed in the Phase 1 study of MGC030, a first-in-class antibody-drug conjugate (ADC) directed against an undisclosed target, in patients with advanced solid tumors.
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"MGC030 demonstrated encouraging antitumor activity in multiple preclinical models, and we look forward to advancing this product candidate through the Phase 1 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 tumors," said Ezio Bonvini, M.D., Senior Vice President and Chief Scientific Officer of MacroGenics. "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."
The Phase 1, open-label, multi-center, dose-escalation, dose-optimization and cohort-expansion study of MGC030 is designed to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary antitumor activity of MGC030, as well as explore biomarkers that may be associated with these endpoints. Participants with relapsed or refractory solid tumors that are unresectable, locally advanced, or metastatic, including urothelial, colorectal, gastric or gastroesophageal junction, esophageal, and pancreatic cancers, will be enrolled. The dose escalation portion of the study will enroll up to 54 participants with the potential to further expand enrollment at selected dose levels.
About MGC030
MGC030 is a clinical-stage ADC that targets an undisclosed antigen expressed across several solid tumors. There are currently no approved therapeutics directed against this target. MGC030 incorporates Synaffix’s proprietary ADC technology and the SYNtecan E topoisomerase I inhibitor-based linker-payload, which consists of a cleavable, exatecan-based cytotoxic payload conjugated at a drug-to-antibody ratio (DAR) of 4.
MGC030 has demonstrated potent antitumor activity in multiple in vivo models and an encouraging safety and tolerability profile in cyno tox studies. The ongoing Phase 1 study of MGC030 is an open-label clinical trial evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC030 in patients with advanced solid tumors. Additional information about the study is available at www.clinicaltrials.gov using the identifier NCT07822399.
(Press release, MacroGenics, OCT 15, 2026, View Source [SID1234673493])