MacroGenics Announces First Patient Dosed in Phase 1 Study of MGC030 in Patients with Advanced Solid Tumors

MGC030 becomes the company's third antibody-drug conjugate in active clinical development.

Rhea-AI Summary

MacroGenics (MGNX) has dosed the first patient in its Phase 1 study of MGC030 in patients with advanced solid tumors. MGC030 is an antibody-drug conjugate, an antibody linked to a drug, directed against an undisclosed target and is the company's third such candidate in active clinical development.

The open-label, multi-center study will assess safety, tolerability, drug behavior in the body, immune responses and preliminary antitumor activity, while exploring associated biomarkers. Dose escalation will enroll up to 54 participants, with potential expansion at selected doses. Eligible patients have relapsed or treatment-resistant solid tumors that cannot be surgically removed, are locally advanced or have spread.

Positive

• Minor pointFirst patient dosed advances MGC030 into Phase 1 testing for advanced solid tumors.
• Minor pointThird antibody-drug conjugate is now in active clinical development at MacroGenics.

Negative

• None.

Key Figures

Dose-escalation enrollment: Up to 54 participants

Dose-escalation enrollment

Up to 54 participants

MGC030 Phase 1 study

Key Terms

antibody-drug conjugate, pharmacokinetics, immunogenicity, open-label, +1 more

5 terms

antibody-drug conjugate medical

"a first-in-class antibody-drug conjugate (ADC)"

An antibody-drug conjugate is a targeted medicine that combines an antibody, which can identify specific cells, with a powerful drug designed to destroy those cells. This approach allows for precise treatment, minimizing damage to healthy tissue. For investors, developments in this area can signal advances in cancer therapies and potential growth opportunities in the biotech sector.

pharmacokinetics medical

"safety, tolerability, pharmacokinetics (PK), immunogenicity"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

immunogenicity medical

"pharmacokinetics (PK), immunogenicity and preliminary antitumor activity"

Immunogenicity is the ability of a substance, such as a vaccine or medication, to provoke an immune response in the body. It matters to investors because high immunogenicity can affect the effectiveness and safety of a product, potentially leading to increased costs or regulatory challenges. Understanding immunogenicity helps assess the long-term viability and market potential of pharmaceutical and biotech investments.

open-label medical

"Phase 1, open-label, multi-center"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

dose-escalation medical

"multi-center, dose-escalation, dose-optimization and cohort-expansion study"

Dose-escalation is the part of an early-stage clinical trial where researchers gradually increase a drug’s dose in small groups of participants to find the safest and most effective amount. Think of it like turning up the volume slowly to find the sweet spot: investors watch these results closely because they reveal safety risks, potential effectiveness, and how quickly a drug can move to later trials or approval, all of which affect the development timeline and commercial prospects.

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ROCKVILLE, MD, Oct. 15, 2026 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, today announced 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.

“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.

About MacroGenics, Inc.

MacroGenics (the Company) is a biopharmaceutical company focused on developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company’s website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

Cautionary Note on Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for MacroGenics (“Company”), including statements about the Company’s strategy, future operations, clinical development of and regulatory plans for the Company’s therapeutic candidates, expected timing of the release of clinical updates and safety and efficacy data for the Company’s ongoing clinical trials, anticipated cash runway and other statements containing the words “subject to”, "believe", “anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential”, “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy, including our ability to execute on our key strategic priorities for 2026, constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks related to the reproducibility of any results initially seen in any product candidate including the preclinical results for MGC030 discussed herein; risks that any product candidate’s revenue, expenses and costs may not be as expected; risks relating to any other product candidate’s market acceptance, competition, reimbursement and regulatory actions; future data updates for MGC030 or any other product candidates, including timing and results of efficacy and safety data with respect to MGC030 or any other product candidates in ongoing clinical trials; the uncertainties inherent in the initiation and enrollment of future clinical trials; the availability of financing to fund the internal development of our product candidates; expectations regarding the expansion of ongoing clinical trials; expectations for the timing and steps required in the regulatory review process; expectations for regulatory approvals; expectations of future milestone payments; the impact of competitive products; our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates; business, economic or political disruptions due to catastrophes or other events, including natural disasters, terrorist attacks, civil unrest and actual or threatened armed conflict, or public health crises; costs of litigation and the failure to successfully defend lawsuits and other claims against us; risks related to the transition of the CDMO operations to the purchaser following the sale of our CDMO operations; and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

CONTACTS:

Jim Karrels, Senior Vice President, CFO
1-301-251-5172
info@macrogenics.com

Argot Partners
1-212-600-1902
macrogenics@argotpartners.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What will MacroGenics' Phase 1 MGC030 study evaluate?

The study will evaluate safety, tolerability, drug behavior in the body, immune responses and preliminary antitumor activity. It will also explore biomarkers associated with these measures. The open-label, multi-center study includes dose escalation, dose optimization and cohort expansion.

Which cancers are included in MacroGenics' MGC030 Phase 1 study?

The study will enroll patients with urothelial, colorectal, gastric or gastroesophageal junction, esophageal, and pancreatic cancers, among other solid tumors. Participants must have relapsed or treatment-resistant tumors that cannot be surgically removed, are locally advanced or have spread.